Building Excellence in Clinical Research and Clinical Trials by ohi023

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									                        Université d’Ottawa
                        University of Ottawa
             Centre de recherche en biopharmaceutique & biotechnologie
             Centre for Research in Biopharmaceuticals & Biotechnology


                       Final Proceedings of an Ottawa Regional Conference
            “Building excellence in clinical research and clinical trials”
                                             February 10 &11, 2005,
                                             The Sheraton Ottawa,
                                               150 Albert Street,
                                                    Ottawa




                                                   Sponsored by:




                                        University of Ottawa Project Team

Monique Bégin                Judy Erola                        George Wells           J. André Potworowski
Visiting Professor,          Advisory Board                    Chair, Epidemiology    Project Director
Health Administration,       MHA Program                       & Community Medicine   Centre for Research in
and Professor Emeritus,      School of Management              Faculty of Medicine    Biopharmaceuticals &
Health Sciences                                                                       Biotechnology
                           Ottawa Regional Conference

   “Building Excellence in Clinical Research and Clinical Trials”



  This is the first conference in Canada focused on improving the clinical research and
  clinical trials environment on a regional basis.

      The Conference will:
         • Bring together for the first time all the stakeholders in the clinical research
            and testing of new drugs in the Ottawa region, and highlight their roles and
            contribution,
         • improve interactions and communication between Ottawa Region
            stakeholder groups,
         • flag any steps in clinical trials projects that can be considered obstacles or
            hindrances,
         • share specific solutions and best practices to significantly improve system
            performance and promote excellence in clinical trials and clinical research,
         • build bridges among stakeholders to build up regional capacity,
         • develop initiatives for the Ottawa region, with a plan to implement them,
         • identify a structure to oversee and coordinate these initiatives, and evolve it
            to a self-sustaining cluster for excellence in clinical trials and clinical
            research.




                                      Steering Committee


François Bertrand        Robert Peterson          Ken Lawless              Raphael Saginur
Merck Frosst             Health Canada            Ottawa Life Sciences     Ottawa Hospital
                                                  Council                  Research Ethics Board

Stuart Macleod           Ronald G. Worton         Alex MacKenzie           Joe Irvine
University of British    Ottawa Health            Children’s Hospital of   University of Ottawa
Columbia                 Research Institute       Eastern Ontario          Heart Institute

Anthony Krantis          Zul Merali               Nestor Nituch
Centre for Research in   Institute of Mental      Bristol Myers Squibb
Biopharmaceuticals &     Health Research
Biotechnology,           University of Ottawa
University of Ottawa



     For program information, contact Dr. J. André Potworowski, CRBB, (613) 746-9600,
               potworowski@management.uottawa.ca or visit www.crbb.org.
                                                -2-
PROGRAM: Day 1 Thursday, February 10, 2005
              Chair: The Hon. Judy Erola, PC

8:30 am       Continental Breakfast and Registration
9:00 am       Opening
              Dr. Peter Walker, Dean, Faculty of Medicine, University of Ottawa
9:15 am       Setting the context: Review of the report “Accelerating access for
              patients to best medicine: The system and the challenge” and
              subsequent findings
              Monique Bégin, Judy Erola, George Wells & André Potworowski,
              University of Ottawa
9:50 am       Clinical trial: Benefits to patients and the health care system
              Paul Hébert, Professor of Medicine, Anesthesiology, Surgery, and
              Epidemiology, University of Ottawa
10:10 am      Canada’s biopharmaceutical pipeline: Forecasting Canada’s clinical
              trial activity
              Ken Lawless, President & CEO, Ottawa Life Sciences Council and Rick
              Norland, Executive Director, Centre for Biopharmaceutical Manufacturing.
10:30 am      Refreshments and Networking
11:00 am      The Patient Perspective: What patients want and don’t want from
              Clinical Trials,
              Panel Chaired by Monique Bégin, with Deanna Silverman, Donna
              Marcelissen.
11:45 am      A private research clinic as a management model
              Pierre Gervais, President and Director of Research, Q&T Research Inc.,
              Sherbrooke, Quebec.
12:05 pm       Lunch
1:30 pm       The current and future situation of clinical trials and clinical
              research in the Ottawa Hospital
              Ron Worton, CEO and Scientific Director, the Ottawa Health Research
              Institute
1:40 pm       Patiently Crossing the Intersection at Industry and Academia.
              George Wells, Department of Epidemiology and Community Medicine,
              University of Ottawa
2:00 pm       Breakout groups:
              Sharing by participants of their views, experience and issues with respect
              to clinical research in the Ottawa region,
           a) Do we want more clinical trials in the region, industry-sponsored or led vs.
              peer- reviewed or investigator-sponsored, and what should be the
              balance?
           b) What are the most important/time consuming steps and obstacles to
              carrying out more and better clinical research at the regional level.
3:00 pm       Refreshments and Networking
3:30 pm       Reporting back to plenary session, Summary of key issues (Panel)
5:00 pm       Cocktail Reception and Networking (Penthouse A&B)
PROGRAM: Day 2 Friday, February 11, 2005
           Chair: The Hon. Monique Bégin, PC, OC, FRSC

8:30 am    Special Presentation
           Pierre Meulien, CEO, Dublin Molecular Medicine Centre, Ireland
9:00 am    Panel Discussion: What does Industry want out of an ideal clinical
           research site?
           Chaired by André Potworowski, with François Bertrand - Merck Frosst,
           François Le Barbenchon - Covance Canada Inc, Ken Newport - PRA
           International, Nestor Nituch - Bristol Myers Squibb, Sven Blumenstiel -
           IBM
10:00 am   CIHR's Clinical Research Initiative - Transforming Canadian Clinical
           Research Capacity for the 21st Century
           John Cairns, Project Director, CIHR Clinical Research Initiative
10:30 am   Refreshments and Networking
11:00 am   A Model that works: The Ontario Cancer Research Network
           Robert Phillips, President & CEO, Ontario Cancer Research Network
           A Central Research Ethics Board: opportunities and challenges
           Ray Saginur, Ottawa Hospital Research Ethics Board
11:45 am   A new paradigm for drug development in Canada
           Robert Peterson, Director General, Therapeutic Products Directorate,
           Health Canada
12:05 pm   Improving governance and contracting procedures for clinical
           research
           Rob Hanlon, OHRI and Nestor Nituch, Bristol Meyers Squibb
12:25 pm   Lunch
1:30 pm    Panel Discussion: How can regional hospitals collaborate
           Chaired by Ron Worton - OHRI, with David Moher - CHEO, Larry
           Chambers - Sisters of Charity Ottawa Health Services, Brian Malcolmson
           - Hôpital Monfort, David Crowe - Queensway Carleton Hospital, Zul
           Merali - Royal Ottawa Hospital, Rob Roberts - University of Ottawa Heart
           Institute
2:30 pm    Breakout groups
           Discussion on best practices (Possible themes: training, CRAs, REBs,
           patient recruitment, investigators, industry-sponsored vs. peer reviewed
           trials, regulatory climate, hospital management and collaboration)
           Prioritizing of best practices and new solutions, and
           action/implementation plan
3:15 pm    Refreshments and Networking
3:45 pm    Reporting to plenary session
4:30 pm    Suggested coordinating structure, Champion
4:45 pm    Final summing-up (Panel), debrief, and conclusion.




                                                                                      4
                                                   Table of Contents

KEY CONCLUSIONS FROM CONFERENCE .....................................................8

FEBRUARY 10, 2005 .........................................................................................10

1.      Introduction............................................................................................................. 10

2.      Opening Statement.................................................................................................. 10

3. Setting The Context: Review Of The Report “Accelerating Access For Patients
To Best Medicine: The System And The Challenge” And Subsequent Findings .... 10
  3.1.   Chair: André Potworowski .............................................................................. 10
  3.2.   Speaker: George Wells .................................................................................... 11
  3.3.   Speaker: Monique Bégin.................................................................................. 12
  3.4.   Speaker: Judy Erola ......................................................................................... 12
  3.5.   Chair : André Potworowski ............................................................................. 12

4.      Clinical Trial: Benefits To Patients And The Health Care System................... 12
     4.1.    Speaker: Paul Hébert........................................................................................ 12

5. Canada’s Biopharmaceutical Pipeline: Forecasting Canada’s Clinical Trial
Activity ............................................................................................................................. 12
  5.1.     Speaker: Ken Lawless...................................................................................... 12

6. Panel Discussion: The Patient Perspective: What Patients Want And Don’t
Want From Clinical Trials: Monique Bégin, Deanna Silverman, Donna Marcelissen
     13
  6.1.  Chair: Monique Bégin...................................................................................... 13
  6.2.  Speaker: Donna Marcelissen (patient) ............................................................. 13
  6.3.  Speaker: Pat Froio (Canadian Cancer Society)................................................ 14
  6.4.  Speaker: Deanna Silverman (Patient) .............................................................. 14
  6.5.  Questions and Answers for the above panel:.................................................... 15

7.      A Private Research Clinic as a Management Model ........................................... 16
     7.1.   Speaker: Pierre Gervais.................................................................................... 16

8.      Questions and Comments....................................................................................... 16

9. The Current And Future Situation Of Clinical Trials And Clinical Research In
The Ottawa Hospital....................................................................................................... 16
  9.1.  Speaker: Ron Worton....................................................................................... 16

10.     Patiently Crossing The Intersection At Industry And Academia .................. 17
  10.1.      Speaker: George Wells ................................................................................ 17

11.        Breakout Groups................................................................................................. 18


                                                                                                                                       5
     Group 1: ........................................................................................................................ 19
     Group 2: ........................................................................................................................ 20
     Group 3: ........................................................................................................................ 21
     Group 4: ........................................................................................................................ 22
     Group 5: ........................................................................................................................ 23
     Group 6: ........................................................................................................................ 24
     Group 7: ........................................................................................................................ 25
     Group 8: ........................................................................................................................ 26

12.     Summary: ............................................................................................................ 27
  12.1.    Speaker: François Bertrand.......................................................................... 27
  12.2.    Speaker: Ron Worton................................................................................... 27
  12.3.    Speaker: Monique Bégin.............................................................................. 27

FEBRUARY 11, 2005 .........................................................................................28

1.      Opening:................................................................................................................... 28

2.      The Dublin Molecular Medicine Centre:.............................................................. 28
     2.1.   Speaker: Pierre Meulien................................................................................... 28

3. Panel Discussion: What Does Industry Want Out Of An Ideal Clinical
Research Site ................................................................................................................... 28
  3.1.  Chair: André Potworowski .............................................................................. 28
  3.2.  Speaker: Nestor Nituch (Bristol-Myers Squibb Canada)................................. 29
  3.3.  Speaker: François Le Barbenchon (Covance Canada Inc.) ............................. 29
  3.4.  Speaker: Ken Newport (PRA International) .................................................... 29
  3.5.  Speaker: François Bertrand (Merck Frosst)..................................................... 30
  3.6.  Speaker: Sven Blumenstiel (IBM) ................................................................... 30
  3.7.  Questions and Comments: ................................................................................ 30

4. CIHRs Clinical Research Initiative – Transforming Canadian Clinical
Research Capacity For The 21st Century ..................................................................... 31
  4.1.  Speaker: John Cairns........................................................................................ 31

5.      A Model That Works: The Ontario Cancer Research Network ....................... 31
     5.1.  Speaker: Robert Phillips (Ontario Cancer Research Network)........................ 31
     5.2.  Speaker: Ray Saginur (Ottawa Hospital Research Ethics Board) ................... 32

6.      A New Paradigm For Drug Development In Canada.......................................... 32
     6.1.   Speaker: Robert Peterson (Therapeutic Products Directorate, Health Canada)
            32

7.      Improving Governance And Contracting Procedures For Clinical Research .. 32
     7.1.   Speaker: Rob Hanlon (OHRI).......................................................................... 32
     7.2.   Speaker: Nestor Nituch (Bristol-Meyers Squibb)............................................ 33




                                                                                                                                       6
8.      Panel Discussion: How Can Regional Hospitals Collaborate? ........................... 33
     8.1.   Chair: Ron Worton (OHRI) ............................................................................. 33
     8.2.   Speaker: David Moher (CHEO)....................................................................... 33
     8.3.   Speaker: Larry Chambers (EBRI -- Elisabeth Bruyére Research Institute) .... 34
     8.4.   Speaker: Brian Malcolmson (Monfort)............................................................ 34
     8.5.   Speaker: David Crowe (Queensway-Carleton Hospital) ................................. 35
     8.6.   Speaker: Zul Merali (Royal Ottawa Hospital) ................................................. 35
     8.7.   Speaker: Rob Roberts (University of Ottawa Heart Institute) ......................... 35
     8.8.   Questions and Comments: ................................................................................ 35

9.      Centre for Applied Health Research: ................................................................... 36

10.   Breakout Groups: ............................................................................................... 37
  Group 1: “Relations Between the Sites and the Sponsors”.......................................... 37
  Group 2: “Regional Ethics Board and Facilitating Contracts” .................................... 37
  Group 3: “Issues of Training”...................................................................................... 38
  Group 4: “New Paradigm”........................................................................................... 39
  Group 5: “Leadership, Funding, and Governance Structure”...................................... 40

11.     Conclusion and Wrap-Up: ................................................................................. 40
  11.1.     Speaker: Paul Hébert.................................................................................... 40
  11.2.     Speaker: Judy Erola ..................................................................................... 41
  11.3.     Speaker: Ron Worton................................................................................... 41
  11.4.     Chair: Monique Bégin.................................................................................. 41

12.        List of Speakers:.................................................................................................. 42




                                                                                                                               7
Key Conclusions from Conference
on “Building Excellence in Clinical Research and Clinical Trials”,
Ottawa, February 10-11.


These are the issues and challenges which were raised at the conference, which
we need to prioritize and address as a regional group.

Academic-Industry relations
• Develop socially and ethically responsible frameworks for partnerships
  and collaboration between university and industry (pharma, biotech, medical
  devices).
• Explore new ways of partnering with industry, and academia
• Anticipate and adapt to new paradigms of drug development, e.g.
  pharmacogenomics, targeted drugs, smaller trials: social, ethical and
  infrastructure challenges
• Improve collaboration between sites, sponsors, and investigators
• Become more responsive to industry needs, e.g. Accurate prediction of
  patient enrolment

Regional Capacity Building
• Make voice of region heard nationally in new drug development process
• Facilitate more C-Trials and C-Research in Ottawa region
• Ensure a viable place for Canada and Ottawa Region in light of world
  growth in CTs, of 400% in South America, and 2000% in Asia
• Find a niche for CTs in Ottawa – Build on strengths – Paediatric, cardiac
  trials and differential advantages – such as low migration, excellent long-term
  follow-up and data quality.
• Help community hospitals strengthen links between small players and
  experienced researchers, e.g. help Monfort Hospital build up its research
  capacity
• Develop Cross-Champlain studies, e.g. obesity & diabetes

Patients
• Ensure voice of patients are heard more clearly in CT and CR enterprise
• Think regionally (Champlain) in terms of patient recruitment, engage
   patient population – have better access to region’s patient population
• Better capture and publicize region’s patient demography
• Publicize all trials in the region, easy to access by patients



Infrastructure, approval and speed
• Improve speed of approval: ethics, consent, contracts


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• Help regional hospital with new & better contracting and approval
  processes
• Develop regional ethics board, fast, reliable, high quality, trustworthy
• Develop regional infrastructure for CTs, including methods platform
• Training – more nurses, clinical researchers. Make time and money
    available

Umbrella Issues:
• Create “Interim Steering Committee”, with a secretariat or part-time
  coordinator.




J. André Potworowski, Feb 24, 2005




                                                                             9
                            February 10, 2005

1. Introduction

  Speaker: The Hon. Judy Erola PC

     Ms. Erola opened the conference, welcomed all the guests, participants
  and speakers, and emphasized that the purpose of this conference is to have
  a goal by tomorrow, to draft a blueprint for a centre in Ottawa, and to turn a
  dream into a reality.


2. Opening Statement

  Speaker: Dr. Peter Walker, Dean, Faculty of Medicine, University of
  Ottawa

      Dr. Walker indicated that he has reservations about where these
  discussions can go. He mentioned that the group attending the conference
  has a social and ethical responsibility that it must fulfill. There are several
  areas that he is concerned about, such as placebo based trials, that new or
  regenerated agents often give little additional benefit, that there are often
  weak relationships between industry and academia, and that often trial
  results cannot be disclosed due to contractual relationships.

     Dr. Walker is concerned about controversy because research is publicly
  funded and should therefore be considered an open source but contrary to
  that, there is also pressure for secrecy due to companies wanting a
  competitive edge. As well, money often goes to marketing in lieu of
  pharmaceutical research. With regards to academia and the pharmaceutical
  industry, neither can exist without the other and therefore should be able to
  work together. He suggests that perhaps an arms length organization should
  regulate them such as regional ethics boards. One final suggestion Dr.
  Walker gives is that all the data from clinical trials must be collected and
  reported, as the most critical reason for doing this is to act on behalf and for
  the best interest of the public.


3. Setting The Context: Review Of The Report “Accelerating Access
   For Patients To Best Medicine: The System And The Challenge” And
   Subsequent Findings

  3.1.   Chair: André Potworowski



                                                                                    10
       Dr. Potworowski noted there is no study that demonstrates the side
   benefits of clinical trials, other than prove the efficacy and safety of drugs .
   These ancillary benefits must be demonstrated and linked to a broader
   picture. He points out that there is a need to make a valid business case for
   a national strategy on clinical research in order to increase investment and
   patient benefit.x

       Dr. Potworowski set the stage for today’s presentations by posing the
   following questions: what are the risks and benefits of clinical trials, what are
   the most important steps in CTs, and what are the best practices that we can
   learn from others in Canada? He presented the results of a key study carried
   out by Monique Bégin, Judy Erola, George Wells, and himself, which led to
   this Conference.


          Click here to download André Potworowski’s PowerPoint presentation
   (105 KB)
          Click here to download all presentations in ZIP format (50 MB)



   3.2.     Speaker: George Wells
                     (refer to Potworowski’s slide presentation)

   Dr. Wells, as part of the above study, interviewed researchers with respect to
three different areas: industry, biotech, and IRB’s. He had the following to say
about each.

   In industry, opinions are split. The resources are where the large
pharmaceutical companies are, but there was a general concern over the central
question. He was concerned about the young researchers. The overall feeling of
the interviewees was that the large pharmaceutical companies were ethical and
that company culture was very important.

    In biotech, there was feeling that they can be prosperous but lack a lot of
resources. Another issue is that there is a tendency to micromanage where
there is expertise. They also generally have a small budget and a small product
line and often do not understand what academia can do for them. With this in
mind, there can be a lot of value added for biotech with the clinical trials.

   One comment about IRB’s is that there is concern with lack of national
standards, which often is associated with conflicting results.




                                                                                  11
   3.3.   Speaker: Monique Bégin

   Monique Bégin has interviewed 15-20 patients who are active in support
groups. The patients expressed that they want faster access to clinical trials.
They also were concerned that often their family physician is left out of the loop
during clinical trials and that as a patient, they don’t see the results of the study.
There is confusion on the part of the patient because they see the modern world
as being global, yet as a country, we seem unable to make alliances with other
countries with similar standards to ours, with a view to speed up the regulatory
process of drug approval.

   3.4.   Speaker: Judy Erola

    Ms. Erola indicated that she felt that there is growing sophistication amongst
the patient population because they express concern about the lack of
information about clinical trials. They are frustrated with lack of access to results
in the trial in which they participated in and they are frustrated with not being
involved in the initial stages in clinical trials. Overall, there is a strong support
for clinical trials by patients, not necessarily to benefit the individual patient, but
the patient body as a whole.

   3.5.   Chair : André Potworowski

     Dr. Potworowski mentions that there has to be movement towards an action
initiative. The challenge is as what Peter Walker mentioned; what types of
systems to put in place? The skills are here in Ottawa and our job is to listen
carefully and participate in the breakout groups.


4. Clinical Trial: Benefits To Patients And The Health Care System

   4.1.   Speaker: Paul Hébert

   Paul Hébert was definitely in favour of clinical trials and put together a good
case for the benefits and the essentiality of clinical trials in medical care.

    Click here to download Paul Hébert’s PowerPoint presentation (105 KB)


5. Canada’s Biopharmaceutical Pipeline: Forecasting Canada’s Clinical
   Trial Activity

   5.1.   Speaker: Ken Lawless




                                                                                    12
    Ken Lawless was in favour of clinical trials. From the biopharmaceutical
viewpoint, there was a great need for these trials. For example, with 435
biopharmaceuticals waiting for clinical trials, there is a commercial gap in the
infrastructure that needs to be bridged. Since implementation of any plan takes
time, Ken felt that “time was of the essence”.

    Click here to download Ken Lawless’ PowerPoint presentation (26.8 MB)


6. Panel Discussion: The Patient Perspective: What Patients Want And
   Don’t Want From Clinical Trials: Monique Bégin, Deanna Silverman,
   Donna Marcelissen

   6.1.   Chair: Monique Bégin

       Clinical trials do not exist without patients. They are the core of the
   clinical trials. Today, we have one voice for cancer and one voice for
   diabetes. The other diseases are not represented here at this time. It is not
   easy for patients to move from private life to private to public life and share
   their inner experiences with strangers, so their presence here with us is
   greatly appreciated.

   6.2.   Speaker: Donna Marcelissen (patient)

       Donna was diagnosed with diabetes at the age of 17. In total, she
   underwent over 20 eye surgeries, lost the ability to digest food, and suffered
   from hypoglycaemic unawareness. Donna was the first participant from
   Eastern Ontario for an islet transplant study in Edmonton. (A CBC video clip
   of a synopsis of Donna’s life with diabetes, with scenes from transplant
   surgery is shown.) She underwent two transplants, the second being a “top-
   up” transplant of islet cells into her liver. Post-transplant she was free of
   exogenous insulin, achieved euglycaemia and witnessed a reversal in some of
   the complications. Anti-rejection drugs are life-long, but the transplant has
   saved her life. She is here today as an advocate for research and clinical
   trials. Donna has written a book detailing her role in the world renowned
   Edmonton Protocol as a patient and research participant (One Step Up From
   a Lab Rat). For 16 months post- transplant she was free of exogenous
   insulin, but has recently had to return to small amounts. She feels that the
   research protocol was a success and states that “everything is not perfect,
   but life is so much better”.

      As far as finding information about research and the types of clinical trials
   that are taking place, it is very difficult. Donna found the information
   regarding the islet transplant from a short news clip and searched


                                                                                 13
painstakingly on the internet to locate the doctor that was doing the
research.

    Donna mentioned that the financial commitment involved with this clinical
trial (conducted in another province) was enormous. The housing,
transportation and drug costs were over $30,000. When she returned to her
home province the drug cost was not covered by health insurance and were
exorbitant.

    Donna’s doctor, Dr. Shapiro (Principal Investigator), and the research
team at Alberta’s University Hospital made her feel like she was an integral
part of the study. As part of the protocol, the nurses remain in touch with
recipients.

    Donna is an advocate and supporter for organ donation and diabetes
research through the Juvenile Diabetes Foundation as a
testimonial/motivational speaker.

6.3.     Speaker: Pat Froio (Canadian Cancer Society)

    Pat is a former teacher from the Hamilton area and is now an information
specialist for the Canadian Cancer Society. Her job focuses on a cancer
information service for the public. She gets questions mainly from patients
and their families, the general public, and from health-care professionals.
When patients call, they usually are newly diagnosed and are seeking
information about cancer and the treatment regimen. Some of the questions
she gets pertain to current cancer treatments, new drugs or new treatments
profiled in the media, and information on research and clinical trials. These
days, people are more proactive and look for information on research and
clinical trials. When they do, she directs them to clinical trials databases such
as NCIC and OCRN.

    There are callers who have been approached by their doctor to participate
in clinical trials. These leery patients are curious to seek more advice or a
different opinion on that option. Pat answers their questions about clinical
trials as well as directs them to a peer referral service. Here, patients can be
in contact with patients who have gone through similar experiences. It
provides the benefit of cancer patients sharing experiences and giving
support on cancer treatment and clinical trials.

       Click here to download Pat Froio’s PowerPoint presentation (203 KB)

6.4.     Speaker: Deanna Silverman (Patient)




                                                                               14
    Deanna is a 16-year breast cancer survivor from Kanata. She described
her clinical trial experience as including a cocktail of drugs that posed
horrendous side effects that were not in “the book”. Deanna underwent
heart tests before and during the treatment. The first treatment had reduced
her heart muscle so much that a second treatment was denied. She was
then placed in the second arm of the clinical trial which involved much higher
doses of the standard breast cancer chemotherapy cocktail. Though the side-
effects were again severe, Deanna was able to stay in the trial and complete
her treatment.

   For the last 14 years, Deanna has been a patient voice. She advocates
that focusing on the patient is very critical to the success of the trial.
Understanding that “each patient is unique with unique needs” is key. It is
important to remember that the patient and the family are fragile at that
particular moment in time when they are in need of the trial. Presently there
seems to be a lack of focus on the patient. They need psychological, social,
and spiritual needs met right from the beginning.

    Deanna mentioned that studies show that more patients choose to be
more aggressive than less aggressive in their treatments. The patient wants
to live and is willing to take the risks if the information is presented to them
in the right way.

    In a summary, Deanna presented what patients want from clinical trials.
From the medical side, they include: a holistic approach, want to know the
options and acknowledgement of the reality of what is happening,
reassurance that there is patient involvement, public reporting of both the
positive and negative results, know the gold standard and care options, and
the potential benefits and risks. From the more personal side, they want to
know “why me?”, they want all questions answered fully, directly, completely,
and honestly, they want time to absorb and consider what they have been
told, they need a degree of flexibility, they need a system of group support
from other patients, and after the trial they want a “thank you” for being
involved.

    What patients don’t want from clinical trials is to worry that they will
further endanger their lives, have additional hardships, and be alone (without
a support system). They want a patient voice to protect their interests and to
have a voice at all levels of the clinical trials.

6.5.   Questions and Answers for the above panel:

Q. Would you like to see more clinical trials in the Ottawa region?
A. Yes


                                                                              15
   Q. What is the best way to communicate with the patients?
   A. Through media
   A. Having the doctor involved in the clinical trial personally call the patient
      directly at home.

   Q. What would make it easier and take less time to sign a consent form?
   A. Give the patient a copy of the consent form to take home.
   A. Have someone take the time and go over it with the patient.


7. A Private Research Clinic as a Management Model

   7.1.   Speaker: Pierre Gervais

   Dr. Gervais addressed his criteria for a successful research clinical model.
There were 6 key elements that he felt were important and lists the issues under
each element that he deemed necessary for success.

   Click here to download Pierre Gervais’ PowerPoint presentation (134 KB)

8. Questions and Comments

The following were comments raised by the floor during the reflection of the
morning’s discussions:
          - Trials should not do more harm than good
          - There should be post-marketing surveillance as there is risk for a
             company to be sued in court. Field testing is also important
          - What changes in the regulatory system in the US will need to be
             done?
          - Who will do the post-marketing study? A private company?
          - Recruiting without the holistic approach has proved to fail in the
             sense that people drop out
          - There should be internal audits. Done worldwide by FDA.
          - Chose more academic centres, even on a global scale where
             demographics pose less a problem.

9. The Current And Future Situation Of Clinical Trials And Clinical
   Research In The Ottawa Hospital

   9.1.   Speaker: Ron Worton

      Dr. Worton took on a regional approach to clinical research. He believes
that we have to look for opportunities across the region. There are more than


                                                                                     16
six hospitals in the region that can benefit if they work together as there is
access to a larger pool of patients, continuity of care across the region,
collegiality, and patient convenience. The Ottawa hospital undertakes a special
role because it has a large academic health science centre, a substantial research
institute, a clinical epidemiology unit, as well as existing current clinical trial
activities (about 1200 in all), and a strong research ethics board.

       There are about 1200 clinical trials currently running. About $17.5 million
is spent in clinical research annually, which has been constant over the last four
years. About 60%-65% is investigator driven research and about 35%-40% is
industry-initiated research.

       In the top 20 clinical trials, 19 of them are investigator driven and only
one is industry driven. All these trials tend to be multi-institutional and long-
term in nature. Some involve Atkins & Friedman (MS society), large HIV
treatment groups, cardiac surgery, Ian Steel’s work in improving resuscitation,
and Ron Segal’s studies on exercise with patients with diabetes such as
teenagers and exercise and their quality of life.

        Dr. Worton feels that there may be a possible niche with children and
clinical trials.

10.    Patiently Crossing The Intersection At Industry And Academia

   10.1. Speaker: George Wells

       Dr. Wells reviewed the fact that in the beginning, industry needed
academia to perform clinical trials and academia needed industry for research
and clinical purposes. Things have changed since then and now industry is less
dependent on academia, as they employ top-level researchers, they are
frustrated with academic medical centres, and they turn to the commercial sector
with key players. Academia has a less favourable view of industry for research
as they have business interests such as stockholders, there are financial
incentives that may create a conflict of interest, the research may be subject to
methodological bias, and the publications may be subject to reporting bias.

        Dr. Wells expressed the need to restore the balance. On the financial
side, there are the investigator’s financial conflicts of interest with industry and
publication bias and there are issues with bias on the methodological and
reporting side. He mentions the Schulman et al survey (NEJM 2002) and its
purpose to determine if research at academic institutions adheres to the new
guidelines.




                                                                                       17
         Dr. Wells stated that there has to be agreement as to the design of the
trial, the access to data, and the publication of results. He concluded by saying
that “somewhere along the line the two (academia and industry) and going to
meet”.


11.   Breakout Groups


Question: Do we want more clinical trials in the region? If so, should they be
industry-sponsored or led vs. peer-clinical research or investigator-sponsored,
and what should be the balance?




                                                                                18
Group 1:

Yes, there should be more trials.

Appropriate balance?
          - Balance is not important – need guidelines to manage
Barriers:
          - Apathy amongst practicing clinicians
          - Ethics boards
          - Regional – all eggs in one basket
          - Become too bureaucratic compared to current private
          - Independent
          - Experts in the field
          - Timely, efficient – not dysfunction, performance evaluation,
              administrative resources, proper remuneration
Resources:
          - Properly trained personnel
          - Proper infrastructure
          - Regional common contractual template
          - Websites
          - Formalization of a network
          - Improving awareness/communication amongst patient groups and
              clinicians
          - Regular meeting of investigators and stakeholders – recruitment and
              collaboration
Q/A:
   Q. How difficult was it to come to a consensus?
   A. It reflected the feelings of the group
   A. Tried to promote academic interest in the group
   A. Establishing a network is important




                                                                            19
Group 2:

Yes.
Most important things are: good partnerships and understanding

Balance?
           There should be a balance, but exact balance is determined by various
           -
           factors, depending on where research is taking place
Other comments:
         - Research ethics boards – needs for faster process
         - Trained researchers are important
         - Pockets of specialities need to be brought together
         - Space is an issue for research
         - Support structure
         - Increasing funding
         - Review and approval – template is important
Barrier:
         - Number of patients and where they are coming from is important

Q/A:
   Q. Why is increasing the number of clinical trials good?
   A. Better patient care.

Comments:
        -      Need to build a clear business case, as right now there is no business
               case
           -   There are clear models, but no clear business case; economic models are
               there (in New York, for example); opportunities to build models are also
               there
           -   Getting better at running clinical trials; better at designing them and
               finding the right answers
           -   Better patient care – recruit doctors for studies – opportunity for good
               and consistent care during a study and often the doctor becomes their
               family physician after the trial




                                                                                    20
Group 3:

Yes.
Not just because of patient care.
There is a need to have guidelines or a template so that people feel comfortable.
Have to have some kind of stratification guidelines and how they would impact.

Ethics boards, regionalization, are helpful.
So many steps necessary.
Frustration about ethics.
Placebo based trials.
Defining things that would not make it difficult.
Understanding needs of clinical scientists would be important

How to do clinical trials?
         - Having mentors to teach medical students should be actively pursued
         - Would publication rights attached to clinical trial would be respected if
              part of a multi-clinical trial? (queen bee analogy)

Patient involved in clinical trial:
           - Is the info shared with the person’s family physician?
           - Some patients may not want it to be shared, but most of the time it is
               shared

Q/A:
   Q. Can the primary physician be much more proactive? I he/she linked to the
      necessary resources? Generally it is the specialist who did the enrolling.
   A. Feeling that there can be more of a role with family physicians. Not always
      good at telling what the summary result of the trial is. This would increase
      awareness very much. A “warm fuzzy” with the physician will encourage the
      physician to send more possible clients to the study.
   A. Agreement with previous. Due to workload, many family physicians do not look
      at the messages or reply to them. Some are afraid to give up patient.
   A. Oncologist example. Build network and visit primary care physicians. Site
       selection. Get the physicians that are involved and network.




                                                                                    21
Group 4:

Be careful about addressing this. Question about quality. Do not look at number, but
quality of trial. Are we making a significant contribution to that trial? Ways to make
contribution are groups of researchers to get together.

Comments:
        −    Work with private sector to build that research up.
        −    Patients being at the centre. Provide better patient care.
        −    Common themes for obstacles: funding—grants, industry
        −    Science. Good ideas, but may be a lack of expertise.
        −    Infrastructure support is an ongoing issue.
        −    Time to approval is long. Can we have more of a provincial board?
        −    Communication: to patients, administration
        −    Culture: trials are part of the treatment, not an extra
        −    Solutions: Collaboration between academia and industry
        −    Regionalization
        −    Capitalize on areas of strength
        −    Consortium
        −    Education of investigators, administrators, patients, public (ongoing
                  issue that not enough time is spent on)

Q/A:
   Q. Is the clinical trial an “add-on”?
   A. Haematologist’s reply: drugs in hospital are not charged for, but given in
      clinical unit, it is an added cost. This makes them less competitive than other
      centres. This is an issue!
   A. Cramped for space for a cancer centre. If it is a trial, consensus is resources
      are not available for normal treatment, let alone research

   Q. André: What kind consortium of would benefit the region the best?
   A. All the “brains” should be utilized
   A. Pool common research interests.

   Q. André: Are there horizontal issues that would make the region as a whole?




                                                                                     22
Group 5:

Yes.

Comments:
        -        More trials are a good thing.
        -        Better care, access to new meds/technologies.
        -        Establish standards of care.
        -        Studies have shown that with patients on clinical trials, overall costs to
                 the health care system are reduced.
Balance:
             -   Need to build a better infrastructure

Obstacles:
          -      REBs and contracts (symptoms), lack of pool of trained research
                 associated—study closes that person is out of work, another research
                 associate is needed, trained again, etc.
             -   Lack of trust and lack of commitment at a regional level.
             -   Turf protection. (symptoms)
             -   Unwillingness to share expertise.
Solutions:
             -   $$
             -   Standards and guidelines

Q/A:
   Q. How does paediatrics fit into a model that is adult based?
   Q. Can they fit into a regional model, or a subset?




                                                                                         23
Group 6:

Yes, do want more trials. Better, but not necessarily more.

Obstacles:
          -    REB issue – sometimes difficult and lengthy to get approval
          -    HR – skills and experience are not always available to participate
          -    Participation by family physicians – referrals, how to make it attractive
               for physicians to refer
           -   Time to contract – dealing with lawyers
           -   QA and resources for doing good quality studies
           -   Use of IT and its availability
           -   Adverse event reporting and large volume of paperwork was an
               obstacle
           -   Patient awareness
           -   PIPEDA – costs implied in this.
           -   Insurance – studies run from Ottawa, but run internationally, may not
               be insured.
           -   Patient data and protection of data after the study is finished
           -   Post study treatment and availability of drugs.
           -   Bias against these types of studies.

Solutions: no time

Q/A:
   Q. Is the government going to run the post marketing surveillance? Or just
      expect it? Who will pay?
   A. Mandated by government, but will not pay for it.
   A. There is movement underway




                                                                                      24
Group 7:

Yes. Participation needed for many communities of interest in the region.

Comments:
        -      Need to get info out to the community and health care system as well.
        -      Quantify the balance – industry sponsored trials are not bad.
        -      Trials may be used to generate money for other trials.
        -      Do we have the infrastructure now to increase our Phase 1 now?
        -      Regulations – important that we need to increasingly adhere to
               international regulations
           -   Make Ottawa attractive to international investors
           -   Do a cost comparison.
           -   We have to market (aggressively) our want for involvement.
           -   Cost analysis for conducting trials.
           -   REBs and their capacity and workload they will be facing.
           -   Look at the move towards a regional REB.
           -   Commercial REBs have a role?
           -   Capacity and overload – look at for the region
           -   If increase capacity, need to make the region look attractive.
           -   HQP are needed.
           -   Focus also on diagnostics




                                                                                  25
Group 8:

Yes – there should be more. But more is not necessarily better.

Group Comments:

           -   Balance is a complex problem. Should be a balance. There will always
               be some tension between the two. Important to know that industry
               have different views. Very important questions. Needs to be clinically
               relevant. More research. How? Biostatisticians need to be involved so
               that the info can flow. Need for them.

           -   Multi-centred trials. Ottawa, Pembroke, Deep River. Into our local
               region. Getting a busy physician involved is difficult and needs to be
               worked out. AFPs are the norm. Amount of $$ paid for research should
               be increased. Need to look at all the disciplines. Resources for the
               Phase 2 & 3 trials are necessary.

           -   What will be the role of CHEO?

           -   Uncharted territory. Don’t want to take risks with kids. More pathology
               in adults than kids. Need to be aggressive in standardization in
               research. Yes, should try to integrate as much as possible. Should not
               be an island unto itself.

           -   Value of clinical research in children. From 50% to 90% survival due to
               research. Kids will grow up and be contributing members to society is
               not measurable.

           -   Problem with paediatric is: paediatric diseases are interesting to study.
               Getting patients and trials is not the problem. Trying to find methods
               less toxic is the problem.

           -   The FDA grants an extended time in patents for drugs that have trials
               in kids.

           -   Drugs made for adults being used on kids.

           -   Hard to get approval from parents




                                                                                     26
12.   Summary:

   12.1. Speaker: François Bertrand

    Dr. Bertrand summarized that he sees a uniform agreement for a need or
want for more clinical trials. Even so, there are many issues such as training,
qualified personnel, lack of trust, and numerous differences in the cultures that
have to be worked out. There is competition on a global basis because,
relatively speaking, Canada is a small country. Canada needs to attract more
studies and in order to do this it has to become more competitive. There are
issues with under-funding and mechanisms have to be put in place for increases.
Guidelines must be standardized. The IRBs and Health Canada are part of that.
Capacity is an issue. Do we know our capacity? Quality is an issue. And finally,
patients are not aware of the clinical trials.

   12.2. Speaker: Ron Worton

    Dr. Worton felt that there are major issues that need to be addressed. There
is a huge quality of research talent in Ottawa that can be capitalized on. As the
biotech industry grows, focus should be placed on local research. There is a
need for patients to be centred in a clinical trial and have their emotional and
spiritual needs met. There exist different purposes for industry and academia,
but both are very good. Feelings were voiced that research ethics boards were
part of the problem because they have been overloaded and understaffed; yet
this is not always the case. Dr. Worton warned against using ethics boards as
scapegoats. He mentioned that communication should be addressed rather than
more resources. There is a need for more standardized SOPs. He suggested
specialized research boards. He raised a flag about insurance because you are
not covered if you are sued outside the country.


   12.3. Speaker: Monique Bégin

    Mme Bégin felt that this was an enriching day with a special type of
interaction. She posed a question that stated “what is it we want to
communicate at the end of the two days?”. She added that this region has been
very fragile due to the restructuring of the region a few years ago and that
leadership is trying to overcome a difficult and divided past and that we should
decide on some type of commitment inside this room. She liked this day and
how it turned out with its enormous amount of commitment to change.




                                                                               27
                             February 11, 2005
1. Opening:

Chair: Monique Bégin

       Monique recapped yesterday’s question: “Do we want clinical research in
our region and more of it?” and answered it with a “yes”. She indicated that
today’s focus will be to move towards what should become one day a firm
commitment and suggested a change to today’s agenda by introducing a visiting
guest from Dublin.

2. The Dublin Molecular Medicine Centre:

   2.1.     Speaker: Pierre Meulien (CEO, The Dublin Molecular Medicine
          Centre, Ireland)

       Dr. Meulien mentioned that he would go back to Dublin and suggest the
same type of forum as presented here and reflect on some of the issues that
were looked at.

       He was brought up in Dublin, where there is a large pharmaceutical
presence. Currently, his job is to take the academic tradition and get three
medical schools to work together. This would be the first time in 400 years that
they made a strategic plan. He expressed that the top down approach does not
work in Ireland and that education programs are key to success. It is important
to bring people together into a non-threatening environment in order to work
together and learn. He indicated that it is a huge challenge to have a goal and
that we need to work together to move forward.

       Dr Meulien concluded my summarizing his thoughts from yesterday. He
indicated that it is important to create a model that works for you, create
benchmarks, focus on niche areas, and decide what you are good at and focus
on that.

   Click here to download Pierre Meulien’s PowerPoint presentation (764 KB)

3. Panel Discussion: What Does Industry Want Out Of An Ideal Clinical
   Research Site

   3.1.     Chair: André Potworowski

      Dr. Potworowski mentioned that the first SOCRA meeting will be on
March 8 at 4pm at CHEO and that there is a sign up sheet available.


                                                                               28
   3.2.    Speaker: Nestor Nituch (Bristol-Myers Squibb Canada)


       Mr. Nituch expressed concerns on how to organize the clinical trials, as
organizations are always changing and moving. He gave his views on what he
sees as an ideal clinical trial site (refer to slide presentation). In Mr. Nituch’s
view, experienced personnel are needed to negotiate contracts, as lawyers do
not understand the medical/pharmaceutical world. And finally, he gave
indication that reasonable and attainable estimates of patient recruitment must
be made and that timelines were critical.

      Click here to download Nestor Nituch’s PowerPoint presentation (17 KB)

   3.3.    Speaker: François Le Barbenchon (Covance Canada Inc.)

        Mr. Le Barbenchon mentioned that a CRO works with pharmaceutical and
biotechnology companies to help them with their drug approval process and
move it forward. The “site” is the centre of the universe where enrolment takes
place. This is crucial. There is a need to look at design, packing & shipping of
supplies to the site, and monitoring of the site. Data flow and report analysis is
the final step. The site performance should be economically driven. Mr. Le
Barbenchon reviewed five factors affecting the country and site selection (see
slide) and the demographics involved. He talked about the treatment practices,
past site performance and variability, logistics and variability, effort vs. yield,
investigator feedback, and current competition.

      Click here to download François Le Barbenchon’s PowerPoint presentation (436
KB)

   3.4.    Speaker: Ken Newport (PRA International)

        PRA is one of the largest international organizations and they tend not to
go into smaller trials. There are three main criteria that get PRA’s attention: 1)
quality, 2) cost, and 3) speed. Mr. Newport felt that most sites want to go for
quality and in most large international trials, quality is either there nor not there.
For the most part, Canadian sites always have quality yet it is rarely a concern,
but neither a distinguishing thing either. As for cost, it is rarely a distinguishing
feature either. Speed is the most important. Speed can easily be traded for cost
and in a global perspective, Mr. Newport said that it is hard to win on cost alone,
so speed seems to be the only reasonable option. Mr. Newport feels that it is
difficult to get through start-up. One hurdle is that recruitment is difficult as
large volumes are needed and timelines are important. He feels that we need to
focus on speed as this is what will differentiate us.


                                                                                     29
   3.5.   Speaker: François Bertrand (Merck Frosst)

        Dr. Bertrand mentions two ways to achieve partnerships: 1) ask a site to
participate (which is the most common option) or 2) sit down with a site and find
out what their areas of expertise are. He feels that we have to look for potential
alliances, identify the areas of strength, collaborate and work together and form
a true partnership.

      Click here to download François Bertrand’s PowerPoint presentation (31 KB)

   3.6.   Speaker: Sven Blumenstiel (IBM)

Mr. Blumenstiel believes that a huge change in the industry is necessary. He
strongly believes that the medicines that we have today will evolve into more
specific drugs but with this comes a certain level of partnership needs. Clinical
development is very expensive and often unaffordable. A different model has to
be accepted rather than the usual phase I, II, III, etc. Technology has to play a
big role as well.

      Click here to download Sven Blumenstiel’s PowerPoint presentation (2.4 MB)

   3.7.   Questions and Comments:

Comments:
  - agree with quality and speed, but have some concerns; would like to see
    more flexibility in language
  - changes in CRA’s is important for continuity
  - need for sponsors to listen to experts, especially in a field they are not too
    familiar with
  - queries are very expensive and take a lot of time
  - concern with everyone working together
  - there is a need to speed up contracts
  -

Q. what additional criteria would be important in an academic health centre?
   What value added is there?
A. time and place – speed is normally an issue, but is not always feasible

Q. there is a need for the academic community to come together, but how can
    industry come together to help academics?
A. The British have come up with a template. We are not sure if the British
    model would work for Canada, but would welcome any way we can get this
    done.


                                                                                   30
4. CIHRs Clinical Research Initiative – Transforming Canadian Clinical
   Research Capacity For The 21st Century

   4.1.   Speaker: John Cairns

       Dr Cairns addressed the group with a reminder that clinical research is
that part of the continuum of health research which is conducted on human
subjects. Clinical research combines discoveries from the basic science laboratory
with the observations and insights of clinicians (translational research). It
develops potential preventive, therapeutic and diagnostic measures and
evaluates their effectiveness for improving health. None of this new knowledge
has practical value unless it can be applied in the health care system (knowledge
translation). In a quick summary, Mr Cairns addressed the question as to why
we need to strengthen clinical research in Canada, the good opportunities for
Canada to be an international leader, and the need to overcome Canadian
weaknesses. He outlined three strategies for strengthening clinical research . He
went on to describe three types of required national infrastructure for clinical
research, including possible numbers and national distribution. In closing, he
drew attention to the major initiatives being undertaken to strengthen clinical
research in the US and the UK, and the implications for Canadian planning.

     Click here to download John Cairns’ PowerPoint presentation (1 MB)


5. A Model That Works: The Ontario Cancer Research Network

   5.1.   Speaker: Robert Phillips (Ontario Cancer Research Network)

       Dr. Phillips began by stating the mission of the Ontario Cancer Research
Network: “To accelerate promising new cancer therapies and to stimulate R & D
in Ontario”. He added that we needed to recognize that new molecules have
industry involvement and that there is a strong commercialization influence on
research.

       Dr. Phillips belongs to a new not-for-profit organization located outside of
government that has funding through MEDT. He advised that new infrastructure
has to be self-sustaining and that revenue must be generated internally.
Ultimately, the programs must not have an adverse effect on patient care. He
took us through the principles, strategies, and programs relating to clinical trials.
See his slide presentation for details.

      Click here to download Rober Phillips’ PowerPoint presentation (1.3 MB)




                                                                                   31
   5.2.     Speaker: Ray Saginur (Ottawa Hospital Research Ethics Board)

      Dr. Saginur admits that his office is frequently seen as an obstruction, but
we must be aware that there is a social value to research ethics boards and that
there must be a working collaboration with everyone in the room. He is
concerned that we tend to focus on the delays and the inefficiencies that take us
away from the big picture of the focus on research. See the slide presentation
for more information on the overview of the Ottawa Hospital Research Ethics
Board and the process they follow.

      Click here to download Ray Saginur’s PowerPoint presentation (47 KB)

6. A New Paradigm For Drug Development In Canada

   6.1.     Speaker: Robert Peterson (Therapeutic Products Directorate, Health
          Canada)

        Dr. Peterson mentioned that global pharmaceutical R & D expenditures
are rising with the biggest limitation being funding. In Canada, Dr. Peterson
wants to create incentives fro drug development when the marketplace does not
and insists that we have to rethink the drug approval process. His concerns lie in
safety studies and their expectations and firmly believe in the reporting of
adverse events that occur. He mentions that clinical trials are typically powered
to assess efficacy, not safety and lists safety as a relative term. In his view, we
must increase the focus on safety in the post-approval phase.

        Many of the issues are associated with large numbers of drugs entering
trials, but small numbers finishing the trials due to failure along the way. In
order to reduce the number of failures and therefore costs, we have to focus on
the phase that we can influence the most.

       There must be greater public involvement. We must recognize some
element of cost containment, have better early access for promising therapies,
and better data in actual drug usage. We need to challenge the existing rules.
See slide presentation for more details.

      Click here to download Robert Peterson’s PowerPoint presentation (764 KB)

7. Improving Governance And Contracting Procedures For Clinical
   Research

   7.1.     Speaker: Rob Hanlon (OHRI)




                                                                                  32
       The OHRI has about 1100 research staff and about $18 million in external
research funding. This has increased about 25% over the last four years. The
OHRI has over 1000 active clinical research projects ongoing. They have
enhanced their staff with a full time lawyer and additional staff to support the
REB. They face many challenges such as cash flow, confidentiality, governing
laws, insurance, health care restructuring, space constraints and changes, and
MD and staff morale. See slide presentation for additional details.

      Click here to download Robert Hanlon’s PowerPoint presentation (1.2 MB)

   7.2.   Speaker: Nestor Nituch (Bristol-Meyers Squibb)

       If Mr. Nituch could key in on two areas they would be realistic
expectations and recruitment. About 33% of studies do not recruit a single
patient. He sees difficulties with site performance. He equates them with
mutual funds, as it is difficult to see performance. Ethics is another concern.
There is a need for efficient ethics and consent processes. Lastly, he addressed
the issues with US based pharmaceutical companies, as they don’t understand
our medical system.

8. Panel Discussion: How Can Regional Hospitals Collaborate?

   8.1.   Chair: Ron Worton (OHRI)

         Dr. Worton posed the question: “Is clinical research regional collaboration
feasible and desirable?” Other questions he asked are: how can we better
collaborate, with industry and with government; he asked the panellists to think
about some of the elements of a regionalization and to comment on cooperative
research planning such as co-ordinated staff recruitment strategies and fostering
trials in children; and about health services research.

   8.2.   Speaker: David Moher (CHEO)

       Dr. Moher stated that hospitals do indeed work together and gave two
examples where this is the case. He wanted to expand our working relationships
into a much broader regional community, larger than Ottawa-Carleton. He wants
Ottawa to be a hotbed for clinical research, just like Montreal is. In a bold
statement, he mentioned that we must “check our egos at the door” and work
together to develop better recruitment networks. He felt that there is a
reluctance to share data, as well there is a tremendous human resource that we
need to share. Dr Moher feels that by coming together, it will facilitate clinical
research, not impede it. He dreams of having a community research centre in
two or three years time.




                                                                                  33
   8.3.      Speaker: Larry Chambers (EBRI -- Elisabeth Bruyére Research
          Institute)

    Dr. Chambers reported that the challenge of the EBRI is to conduct clinical
research on continuing care, that is, health care outside acute care facilities.
EBRI is a virtual centre across the community conducting research in long-term
care, complex continuing care, palliative care and primary health care. The EBRI
was established in 2000 and now has 18 scientists and over 50 support staff.
Over $5 million in external grants were received for the 2005-2006 fiscal year. .
The Institute presently supports a number of groups of independent
investigators who are overseeing research programs including: End of Life Care
for seniors (CIHR New Emerging Team), Canadian Driving Research Initiative for
Vehicular Safety in the Elderly (CanDRIVE, CIHR New Emerging Team),
Technology Assisted Friendly Environment for the Third Age (TAFETA),
Community Hypertension Awareness Program (CHAP), Aging and Movement, and
inter-disciplinary nursing, pharmacy and family medicine primary care through
the C.T. Lamont Research Centre.

Dr. Chambers advocated for research infrastructure support for continuing care
organizations. For example, there are 600 long-term homes on Ontario with
75,000 residents and 100,000 staff. The new Long Term Care Home Act it should
include a provision for the Ministry of Health and Long-term Care to fund
education and research in these organizations in collaboration with universities.
Ottawa must provide an array of opportunities for investigators to be nurtured
through collaboration across health care sectors

   8.4.     Speaker: Brian Malcolmson (Monfort)

       Monfort is a full teaching hospital with an academic mission. In the fall of
2003, they put in a research committee and have looked at about 30 research
projects so far. They do not have a research institute. About 20% of the 30
projects are clinical trials, which is not a lot. The interest lies in the culture and
population of communities in the area with primary and secondary care of the
population categorized as important. They have three research projects starting,
including a study on obesity. They have partnerships, one of which is from the
University’s Faculty of Sciences. The Institute of Research Elizabeth Bruyère has
a project on site at Monfort.

         Monfort is junior at research and are seeking our opportunities for a pair-
up with expertise. They currently have trials in the area of cardiology, internal
medicine, and pharmacy and will pair up with the Canadian Forces in the near
future. The hospital looks forward to doubling their patient capacity by 2007 and
is looking at career paths that involve research for their health professionals.




                                                                                   34
“We are open for business, but are not an institute yet”. Monfort is looking to
build a team and to build partnerships.

   8.5.   Speaker: David Crowe (Queensway-Carleton Hospital)

        Queenway Carleton is not a research or teaching hospital. Dr .Crowe
admits that he does not have a lot of experience-based comment on how to
make this all happen. His main interest of being here is the possibility of
establishing a central ethics board. He participates in four or five pharmaceutical
trials a year.

   8.6.   Speaker: Zul Merali (Royal Ottawa Hospital)

        Dr. Merali oversees all research that takes place at the Royal Ottawa
Hospital. He says that the Romanow Report and the Kirby Commission mentions
that mental illnesses are apriority, yet research does not reflect this. Dr. Merali
informs the group that the Royal Ottawa Hospital is the third largest mental
health institute in the country yet feels that not enough is being done in this
field. Also, there are several opportunities that are presenting themselves and
coming together as a region that provides us with access to populations in order
to access these opportunities. Dr. Merali sees opportunity to do post-marketing
surveillance, but is curious on how to get into communities to build relationships.
Unique opportunities come from diverse populations, which there are in the
region. He suggests that a mobile clinic might be effective in areas where there
is not an in-house capacity.

   8.7.   Speaker: Rob Roberts (University of Ottawa Heart Institute)

       Dr. Roberts is not too familiar with Canadian climate with trials as he has
been here only 9 months. He definitely has an interest in trials and feels that we
have a large enough population that would give a good opportunity to study
cardiovascular genetics. His viewpoint is that we cannot “leave our egos at the
door” because clinical trials start with an academic endeavour. It is the ambition
and the drive that these people have that allow an organization to succeed. We
cannot destroy that. If you do, you will have an excellent organization that
yields no results.

       Dr. Roberts wondered if trials could be disease based. Only in certain
diseases can the study be designed the same, such as obesity and diabetes, but
others will have to be specialty designed, such as cancer. His own interests are
in coronary disease.

   8.8.   Questions and Comments:




                                                                                  35
   Q. How do we involve the community hospitals and outreach?
   A. (Rob Roberts) – have 34 hospitals and daily conferences, common
      newsletter and push forward with recruitment
      Ron Worton – we have an easier job integrating because we have one
      academic centre – teaching hospital/medical school
      David Moher – education – go to the hospitals and get involved

      Comments:

          -   Rob Roberts, you are correct regarding collaboration and egos,
              they are a source of energy and power, but also can be a
              hindrance. You need to collaborate in order to get to study the
              patients and you need to work together. So, “tone down a bit your
              frank comment”. Is the panel willing to meet again in the next
              month? In other words, to “get our act together”?
          -   (Brian Malcolmson) – Monfort is presently participating in a
              Francophone grouping for reasons of clinical services and academic
              mandate. We are ready to move in those areas and are ready to
              participate in a bigger way.
          -   (Larry Chambers) – organizations we set up for research have to be
              sure everyone works in a collaborative environment in an
              environment they can excel. I agree with Rob Roberts.
          -   (Monique Bégin) – you mention that Queensway-Carleton is not a
              teaching hospital. I hope that categorizing is not there when we
              collaborate. Patients are in every hospital, teaching or not
              teaching. Be aware of the dangerous division. Everyone is at the
              table even though they are or are not teaching!!
          -   (David Crowe) – I have a hospital full of professionals who are busy
              but the non-teaching hospitals do not have the resources to think
              about research. I am concerned what is expected from a
              community hospital in a collaboration.

9. Centre for Applied Health Research:

   Speaker: Ron Worton

    Dr. Worton presented a geographical and architectural overview of the Centre
for Applied Health Research. It would be housed at the Smyth Road Health
Sciences Campus. It would be a three story building with the lower floor being a
clinical epidemiology research centre, the middle floor being the clinical trials
research facility, and the third floor housing the population health research
group.




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   10.   Breakout Groups:




Group 1: “Relations Between the Sites and the Sponsors”

Comments:
- Seemed to be a duplication of resources and who they needed to speak to
- Better definition of scope needed
- More streamlined approaches to site start up
- Recognition of start-up
- Training – additional training given by the sponsor

Questions:
Q. Do you feel this is a useful formula that can continue in a regional perspective?
A. Periodic
A. Coordinators hate to be left out of the discussions




Group 2: “Regional Ethics Board and Facilitating Contracts”

Comments:
- Lots of examples and experiences
- General support for regional ethics board
- Concerns: funding, part-time or full time or volunteer members of regional ethics
   board, continuous functions?
- Respecting the different populations (minority for example)
- Sense of fairness for small institutions – for example community hospitals
- Consent forms, who would do it? Would industry come together and agree on
   templates?
- Best practice from other locations. Alberta – provincial REB
- Structure of the regional REB and how it would function with governance

Questions:
- none




                                                                                  37
Group 3: “Issues of Training”

Comments:
- None of the group had formulize training: trial by fire
- Must be a better way
- Training is very important
- It is many a time the last thing that gets dealt with
- Institutions responsibility
- Educating the public on what is research
- Educating the public on good clinical practice
- Standardized training for investigators
- Research coordinators – ensuring we have standardized training and ongoing
   training. It is a lifelong process. Protocol is complex.
- Standardized program within the research facility.
- Variety of ways of learning: mentoring, workshops, pair-up of less experienced
   with more experienced.
- Various qualifications that we have as research coordinators and have the
   necessary qualifications.

Questions:
Q. Institutions responsibility? Financial or competence?
A. Financial and time

Comment:
- Important to have centralized training

Comment:
- Industry should be part of training and education

Comment:
- There must be some resources for training.

Comment:
- I think it could be a benefit to the Ottawa region if we train our staff throughout
  the region.




                                                                                   38
Group 4: “New Paradigm”

Comments:
- Mounting pressure to revisit the drug discovery model that has been in place for
   decades
- Trying to come up with a more productive paradigm
- Address the high failure rates
- Reduce the need for mega clinical trials
- Felt the new paradigm should keep in mind the international efforts
- Should be a cooperative approach –academia, industry
- In conjunction with the new approach to drug discovery and development,
   consideration for return of investment.
- Need to look at how the meds would be paid for by various systems
- In terms of the science itself – the impact of pharmaceutical genetics
- Smaller trials
- Issues of ethics related to that
- Use of diagnostic tests to segment
- Question whether Canada should be a leader or a follower – some potential with
   current tissue banks and links to data bases at the provincial level
- In the shorter term, the number of phase 3 studies would see a genetic
   component piggybacked onto that, but there are ethical issues
- How the gene relates to the disease
- Broader request made that the material can be used for any research because
   technology may evolve in that time. The amount of knowledge to be gained with
   the new tech
- Intellectual property protection
- Hurdles to overcome regarding intellectual property agreements
- Technology to improve markers
- International jurisdictional issues
- Smaller clinical trials in the development phase
- Where should the risk balance be, from whose prospective, the patient

Questions:
- None

Comment:
- Information is king. We are home of the regulators in Ottawa. We have a
   unique setting to put together a regulatory chair. Linkage back to the health
   care system is important.

Comment:
- University of Arizona and the FDA. Maybe we can set up our own global institute



                                                                                   39
Group 5: “Leadership, Funding, and Governance Structure”

Comments:
- Goal: we are all in it to improve patient care
- Why in Ottawa? We need to look at how we achieve a clinical advantage in
   Ottawa. We need to identify gaps, such as training. We need to outreach.
- In the end it is about the leadership and the funding being brought to the table
- We have to put a plan together
- Put stakeholders, key leaders together
- Need commitment from all of us
- Bring a strong man to the table at some time
- Must bring our resources together
- Need involvement and alignment
- Need to build a broader network of stakeholders
- Also have to connect and validate with industry
- It is all about communication, communication, communication
- Have to think global and act global
- There is money to support some of these things, but you have to demonstrate
   your impact to the health care system
- Cost is the driver

Questions:
- None




   11.    Conclusion and Wrap-Up:

      11.1. Speaker: Paul Hébert

            Dr. Hébert felt that this conference has been productive. He believes that
   research activities saves lives and improves lives of the individuals served. To
   attain these goals, he believes that clinical research has to be part of the
   paradigm. In order to do this, Dr. Hébert mentions that we have to think of
   innovation and think of the mechanisms of disease and bring that to the bedside.
   It is critical to develop leadership, mentorship, support and training to all health
   care professionals. There are some barriers, Dr. Hébert admits, but concludes
   that we need to work together to get it done.




                                                                                    40
   11.2. Speaker: Judy Erola

        Ms. Erola wants the Ottawa health centre to be bold, new and daring.
She believes that our strengths are genetic researchers. She wants us to have
an international chair in regulation. She believes that the will is here and the
talent is here and concludes that if we don’t move quickly, we will lose the
momentum.

   11.3. Speaker: Ron Worton

         Dr. Worton admits that in the last hour, the conference had evolved a
little differently. He wants a champion that will move this forward that will
communicate to all the hospitals in the region. This champion will be also
involved with the university. A standing committee will need to be formed that
should include a spectrum of ten or so people. A research coordinator will also
be required. Dr. Worton questioned whether or not there should be a press
release of the conference.

   11.4. Chair: Monique Bégin

      Mme Bégin concluded the conference, and offered that this calls for
developing public support because “if there is no demand, nothing gets
approved”!




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12.   List of Speakers:

The Hon. Judy Erola PC (University of Ottawa)
The Hon. Monique Bégin (University of Ottawa)
Dr. Peter Walker (Dean, Faculty of Medicine, University of Ottawa)
Dr. André Potworowski (Centre for Research in Biopharmaceuticals &
Biotechnology, University of Ottawa)
Dr. George Wells (Chair & Professor, Faculty of Medicine, University of Ottawa)
Dr. Paul Hébert (Professor of Medicine, University of Ottawa)
Mr. Ken Lawless (President & CEO, OLSC)
Ms. Donna Marcelissen (Patient)
Ms. Deanna Silverman (Patient)
Ms. Pat Froio (Canadian Cancer Society)
Mr. Pierre Gervais (President, Q&T Research Inc., Sherbrooke, QC)
Dr. Ron Worton (CEO & Scientific Director, Ottawa Health Research Institute)
Dr. François Bertrand (Senior Director, Clinical Research, Merck Frosst)
Dr. Pierre Meulien (CEO, The Dublin Molecular Medicine Centre, Ireland)
Mr. Nestor Nituch (Unit Director of Regional Clinical Operations, Bristol-Myers
Squibb Canada)
Mr. François Le Barbenchon (Client Relations Director & Administrative Head,
Covance Canada Inc.)
Mr. Ken Newport (Senior Vice President, Business Dev., PRA International)
Mr. Sven Blumenstiel (Associate Partner, Global Pharmaceutical Practice, IBM)
Dr. John Cairns (Project Director, Canadian Institute of Health Research)
Dr. Robert Phillips (President & CEO, Ontario Cancer Research Network)
Dr. Ray Saginur (Chair, Ottawa Hospital Research Ethics Board)
Dr. Robert Peterson (DG, Therapeutic Products Directorate, Health Canada)
Mr. Rob Hanlon (COO, Ottawa Health Research Institute)
Dr. David Moher (Program Director, Clinical Research, CHEO)
Dr. Larry Chambers (President, Elisabeth Bruyère Research Institute)
Dr. Brian Malcolmson (Director of Academic Affairs, Monfort Hospital)
Dr. David Crowe (Chair, Department of Psychiatry, Queensway-Carleton Hospital)
Dr. Zul Merali (President/CEO and Scientific Director, Institute of Mental Health
Research at UofO, Royal Ottawa Hospital)
Dr. Rob Roberts (CEO, University of Ottawa Heart Institute)




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