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					                                   Submission
                                      to the
                          Clinical Trials Action Group
                               12 February 2010

                           Roche Products Pty Limited




Roche Products Pty Limited
Corporate Affairs: +61-2-9454 9969; email australia.corporateaffairs@roche.com   1/11
Submission to the Clinical Trials Action Group




Background

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with
combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech
company with truly differentiated medicines in oncology, virology, inflammation, metabolism and
CNS.

Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer
in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and
diagnostic tools that enable tangible improvements in the health, quality of life and survival of
patients.

In 2009, Roche had over 80’000 employees worldwide and invested almost 10 billion Swiss francs in
R&D. In Australia, Roche has invested heavily in local research (approximately $36 million in
pharmaceuticals alone in Australia in 2008).

Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority
stake in Chugai Pharmaceutical, Japan.

For more information: www.roche.com


For any further information in relation to this submission please contact:

Corporate Affairs
Roche Products Pty Limited
4-10 Inman Road, Dee Why, NSW, 2099, Australia

Telephone:               +61-2-9454 9969
Facsimile:               +61-2-9982 5269
Email:                   australia.corporateaffairs@roche.com




Roche Products Pty Limited
Corporate Affairs                                                                                  2/11
Executive Summary

Roche Products Pty Limited commends the government for addressing the needs of clinical trials in
Australia and inviting submissions from stakeholders.

Roche has one of the largest clinical trial departments in the Australian pharmaceutical industry.
This has provided access to innovative therapies for physicians and patients as well as a providing a
substantial multi-million dollar injection of funding into the Australian health care sector for more
than 20 years. In addition to this, the need for high quality research has provided an opportunity
for training, development and employment of health care professionals both at clinical trial sites and
of professionals at sponsor companies. Australia has been at the forefront in clinical trials in the
region and our health professionals have been accorded global and regional respect as part of this.

Clinical trials are at a cross-roads in Australia. Whereas our clinical trial activities and number of
studies have increased for many years, competition from other countries and regions has seen this
activity start to plateau. We note that other Australian sponsors have already reached a peak in their
clinical trial activity and their departments and activities are now in decline, their activities having
been taken over by other countries. Australian investigators are no longer seen as vital to include in
any global study of innovative therapies.

What is needed is government action to address this reduction in activity and to create a positive
environment to ensure sustainability and resumption of growth for this value-adding, patient-
focussed clinical trial industry.

Roche recommends a number of key actions which are summarised as:

Government funding and incentives to:
-   Increase the proportion of patients and centres in clinical trials.
-   Reduce barriers to the prompt start-up of studies.
-   Introduction of transparent metrics to identify and encourage high performing sites.
-   Reduce barriers to recruitment, including encouraging cross-physician and cross-institution
    referrals, which would include coalescing physicians within therapeutic areas in each major
    city, as well as transparent information for patients to identify trial sites.
-   Measures to encourage adoption by the states and institutions of the current harmonisation
    measures (HoMER) with rights to institutional refusal of a HoMER decision limited to certain
    allowable matters.
-   An increase in professional and soft-skill training and career structures for study coordinators
    who work at institutions.
-   Financially reward and publically acknowledge secondary and tertiary referral institutional
    participation and performance in clinical trials.




Roche Products Pty Limited
Corporate Affairs: +61-2-9454 9969; email australia.corporateaffairs@roche.com                       3/11
Submission to the Clinical Trials Action Group




1.     Response to Developing a Clinical Trials Roadmap – Discussion Paper One

Key success factors are essential to the measurement of the improvements in clinical trial
performance for institutions, sponsors and government. Ideally these should be accessible to these
groups, to allow identification of best performance, initiatives and best practice that could be
adopted by all.

Currently, we only have a finite picture of our own performance in institutions where Roche has
already undertaken clinical trial activities. This lack of knowledge over the whole of the clinical trial
sector impedes confidence in identifying and utilising new and additional sites and in ensuring
effective risk management. Measures to be shared could include:

Recruitment Performance
•   Total recruitment by institution, stratified by year, therapeutic area and study phase
•   Institutional average actual patients/site/month vs planned institutional rate
•   Proportion of patients in a clinical trial vs. standard of care treatment in an institution
    stratified by therapeutic area
•   Sponsors may voluntarily self-report to NHMRC on the proportion of studies that were able to
    be undertaken in Australia compared to the APA region by phase and therapeutic area, which
    would identify negative trends
•   Time taken from final protocol to first patient recruited by institution

Resourcing Requirements/ Institutional Efficiency
•   Benchmarking of man hours required in (pre-initiation) start-up, man hours per patient
    recruited, man hours for study closedown
•   Average time from submission to Ethics and Governance approval by institution published by
    quarter
•   Average time from Ethics and Governance approval to first patient recruited by institution
    published by quarter

Australian Trial Activity and Employment Opportunities in the Sector
•   Number of studies notified to the TGA (CTNs) by quarter, and number of sites per study
    stratified by drug development phase and state
•   Total FTEs employed in Australian institutions for conducting development studies
•   Total FTEs involved in clinical research employed in Pharma and CROs

Investigator/ Institution Trial Information and Quality
•    Number of protocol violations, measured by average violations per patient by therapeutic area
•    Training Programmes in place for research teams at an institution
•    Proportion of clinical research revenue retained within research funds for use by the research
     team
•    Average treatment cost for standard of care (for comparison)
•    Phases of research currently conducted at an institution
•    Therapeutic areas where clinical research is being conducted




Roche Products Pty Limited
Corporate Affairs                                                                                     4/11
Submission to the Clinical Trials Action Group




•      Number of scientific papers in peer reviewed journals where an institutional PI is a lead or
       named author
•      Number of audits and audit findings per year

Commercial Attractiveness of the Australian Environment
•  Proportion of new medical entities/indications submissions to TGA that are approved and PBS
   reimbursed in Australia

Careful consideration would need to be given to how this measurement information would be
collected and any additional administrative burden this might create. The list of measures provided
however give an outline of the type of information it would be useful to have accessible to all.


Existing Initiatives>Regulatory>Ethical and Scientific Review

HoMER is a valuable initiative, yet there is no significant institutional incentive for individual
institutions to adopt the centralised ethical decision.

Accreditation of an Ethics Committee and an Institution for Clinical Research should be contingent
upon adopting a HoMER decision for local usage unless there are “allowable” matters that require
further consideration, these may be upon treating a subpopulation that have additional health
concerns (e.g. aborigines) and/or a non-English speaking Ethnic group who require translations on
consents etc, but rejection of a central HoMER decision may not be allowed on religious or other
non-Medical grounds.

Roche would recommend that sponsors could appeal, and potentially accreditation for an Ethics
Committee be withdrawn, if there are extraneous concerns impeding the consideration, trial
approval and start-up at a particular institution.




Roche Products Pty Limited
Corporate Affairs                                                                                     5/11
Submission to the Clinical Trials Action Group




2.     Response to Developing Key Performance Measures for Clinical Trials –
       Discussion Paper Two

Roche as a sponsor who has run more than 100 studies in Australia in recent years, has anecdotal
evidence that approval and start-up timelines are lengthening.

Whereas over a two year period from 2007 to 2009 timelines from submission of a clinical trial
package to approval by an Ethics Committee was on average 2-3 months, it was evident that the
subsequent time to initiation was several months later again, mainly due to governance issues at
sites.

It is clear that governance is being considered after ethical approval rather than in parallel as
envisaged. However, having stated that the average ethics approval times are 2-3 months, it is noted
that there are significant outliers where individual institutions take a decidedly different view from
the majority and Ethics approvals may be delayed as well. Whereas this is not unforeseen, where
HoMER is not in place we would still contend that if we have a number of Ethics approvals in
Australia, then other Ethics Committees should recognise that there is a degree of comfort in the
decision and that later ethics approvals should be streamlined.

Clinical Trial Performance Indicators

In terms of what indicators should be put in place, and by whom, it is recommended that
consideration be given to institutions self-report to the NHMRC (unless otherwise specified below),
who would publish the data on a Commonwealth Government website. Please find attached the
listing of success factors also presented in response to Paper One. We acknowledge that this might
create additional administrative burden and further consultation with investigators and clinical trial
centres would be required.

Good institutional performance data could then be used by sponsors such as Roche, to assert to our
global teams that Australia deserves more sites and patients that could contribute to the global total.

Recruitment Performance
•   Total recruitment by institution, stratified by year, therapeutic area and study phase
•   Institutional average actual patients/site/month vs. planned institutional rate
•   Proportion of patients in a clinical trial vs. standard of care treatment in an institution
    stratified by therapeutic area
•   Sponsors may voluntarily self-report to NHMRC on the proportion of studies that were able to
    be undertaken in Australia compared to the APA region by phase and therapeutic area, which
    would identify negative trends
•   Time taken from final protocol to first patient recruited by institution


Resourcing Requirements/ Institutional Efficiency
•   Benchmarking of man hours required in (pre-initiation) start-up, man hours per patient
    recruited, man hours for study closedown
•   Average time from submission to Ethics and Governance approval by institution published by
    quarter


Roche Products Pty Limited
Corporate Affairs                                                                                   6/11
Submission to the Clinical Trials Action Group




•      Average time from Ethics and Governance approval to first patient recruited by institution
       published by quarter

Australian Trial Activity and Employment Opportunities in the Sector
•   Number of studies notified to the TGA (CTNs) by quarter, and number of sites per study
    stratified by drug development phase and state
•   Total FTEs employed in Australian institutions for conducting development studies
•   Total FTEs involved in clinical research employed in Pharma and CROs

Investigator/ Institution Trial Information and Quality
•    Number of protocol violations, measured by average violations per patient by therapeutic area
•    Training Programmes in place for research teams at an institution
•    A listing of investigators who have ongoing institutional support to be considered Principal
     Investigators, to be reviewed at regular intervals
•    Proportion of clinical research revenue retained within research funds for use by the research
     team
•    Average treatment cost for standard of care (for comparison)
•    Phases of research currently conducted at an institution
•    Therapeutic areas where clinical research is being conducted
•    Number of scientific papers in peer reviewed journals where an institutional PI is a lead or
     named author
•    Number of audits and audit findings per year

Commercial Attractiveness of the Australian Environment
•  Proportion of new medical entities/indications submissions to TGA that are approved and PBS
   reimbursed in Australia


The National Healthcare Agreement (NHA) Reporting Structure

In the interests of transparency and continuous improvement, the above measures could be put in
place for all institutions (and TGA and sponsors where appropriate) conducting sponsor-driven
Phase I-IV clinical research studies. We would recommend that consideration be given to self-
reporting to the NHMRC and the posting of information on a centralised website.




Roche Products Pty Limited
Corporate Affairs                                                                                   7/11
Submission to the Clinical Trials Action Group




3.     Response to Ensuring the Rapid Uptake of Streamlined Ethics, Scientific and
       Governance Review Process – Discussion Paper Three

Ethics and Scientific Review

We wish to support the rapid adoption of HoMER to minimise the undue workload and individual
institutional barriers that are impeding clinical research in Australia. Sponsors should have the
opportunity to go to an accredited Ethics Committee of their choice so as to ensure that there is
efficiency and timeliness for start-up.

The following are additional measures that we would recommend:

•      Ethics accreditation being dependent on adoption of HoMER processes 1
•      Funding for institutional research staff from State and Federal governments is contingent
       upon adoption of HoMER processes
•      As previously stated, the NHMRC should publish average Ethics approval metrics
•      Ethics fees being contingent upon meeting a timeframe for an Ethics decision after a
       submission
•      Institution should also be accredited for Clinical Research based on resources, and appropriate
       processes
•      We would also request a recommended cap on fees for institutional preparation and
       consideration of ethics submissions, which have grown at a great rate in recent years. These
       submission fees being in the order of:
       o not more than $2500 if the site does not use the HoMER decision and/or standard
             contract agreements and/or is recognizing a HoMER decision from another committee
       o not more than $4000 for a committee that makes a HoMER decision.


Research Governance Review

We have identified that as a sponsor, governance has slowed study start-up significantly in recent
years. Despite government plans, institutions are undertaking governance issues subsequently to the
Ethics submission being approved rather than in parallel. We would request a time clock on
governance considerations of a maximum of 30 days post Ethics decision, otherwise submission fees
are reduced by 50%. This would provide institutions an incentive to ensure rapid start-up.




1
  Accreditation being contingent upon adopting a HoMER decision for local usage unless there are “allowable” matters
that require further consideration, these may be upon treating a subpopulation that have additional health concerns (e.g.
aborigines) and/or a non-English speaking Ethnic group who require translations on consents etc, but rejection of a
central HoMER decision may not be allowed on religious or other non-Medical grounds. We would recommend that
sponsors could appeal and potentially accreditation for an Ethics Committee be withdrawn, if there are extraneous
concerns impeding the consideration, trial approval and start-up at a particular institution.



Roche Products Pty Limited
Corporate Affairs                                                                                                     8/11
Submission to the Clinical Trials Action Group




4.     Response to Strategies to Improve Patient Recruitment – Discussion Paper 4

Background

Roche notes that some of our best recruiting sites have the following characteristics:
•   a good surgeon/physician referral network within the institution or city;
•   a group of co-located investigators who have sub-specialties within the institution, which
    allows all suitable patients to be referred to a few specialists only;
•   a group of like-minded investigators who deal with patients with the same disease within the
    capital city, understand that sponsors only have a limited number of study sites that can be
    placed in Australia and who will willingly cross-refer to each other;
•   specialists who have a close relationship to many referring GPs and/or who will make media
    appearances to interest the general public; and
•   a dedicated research team of coordinators who support the management of the study, are
    experienced and have rapport with that patient group and who help identify many appropriate
    patients from clinics.

We would encourage any government measures which can expand this coverage to other cities
and/or therapeutic areas.

Unfortunately we have noted that for certain groups cross-referrals within the institution or
between institutions is less common.

Potentially recruitment may be improved through increasing rewards and recognition for successful
referrals and providing visiting rights to institutions for physicians who are motivated to do clinical
research and bring potential trial patients to the institution.

As studies become more complex, particularly in oncology, it has become increasingly hard for
physicians and/or patients to identify trial options on current clinical trial websites. Investigators
are reporting that the current websites are too difficult for them to use, let alone their patients.
Therefore an effort should be made to make the clinical trials websites more easy to find and
navigate. If this is improved then the subsequent step of patients registering their interest in clinical
trials may be improved.

GPs are often not sufficiently informed regarding studies or are too busy for referrals. Referral
and/or finders incentives, upon successfully meeting inclusion/exclusion criteria could be become
standardized practice in Australia. This may be facilitated by an add-on to patient mgt/prescribing
software, facilitating a pop-up for a possible patient in certain post codes. Engagement would then
be enhanced via sponsors and/or providing template letters to be sent to the GP on patients
progress, at regular intervals.

Way forward

In addition to the above, coordinated patient referral networks are to be encouraged. Currently
relying on letters being sent to other doctors by investigators only meets with limited success,
additional mechanisms of allowing patients to identify other referral options for themselves should
be encouraged.



Roche Products Pty Limited
Corporate Affairs                                                                                     9/11
Submission to the Clinical Trials Action Group




5.     Response to Developing an Information and Communications Technology (ICT)
       Strategic Plan for Clinical Trials – Discussion Paper Five

Background

Potential scope for e-health in Clinical Trials

Roche as a sponsor involved with many institutions throughout the world, we foresee the benefits of
e-health. However, technical impediments have been common, so whereas we encourage this, it
should not be to the detriment of the initiatives in the other discussion papers presented.

a) Trial feasibility and patient recruitment
   We would recommend for this initiative to be very helpful to us, E-Health records would need
   to be queried down to an Area Health Service region, so a sponsor knows where the patient pool
   is, not just that it is generally available in Australia.

b) Remote monitoring of clinical trials
   We would commend that access to clinical trial records remotely is supported, however a single
   interface type for hospitals must be part of this solution, as a sponsor cannot put in place the
   infrastructure to access multiple systems that various institutions may put in place.

c) Trial approval
   Any CTN handling improvements will assist, however this application should more importantly,
   also track the governance process, which as previously stated should be run in parallel but does
   not. The governance issue is the greatest need and improvement that could be made to start-up
   timelines. However, an overall tracking system may facilitate identification of other
   impediments to rapid start-up that could be addressed.

d) Management of Clinical Trials
   A central record of essential documents, such as Investigator CVs, Ethics meeting dates and
   ethics membership, laboratory accreditation and normal ranges etc., would be beneficial for
   institutions and sponsors alike. This central repository could be populated by either the sponsor
   or the institution or trial site. This will aid reduce time-consuming and resource intensive
   searching for start-up documents.

e) Longer Term Monitoring of patients
   We note with caution the utilisation of additional patient data to aid PBAC decision making.
   We wish to point out that Australia is currently only contributing approximately 3% of the
   global development programme patients. As such extreme caution is warranted as the
   Australian patients reported upon would only be a subset of the overall study data.
   Furthermore, data would be confounded as individuals receive other treatments. Whereas
   sponsors may use this information for tracking, the data would be amalgamated with the global
   pool prior to any analysis.


Development of a Clinical Trials ICT Plan

Whereas we agree with the formulation of an ICT plan and the major points in this Discussion


Roche Products Pty Limited
Corporate Affairs                                                                               10/11
Submission to the Clinical Trials Action Group




Paper we would request that the following areas of detail are carefully considered as part of this plan:

•        specific and continuing clinical trial need for the collection of data up until consent is
         withdrawn (if this occurs), needs to be taken into account
•        data needs to be in a common viewable format to facilitate remote monitoring
•        data systems needs to comply with EU Directives and FDA 22CFR11 requirements
•        independent and private clinical trial centres should have access to the same technology free of
         charge to facilitate e-health for clinical trials
•        privacy legislation may need to be amended to allow patient e-health data to be viewable for
         trials or audits


HoMER background - Overview

We fully support the implementation of HoMER as a means to drive efficiency in clinical trial start-
up. Some measures to encourage adoption of HoMER decisions (as previously stated) may be:

     •     Ethics accreditation being dependent on adoption of HoMER processes 2
     •     Funding for institutional research staff from State and Federal governments is contingent
           upon adoption of HoMER processes
     •     Institutions should also be accredited for Clinical Research based on resources, and
           appropriate processes


e-Health Case Studies – Australian and International

Whereas we encourage e-Health initiatives, we wish to make the observation that most of these case
studies have only a perceived future benefit, the only hard metric being a faster closedown time for
one example. Any e-health initiative needs to come with metrics around tracking increased data
quality and reduced sponsor and institution resource utilisation, in order to measure and
demonstrate the benefits.




2
  Accreditation being contingent upon adopting a HoMER decision for local usage unless there are “allowable” matters
that require further consideration, these may be upon treating a subpopulation that have additional health concerns (e.g.
aborigines) and/or a non-English speaking Ethnic group who require translations on consents etc, but rejection of a
central HoMER decision may not be allowed on religious or other non-Medical grounds. We would recommend that
sponsors could appeal and potentially accreditation for an Ethics Committee be withdrawn, if there are extraneous
concerns impeding the consideration, trial approval and start-up at a particular institution.



Roche Products Pty Limited
Corporate Affairs                                                                                                    11/11

				
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