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  Issue 11                                                                                     Winter 2009


             ‘  Welcome to the UKCRC Winter
                2009 Update.

The UKCRC continues to contribute to improving
the environment for clinical research in the UK
and this edition of the Update highlights some
                                                     activities. An article in this issue of the Update
                                                     introduces the final report, which is a valuable
                                                     information resource that can be put to use by
                                                     organisations as they take their own patient and
                                                     public involvement activities forward.

recent developments.                                 I am also pleased to announce that Sarah
                                                     Qureshi, the new UKCRC Partnership Manager, is
Effective communication about the improvements       now in post. Sarah’s arrival makes the transition
that have already been made to the environment       of the UKCRC to a Partner-led model both
for clinical research is crucial. A new guide for    tangible and complete.
researchers, developed by the UKCRC Partners
and other stakeholders, has been published and       The article on the next page describes how lead
describes the transformation of the regulatory       Partners will be taking forward UKCRC work
and governance environment. This guide not only
outlines what has changed but also how it all
is intended to fit together and will, I hope, be a
                                                     during 2010 and I’m sure there will be further  ‘
                                                     fruitful and exciting opportunities for us all to
                                                     work together to strengthen the future of clinical
valuable tool to researchers.                        research in the UK.
                                                     The UKCRC’s New Partner-Led Model
Another recently completed project has been an       Professor Dame Sally Davies
assessment of lessons learned from the process of    Chair, UKCRC
developing UKCRC patient and public involvement

In this issue:
      Progress with the UKCRC Partner-led
2     Model                                                    3    Regulatory and Governance Guide

      Model Agreements for Collaborative                            Patient and Public Involvement -
3     Commercial Research                                      4    Lessons Learned
Introducing the UKCRC Partnership Manager

                                      My name is Sarah Qureshi and I am very pleased to have been
                                      recently appointed as the UKCRC Partnership Manager. Research
                                 has always been at the heart of my career path. For the past six years I
                                 have led on the Royal College of Obstetricians and Gynaecologists work
                                 in regulation. Other aspects of my knowledge and expertise have been
                                 developed through working for the Human Fertilisation and Embryology
                                 Authority, the Health Protection Agency, the pharmaceutical industry and
                                 also through completing a postgraduate management degree.

 Since I joined in mid-November, I have been made to feel very welcome at Park Crescent and I am very
 excited to be part of the evolution of the UKCRC. I hope you will join me in helping to take our work
 forward and making the new Partner-led model into a great success.

 I am fortunate that the transition has included a handover period, which has permitted relevant
 knowledge of the outgoing staff team to be passed on. I look forward to meeting many of the Partners
 over the coming months but please do not hesitate to make contact if there are particular issues you
 wish to draw to my attention.

 Sarah Qureshi (sarah.qureshi@ukcrc.org)

Further Progress with the UKCRC’s New Partner-Led Model
The transition to a Partner-led       ► The Experimental Medicine           biotechnology and medical
model of activity has driven a          Funders Group, convened by          technology industries and the
number of changes in the way            the Medical Research Council        role these industries might
that the UKCRC operates. At the         (MRC), will continue its joint      play in enhancing the clinical
UKCRC Board meeting in November         work to promote and coordinate      research environment in the UK
2009 the remaining mechanisms           activity in experimental
for delivery were agreed, with          medicine research within the     ► INVOLVE is the UKCRC’s lead
lead Partners identified and,           UK                                 Partner for patient and public
where appropriate, supporting                                              involvement and will continue
collaborative groups. All groups      ► A UKCRC Regulatory and             to support specific UKCRC
will review their work on an annual     Governance Forum will provide      projects such as the People in
basis to assess whether there is a      a forum to share information,      Research website
continued need for their activity.      identify issues and develop
                                        solutions to streamline the      ► The Health Research Analysis
In 2010 work will be taken forward      regulatory and governance          Forum, chaired by the Medical
as follows:                             environment. The Forum will        Research Council, has
                                        be chaired by an academic          responsibility for the Health
► A new Clinical Research               researcher and supported by        Research Classification System
  Funders Group will promote            the MRC Regulatory Support         and is considering future
  communication and alignment           Centre                             joint health research analysis
  of strategies between the UK                                             projects
  funders of clinical research, and   ► The UKCRC Industry Reference
  the providers of health services      Group, supported by the          ► The UKCRC Board Subgroup
  infrastructure and network            Department of Health, England,     on Public Awareness will
  support. The lead Partner in          will continue to provide high-     take forward a coordinated
  this area will be the Association     level strategic advice to the      programme of work to raise
  of Medical Research Charities         UKCRC Board and Government         awareness of the importance
                                        stakeholders on the needs          and value of the use of patient
                                        of the pharmaceutical,             data in research

Development of Model Agreements for Collaborative Commercial Research

A suite of model agreements are available to cover the              specialists. A report of this meeting is now available to
various clinical research scenarios in the health service           download from the UKCRC website at:
across the UK. They are designed to reduce the time,
effort and cost involved in negotiating acceptable terms
for an individual study between the health service and              http://www.ukcrc.org/regulationgovernance/
the study sponsor. When used without modification,                  modelagreements/commercialcollaborativeagree
these model agreements have been shown to reduce the
time and expense in setting up studies and they have
now been widely adopted.                                            Following the meeting, the National Institute for
                                                                    Health Research and the Medical Research Council
                                                                    have established a Working Group to take forward
In June 2009 the UKCRC held a workshop to assess the                the development of national model agreements for
need for, and explore the possibility of, developing model          collaborative commercial clinical research, including
agreements for collaborative commercial research.                   experimental medicine studies. The Working Group builds
                                                                    on the discussions at the workshop and established
                                                                    good practice. The Group is chaired by Professor William
The workshop was attended by key stakeholders,                      Rosenberg and has wide representation, including
including those from the pharmaceutical and devices                 members from the NHS, universities and industry.
industries, health services, universities and innovation

The Changing Regulatory and Governance Environment for Health Research
Across the UK - a Guide for Researchers

                                                                    The booklet describes the introduction of the Integrated
                                                                    Research Application System (IRAS) and its use as the
                                                                    preferred system for all applications for permissions
                                                                    and approvals, including ethics review and Research
                                                                    and Development (R&D) permissions across the UK.
                                                                    Information on the UKCRC R&G Advice Service, model
                                                                    agreements and the Research Passport is also provided,
                                regulatory and
                      The changing                                  along with sources of further information.
                      governance environment
                    for health research across the UK

                                   a guide for researchers
                                                November 2009 v.1
                                                                    The initiatives described in the booklet have been made
                                                                    possible by an ambitious programme of collaborative
                                                                    work involving many organisations. Whilst there is
In November 2009 the UKCRC published a booklet for                  still more to be done, the booklet demonstrates the
researchers describing the initiatives that have been put           considerable progress that has been made in addressing
in place by Partners and stakeholders to streamline the             many of the issues that were having a detrimental effect
regulatory and governance (R&G) environment across the              on health research in the UK.
                                                                    The booklet can be downloaded from the UKCRC website
It provides an overview of how the clinical research                at:
landscape has been dramatically transformed in recent               http://www.ukcrc.org/index.aspx?o=3058.
years with the introduction of a range of measures
intended to reduce bureaucracy, support world class
research and ultimately benefit patients.

A Critical Assessment of the Development of Patient and Public Involvement in
the UK Clinical Research Collaboration: Lesson Learned

In 2009, in response to plans for the transition to a                         assessment goes on to identify a series of lessons that
Partner-led UKCRC, the Board Subgroup for Patient and                         can be learned from the UKCRC’s PPI experience. In the
Public Involvement (PPI) commissioned a project to                            report these are grouped under three key themes:
identify and share lessons learned from the experience
of developing PPI in the Collaboration. The primary
audience for this assessment is people who have a                             What to think about when developing PPI
responsibility for taking forward PPI within a research                       ► Make PPI an early priority
                                                                              ► Identify clear aims and develop a shared
                                                                                    understanding of PPI
The project was carried out by TwoCan Associates                              ► Ensure you have dedicated resources and the right
between August and November 2009. Methods used                                      staff as early as possible
                                                                              ► Develop a strategy that has broad ownership, but
                                                                                    also directs coordinated action
► A review of relevant internal documents                                     ► Develop a programme of work that allows for both
► Development of a timeline of activity and key                                     quick wins and for long-term developments
    milestones                                                                ► Ensure that the PPI-related activity is visible and
► Individual and group interviews with key stakeholders                             adds value to other activities

► A survey of the UKCRC Board members                                         ► Demonstrate good practice, model high quality PPI
                                                                                    and report what you have done, so that others are
                                                                                    encouraged to do likewise
                                                                              ► Consider how you will measure any impact of PPI
                                                                                    when you are at the planning stages

              A critical assessment of the development of
                 patient and public involvement in the
                  UK Clinical Research Collaboration:

                     Lessons learned                                          Building relationships
                                                                              ► Ensure you have senior level commitment
                                                                              ► Build strategic alliances
                                                                              ► Keep sight of the bigger picture and don’t consider
                                                                                    PPI to be the only issue of importance
                                                Report by TwoCan Associates
                                                            November 2009
                                                                              ► Develop positive strategies to challenge sceptics:
                                                                                      •	 Demonstrate how PPI can help research
                                                                                          organisations to achieve their goals
Carrying out the assessment proved challenging because                                •	 Introduce change at an appropriate pace
many different individuals were involved over time, both
working alone and within various groups and committees.
It is also widely acknowledged that assessing the                             Be realistic
impact of any such complex social intervention can
be challenging. The assessment analysed the context                           ► About what can be achieved
of each key milestone and identified the factors that                         ► About the time it takes to achieve a culture change
either hindered or facilitated advancement of PPI. It also
assessed the outcomes at each stage and the overall
impact on the UKCRC and its Partners.                                         The Lessons Learned Report is being disseminated to
                                                                              and beyond the UKCRC’s Partner organisations and is
                                                                              available to download from the UKCRC website:
The resulting report identifies a number of impacts of
PPI on the UKCRC, such as changes in Board members’
attitudes, and on its Partner organisations, such as taking                   http://www.ukcrc.org/patientsandpublic/ppi/
learning from the UKCRC into Partner organisations. The                       understandingppi/

European Commission Announces Consultation on the “Clinical Trials Directive”

In December 2008 the European             the global dimensions of clinical        Further information can be found at
Commission announced that an              trials into account.                     the following link:
assessment would be made of the
“Clinical Trials Directive”. This
assessment would consider, in             The Commission has now published
particular, various options for further   its document Assessment of the
improving the functioning of the          functioning of the “Clinical Trials
Directive with a view to remedy           Directive” 2001/20/EC – Public
shortcomings and unintended               Consultation Paper. The consultation
negative consequences while taking        period will last until 8 January 2010.

  Update on the Registration of UK Clinical Trials Units

 The UKCRC Registration Process           The CTUs were required to meet a         Those units that met all of the
 for Clinical Trials Units (CTUs) is      number of key competencies, which        criteria received Full Registration,
 intended to raise standards and          were assessed against detailed           while others which did not yet
 improving the quantity and quality       evaluation criteria. These included      meet all the criteria were awarded
 of available expertise in the design,    a track record of experience in          Provisional Registration. The full list
 conduct and analysis of clinical         coordinating multi-centre clinical       of successful clinical trials units is
 trials. Ten CTUs across the UK have      trials, presence of expert staff and     now available on the UKCRC CTU
 recently been registered as part of      robust quality assurance systems,        website at:
 the latest round of this process. The    and evidence of long term viability
 new units join a network of CTUs         of capacity for trials coordination.
 that were registered following the       The registration process was             http://www.ukcrc-ctu.org.uk/
 first round in 2007. The network         coordinated by the National Institute
 now has a total of 49 registered         for Health Research Clinical
 units.                                   Research Network Coordinating
                                          Centre on behalf of the UK Clinical
                                          Research Collaboration.

UKCRC Website Updated

The UKCRC website has been further updated and redesigned to provide enhanced information on all areas of
UKCRC activity under the new way of working.
For further details see: http://www.ukcrc.org

Further information
Wider stakeholders involvement to identify key issues and take part in the development of solutions is crucial to
achieving the UKCRC vision. Because of the wide range of sectors involved in this Partnership, the most effective
way of engaging with the Collaboration will be through the Partner organisations of the UKCRC.
Further information can be obtained from the UKCRC Website or by contacting the UKCRC at:
UK Clinical Research Collaboration
20 Park Crescent
T: +44 (0)20 7670 5452
F: +44 (0)20 7637 6067
E: info@ukcrc.org

                                         Working in Partnership


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