1. Protecting and promoting the interests of patients and the public in health research 1 MHRA / LRMN event The UK regulatory landscape in 2013 New GTAC arrangements and experience to-date Shaun Griffin 4 April 2013

2. HRA vision and ambition Protecting and promoting the interests of patients and the public in health research 2 Greater numbers of people can and do take part in health research, and continue to feel safe when they do Researchers find it easier to do high- quality, ethical research Less resource is invested in getting studies started Clinical trials are registered and research gets published The NHS appreciates the benefits of health research To make the UK a great place to do research, where more money invested in research goes into carrying out relevant, good quality research

3. Gene Therapy Advisory Committee – History The Committee had three main functions: (a) Carrying out a case-by-case review of individual study protocols (b) Reviewing more general issues relating to gene therapies (c) Providing advice to UK Health Ministers on developments in this field and their implications. Protecting and promoting the interests of patients and the public in health research 3

4. Gene Therapy Advisory Committee – History Rapidly evolving field Reviewed 13 proposals in its first year Developed guidelines for researchers e.g. on X-SCID gene therapy trials Issued a number of special reports e.g. on use of lentiviruses and retroviruses in clinical trials Protecting and promoting the interests of patients and the public in health research 4

5. GTAC – Transition November 2010 – Non-Departmental Public Body review GTAC already using systems used by existing NRES RECs – GTAC became IRAS partner; using NRES Research Ethics Database Need to conform to NRES Standard Operating Procedures Formally moved to NRES in July 2011 Protecting and promoting the interests of patients and the public in health research 5

6. GTAC – Current September 2012 – GTAC became a full NRES REC GTAC closed on 30 November 2012 UK Clinical Trials Regulations 2004 requires that there is a GTAC NRES Committee – West London and GTAC. Plus: York REC Oxford A Scotland A Protecting and promoting the interests of patients and the public in health research 6

7. GTAC – Changes Pre-application regulatory advice – available, but no longer necessary Scientific Review – sponsor’s responsibility Assurance to GTAC on science/safety – via MHRA Expert Advisory Group where appropriate Protecting and promoting the interests of patients and the public in health research 7

8. GTAC – Gaps and Improvements? What needs to be reviewed by GTAC? Gene therapy applications Stem cell therapy applications submitted to MHRA EAG No duplication but – scientific review and advice – where? 29 April GTAC Day – hosted by Catapult; attendees include BSGCT, HRA, HTA, MHRA, R&D Consider wider regulatory environment – e.g. DEFRA, HSE Protecting and promoting the interests of patients and the public in health research 8

9. GTAC – Improvements Increased availability of review slots from 6 to 44 per year Increased geographical spread – now four locations Improved timelines – 2012–2013: Pre-September 2012 – 8 studies: range 82–144 days Post-September 2012 – 6 studies: range 38–76 days KPI – HRA Business Plan – all studies < 60 days Protecting and promoting the interests of patients and the public in health research 9

10. HRA – Other initiatives IRAS improvements Hosted by HRA on behalf of partners, including MHRA HRA fundamental review to streamline information requirements IRAS will become an application and approvals system HRA assessment pilot Feasibility study of potential benefits of streamlined HRA assessment for all NHS research which would combine and replace aspects of the current review by NHS R&D and RECs Potentially improve study set-up times and the quality and consistency of review for all research projects Protecting and promoting the interests of patients and the public in health research 10

11. Contacts GTAC Bookings: 0845 2704400 Applications: nrescommittee.london-westlondon@nhs.net (email marked FAO Andrew George)nrescommittee.london-westlondon@nhs.net joan.kirkbride@nhs.net a.george@imperial.ac.uk HRA Communications hra.comms@nhs.net shaungriffin@nhs.netshaungriffin@nhs.net (2 days per week) gordon.harrison@nhs.net Protecting and promoting the interests of patients and the public in health research 11