1. NETSCC & CTU Support Funding UKCRC Registered CTU Network Annual Director’s Meeting November 2012 Liz Tremain

2. “Clinical Trials Units are central to our vision of expanding clinical trials in this country". Professor Dame Sally C Davies Chief Medical Officer & Chief Scientific Adviser, Department of Health

3. Background Introduced by the NIHR (2008) to strengthen the capacity for conducting clinical trials within the NHS and for delivery of the quality research projects required by the NIHR. Flexible use – limited rules: intended to provide additional stability and flexibility, allow units to recruit and retain key staff, and encourage an increase in high quality applications to NIHR programmes and funded trials. Expected result – increase in the volume of high quality research applications submitted to NIHR and funded trials supported.

4. Funding awarded to units with a demonstrated track record in conducting publicly-funded pragmatic clinical trials. Funding is an ‘advance’ - partly offset against future NIHR trial awards and recovery by reduction in future support funding payments (research grants unaffected). Units assessed annually to check on activity and progress. Key criteria for success – supporting NIHR trials and offset reported. Background

5. Key developments & progress 3 funding rounds completed to date. 20 UKCRC registered units (England) holding current awards. 2011 reporting data revealed;  Total outline applications supported - 222  Total full applications supported – 117  Total projects supported - 120  Total income arising from projects - £10.9 million  71.4 % of units reporting an offset  Average offset was 20.9% (range 2.3% - 77.8%)

6. Eligibility expanded to other NIHR programmes – RfPB, PGfAR, and i4i. Further funding opportunity for new units - November 2012. Rewarding progress - flexible offset & increased funding. NIHR Clinical Trials Fellowship scheme (led by NIHR TCC). Key developments & progress

7. Issues CTU capacity CTU collaboration Support from CTU host organisations

8. Next Steps Contract Review for existing units - December 2012. Successful units to be awarded 5 year contracts (2013-2018) Implementation of Annual Funding & Contract Review process No upper limit on funding – activity and offset returned will be key factors. Consolidation arrangements on an ‘institution’ basis and desire for more collaboration.

9. Other Key Activities UKCRC CTU Registration process. NIHR Clinical Trial Fellowship Scheme. New Clinical Trials Toolkit – launching late 2012. MHRA Risk Adapted Approaches.

10. Further information / enquiries Email: nihrctu@southampton.ac.uknihrctu@southampton.ac.uk http://www.netscc.ac.uk/supporting_research/CTUs/ Thank you