NETSCC & CTU Support Funding

UKCRC Registered CTU Network Annual Director’s Meeting November 2012

Liz Tremain

“Clinical Trials Units are central to our vision of expanding clinical trials in

this country".

Professor Dame Sally C DaviesChief Medical Officer & Chief Scientific Adviser, Department of Health

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.

• 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

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%)

• 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

Issues

• CTU capacity

• CTU collaboration

• Support from CTU host organisations

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.

Other Key Activities

• UKCRC CTU Registration process.

• NIHR Clinical Trial Fellowship Scheme.

• New Clinical Trials Toolkit – launching late 2012.

• MHRA Risk Adapted Approaches.

Further information / enquiries

Email: nihrctu@southampton.ac.uk

http://www.netscc.ac.uk/supporting_research/CTUs/

Thank you