Gene Therapy Advisory Committee (GTAC)

The Gene Therapy Advisory Committee (GTAC) moved to the HRA’s National Research Ethics Service in July 2011. The move, resulting from the Government’s Arms-length bodies review NDPB review in 2010 meant that GTAC no longer needed to provide advice to Ministers; and responsibility for it would move away from the Department of Health. As the UK Clinical Trials Regulations 2004 requires that there is a GTAC, the HRA, as the appointing authority for GTAC, nominated an existing Research Ethics Committee to take on GTAC’s functions. This new committee is now called West London and GTAC. The three other committees are in York, Oxford and Scotland.

These changes have:

  • Increased availability of review slots from 6 to 44 per year
  • Increased geographical spread – now four locations for submitting applications.

GTAC processes are now consistent with those of other RECs. The time taken for approvals made has reduced by more than half. The last approvals before the HRA took responsibility took 93.5 days; the most recent approval since the transfer took 39 days. The graph below demonstrates the reduction in time taken for approvals since GTAC’s move to the HRA.

graph

During GTAC’s transition to HRA, we clarified the respective roles of MHRA and GTAC, particularly around review of science and timelines.

Andrew George is Alternate Vice Chair of West London and GTAC. Mary Collins is an expert advisor on Oxford Committee.

 

What needs to be submitted to GTAC?

Legally only gene therapy clinical trials need to be submitted to GTAC, but some stem cell studies like those submitted to the MHRA’s Expert Advisory Group (EAG) are also submitted. GTAC and MHRA are working together to draw up further guidance.

 

Support for new GTAC arrangements

Keith Thompson, Cell Therapy Catapult said: “The improving regulatory environment in the UK is a positive factor in discussions with potential inward investors and firms operating in the UK who are wanting to set up clinical trials in cell and gene therapy.”

Paul Whiting, Pfizer Neusantis, said: “We welcome the recent changes to GTAC, particularly the improved response times and the clearer focus of responsibility. This is a step in the right direction to enable regenerative medicine clinical research to prosper in the UK.”

 

More information

Applying to GTAC  

A presentation delivered to the London Regenerative Medicine network meeting on 4 April 2013 [powerpoint, 154kb]

2012-3 Annual Review – contains an article summarising HRA’s improvements to GTAC