Should oversight of US gene therapy trials change?

18 March 2012

As the number of gene therapy trials continues to expand, with more than 1150 separate trials in progress in the US alone, American gene therapy experts have said it is time to moderate regulatory oversight.
Currently, gene therapy clinical trials in the US require review by the federal Recombinant DNA Advisory Committee (RAC), in addition to Food and Drug Administration (FDA) and local bioethics and biosafety committee approval. The American Society of Gene and Cell Therapy (ASGCT) now says that as key safety concerns about gene therapy have not been realised, the RAC ‘would serve a more effective function’ by a focus on new areas of research and wider issues, rather than the review of individual protocols.
However, RAC chair Yuman Fong said that, whilst discussion would be useful, maintaining public trust in gene therapy remained very important, adding: "To go from reviewing most things to reviewing nothing is a big step".

Comment: In the UK, oversight of gene therapy trials has already moved from the governmental Gene Therapy Advisory Committee to within the National Research Ethics Service (NRES). It may be that a similar move is appropriate in the US as gene therapy is increasingly a mainstream form of clinical research.

However, maintaining public trust that safety is carefully monitored is indeed crucial; such trials often involve very ill people receiving experimental therapies, and deaths can occur, but if these are perceived to have been through a failure to observe safety protocols (as in the case of Jesse Gelsinger in 1999), the whole field can suffer. 

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