Report: Ease Gene Therapy Reviews

The Institute of Medicine recommends relaxing the extra oversight given to gene therapy clinical trials.  

By | December 9, 2013

WIKIMEDIA, MAGGIE BARTLETT NHGRIFor nearly four decades, the National Institutes of Health has tasked a special committee with giving an added layer of oversight to gene therapy clinical trials. But as researchers have become experienced with the approach and more aware of potential risks, the Institute of Medicine (IOM) now suggests that this additional review is not needed in most cases. Rather, the committee could better apply its resources to emerging technologies for which far less is understood.

“Gene transfer research no longer stands alone as the only application for an emerging technology that might benefit from additional avenues of oversight. Nor is it even necessarily the one most deserving of such attention,” according to the report.

ScienceInsider noted that investigators testing gene therapies have considered reviews by the Recombinant DNA Advisory Committee a burden. Sharon Terry, president of the nonprofit Genetic Alliance in Washington, D.C. and a member of the IOM panel, told Nature:“We heard across the board that duplicity and different kinds of filings that scientists are responsible for are slowing down trials that should go forward.”

The IOM report does not recommend doing away with the committee altogether. In some gene therapy trial proposals, there should be extra oversight, such as in cases when the gene therapy protocol is novel, the preclinical data are based on an unfamiliar model system, or if there might be unknown toxicities. The experience of the committee could also serve as a model for dealing with new technologies.

According to ScienceInsider, NIH Director Francis Collins said in a statement that the agency “will be taking a close look at the study’s findings and recommendations and will determine the best path forward in light of our shared interest in doing what’s best for patients and for continued progress in the field.”

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Avatar of: Ken Pimple

Ken Pimple

Posts: 44

December 9, 2013

I doubt that Sharon Terry actually meant "We heard across the board that duplicity..." - surely she was talking about duplication. But it might be worthwhile to double-check with her.

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