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Public have right to see data from all gene trials, says FDA

Nature volume 409, page 442 (25 January 2001) | Download Citation

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The US Food and Drug Administration (FDA) last week put forward proposals to make clinical trials in gene therapy and xenotransplantation more transparent. The move drew support from some academic scientists, but criticism from the biotechnology industry.

The proposal — which interested parties have 90 days to comment on — would close a loophole that allows some data from privately funded trials to be concealed. Comments can be sent to fdadockets@oc.fda.gov .

Public disclosure became an issue in 1999, after a teenager died in a clinical trial at the University of Pennsylvania.

Adverse effects from federally funded gene-therapy trials are meant to be reported to the National Institutes of Health (NIH) and the FDA. But after the death, NIH investigators learnt that hundreds of such events had not been reported to the agency, which makes data public through the Recombinant DNA Advisory Committee (RAC). Most had only been reported to the FDA, which keeps them confidential. Researchers complained that the agencies had different reporting standards. Last week's announcement aims to harmonize those requirements, and expand them to xenotransplantation.

The new policy would ensure that data on adverse events from all gene-therapy trials would be made public. Some are already made public through an NIH database: the change would ensure that this database contains information from all ongoing trials.

Inder Verma, president of the American Society of Gene Therapy, applauds the FDA's proposal, describing it as necessary to regain public trust. “Anything that will make it a more open process is good,” says Verma, a Salk Institute gene therapy researcher.

Michael Werner of the Biotechnology Industry Organization (BIO), which opposes the proposal, says it raises privacy concerns. The BIO favours releasing aggregated safety data and reports on trends in adverse events rather than information about individual trials.

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https://doi.org/10.1038/35054199

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