FDA to Release Data on Gene Therapy Trials

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Science  26 Jan 2001:
Vol. 291, Issue 5504, pp. 572-573
DOI: 10.1126/science.291.5504.572B

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Moving to allay public concerns over the risks of controversial experimental procedures, the U.S. Food and Drug Administration last week proposed publicly releasing much of the safety and protocol data from clinical trials of gene therapy and animal-to-human transplants that it now keeps confidential. Several gene therapy researchers praised the decision, but biotech industry officials worry that releasing clinical data could stifle drug development and that the public may misinterpret the safety reports.