Gene therapy proposals

In June, a US working group that reviewed NIH's system for overseeing gene therapy and transfering clinical protocols recommended an approach to bring the NIH Recombinant DNA Advisory Committee (RAC) more fully into that process without formally voting on the acceptability of proposals as it once did. Thus, investigators may be asked to respond to RAC-voiced concerns while they also meet the formal Investigational New Drug requirements of the FDA. However, members of the group, which was cochaired by Christine Cassel of the Mount Sinai Medical Center (New York) and Stuart Orkin of Harvard Medical School (Boston, MA), could not fully agree on how or whether to change the reporting of serious adverse events arising from such clinical trials. In general, according to Orkin, the group recommends that federal officials find some way to harmonize the timetables specifying when investigators and sponsors are required to transmit information about adverse events to FDA and NIH. Moreover, he says most review group members also agree that raw data about such events should be withheld from the public, which would be better served by reports that provide analyzed information in an appropriate context.

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Fox, J. Gene therapy proposals. Nat Biotechnol 18, 700 (2000). https://doi.org/10.1038/77196

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