RAC skeptical of safety board proposal

The Recombinant DNA Advisory Committee reacted skeptically to a proposal from a RAC working group to form a national data and safety monitoring board (DSMB) to review adverse events during gene therapy trials (see BioCentury Extra, March 8).

Many RAC members objected to the scope and timing of data submissions required under the proposal. They noted that the proposal would require investigators to immediately report to the RAC some data that is already reported to the FDA on an annual basis. Several RAC members also expressed confidence in the FDA's ability to interpret and act on adverse event reports. ...