A regulatory system for approving new drugs is certainly necessary, says In the Pipeline's Derek Lowe, but is it the right system? Lowe references an article at BioCentury that suggests an adaptive system instead of one that makes binary decisions. In other words, Lowe says, the idea is to set things up so that data can be generated quickly, that decisions can be made on that data, and then modified when additional findings come out. Biomarkers should also be an important part of early-phase clinical work, he says, as should the wider use of conditional approvals and adaptive clinical trials. "Another way to speed things up with adaptive designs would be to run several new therapies in a given space simultaneously, re-assigning patients as the more effective candidates show themselves," Lowe adds. "If the trials are going on continuously, the barriers to getting in on them would be lower than they are under the current system, where everyone has to start their own work from the ground up." It would be a big adjustment to make, but the ideas, he says, have merit, and should be given more scrutiny.
Suggestions for Drug Approvals
Sep 14, 2010