FDA Guidance Recommends Centralized IRB Review for Multicenter Trials
Investigators, sponsors and institutional review boards (IRBs) looking to reduce the time it takes to conduct multicenter clinical research should consider implementing a centralized IRB review process, suggests a new FDA draft guidance that describes how to initiate the review strategy.
In most multicenter trials, an IRB at each center typically conducts a complete review of the trial protocol and the informed consent process. Although this strategy can be used successfully, it isn't necessarily the best approach in today's research climate because the growing size and complexity of late-stage clinical trials has placed considerable burdens on IRBs, sponsors and investigators participating in multicenter studies, the FDA said.
"Multiple reviews by multiple IRBs can result in unnecessary duplication of effort, delays, and increased expenses in the conduct of multicenter clinical trials," says the guidance. "Greater reliance on a centralized IRB review process, in appropriate circumstances, has the potential to reduce IRB burdens and delays in the conduct of multicenter trials."
The FDA is accepting public comment on the document for 60 days. To view the draft guidance, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0103-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0103-gdl0001.pdf).
Upcoming Events
-
21Oct