Enrollment Data Can Be Signal to IRB of Other Problems

IRBs conducting continuing review of research should look at enrollment issues as an indicator of other problems with studies, a new draft guidance says. A marked difference between expected and actual enrollment rates, for instance, may indicate a problem that requires further evaluation, including whether the study is likely to provide enough data, according to the draft guidance posted this month by the HHS Office for Human Research Protections.
Clinical Trials Advisor