Diabetes Drug Developers Urged To Study Higher Risk Patients By FDA Panel
There is one message that sponsors should take to heart from an FDA advisory committee's first pass at applying new cardiovascular outcomes standards to type 2 diabetes medicines: enroll sicker patients in pivotal trials
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Stakeholders tell FDA it should force sponsors to recruit more diverse populations for its clinical trials by refusing to approve applications with inadequate data or expediting those with the necessary information.
Extension of the Clinical Trial Engagement Network is aimed at increased diversity in clinical trials, which is becoming increasingly important as more drugs are targeted at specific groups.
FDA’s Bob Temple says “document” being drafted will instruct reviewers to pay more attention during sponsor meetings and eliminate unnecessary exclusions from protocols.