Drug-Induced Liver Injury Workshop Offers More Questions Than Answers
To fully understand an experimental drug's potential for liver toxicity, clinical trials should be better designed to reflect real-world populations, including patients with liver disease, but neither FDA nor experts from industry and academia at a recent workshop on the topic were able to provide many answers on how to do so safely
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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.
Subjects with psychiatric conditions are often excluded from trials, an agency study finds, which “doesn’t seem a good thing” to Bob Temple.