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Clinical Trial Sponsors Take Heed: Study Disclosure Rules Are Expanding

Executive Summary

The recent update of Title VIII of the Food and Drug Administration Amendments Act of 2007 clarifies the requirements for registering clinical trials and disclosing  trial results to US FDA, but many trial sponsors and investigators are still confused about their obligations under these rules, as well as the rules governing clinical trial registration and disclosure abroad. Francine Lane, the VP of global transparency at TrialScope, talked to Medtech Insight about the challenges facing clinical trial sponsors trying to comply with these rules and offered some predictions about how these regulations will likely evolve in the future.

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