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Clinical Trial Sponsors Take Heed: Study Disclosure Rules Are Expanding

 
• By Reed Miller

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.

Clinical Trial

Over the past two decades, sponsors of clinical trials have faced an expanding and evolving set of regulations governing the registration of clinical trials and the disclosure of certain information from those trials. In January, US FDA implemented a final rule detailing the requirements for submitting trial registration and summary results information to ClinicalTrials.gov, as required under Title VIII of the Food and Drug Administration Amendments Act of 2007. 

But the requirements are still confusing to many people in industry trying to comply with them, and the evolving rules governing trial disclosure and registration overseas create even more challenges for trial sponsors trying to meet all of their trial transparency legal obligations, according to Francine Lane, VP of global transparency

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