Comment from The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center)
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Summary: The Multi-Regional Clinical Trials Center (MRCT Center) of Brigham and Women's Hospital and Harvard supports the FDA's effort to extend master protocol guidance beyond the COVID-19 pandemic. They provide specific feedback on definitions, scope, informed consent, and data sharing, while requesting further clarification on rare disease trials and multi-national considerations.
The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) appreciates the opportunity to comment, attached here.