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A Question Of Intent: How To Avoid US FDA Pitfalls With Academic Oncology Trials

 
• By Michael McCaughan

Academic oncology centers and commercial sponsors should work together to ensure that studies begun without ‘registrational intent’ can nevertheless work for US FDA’s needs if circumstances change, a multi-stakeholder white paper urges.

pitfalls in cancer research
• Source: Shutterstock

Biopharma companies should proactively plan for the possibility that academic trials involving their products begun without “registrational intent” could nevertheless generate data that ends up being submitted to the US Food & Drug Administration, a Friends of Cancer research white paper advises.

Key Takeaways

  • Trial sponsors should communicate with FDA as quickly as possible when they realize an academic trial may have a regulatory goal after all.

    • ...

The white paper, developed by a multi-stakeholder panel that included FDA input, was one of a series prepared for the organization’s annual meeting in November. (Also see "Patient...

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