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Expanded Access Programs Eyed For Data-Gathering Purposes

 
• By Sue Sutter

Protocol-driven approach could generate reliable data about investigational drug's efficacy and safety in patients who do not qualify for clinical trials, PhRMA's Moscicki says; Johns Hopkins' Sharfstein cautions this could turn expanded access programs into burdensome studies that take away from primary purpose of providing access to investigational therapies.

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There appears to be growing momentum for designing expanded access programs to serve as data-gathering tools to learn more about investigational drugs' efficacy and safety.

Appropriately designed, protocol-driven expanded access programs, conducted in patient populations that are not covered by ongoing clinical trials, could generate data useful to the US FDA's evaluation of drug efficacy,...

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