Observational Studies Should Get Safe Harbor For Preregistering Protocols – Humana

Payors could get more faith in real world data  – and sponsors might get more protections for disseminating them – if ISPOR/ISPE task force recommendations are adopted by industry and US FDA.

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Drug treatment studies based on observational data should be able to benefit from the US FDA's proposed safe harbor for communications to payers if manufacturers publicly register their protocols ahead of time, Humana Inc. Chief Pharmacy Officer Laura Happe suggested.

Happe's remarks came at a conference on standards for real world evidence sponsored by the International Society for Pharmacoeconomics and...

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