FDA: Patients with incurable cancer should be incl
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Posted On: 08/01/2022 11:33:19 AM
FDA: Patients with incurable cancer should be included in trials for new therapies
New final guidance released by the FDA recommends drug developers to include patients with incurable cancers in clinical trials for experimental therapies, though the guidance underscores the importance of informed consent before enrolling patients.
The guidance applies to cancer patients with locally advanced, unresectable or metastatic solid tumors and/or those with hematologic malignancies with unfavorable long-term overall survival, and the document recommends patients be allowed to participate in trials, even if they would otherwise be excluded based on study criteria.
https://www.raps.org/news-and-articles/news-a...ients-with
New final guidance released by the FDA recommends drug developers to include patients with incurable cancers in clinical trials for experimental therapies, though the guidance underscores the importance of informed consent before enrolling patients.
The guidance applies to cancer patients with locally advanced, unresectable or metastatic solid tumors and/or those with hematologic malignancies with unfavorable long-term overall survival, and the document recommends patients be allowed to participate in trials, even if they would otherwise be excluded based on study criteria.
https://www.raps.org/news-and-articles/news-a...ients-with
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