Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 37, No. 10, Oct., 2022

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Here’s an inside look at what you will receive in the digital newsletter, including an additional excerpt, below. Click the image below for the first two pages of this issue.

Back Issue October 2022

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Excerpt from pg. 3 … IRBs and Special Cancer Research Subject Eligibility

With this article we begin, and end, covering the highlights of a recent final guidance from FDA titled “Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings.”

For IRBs, the primary use of this guidance is its descriptions of particular details on recruitment and enrollment of a special group of potential study subjects.

The guidance provides recommendations to sponsors of clinical trials of investigational cancer drugs regarding the inclusion of patients who have not previously received available therapy (commonly referred to as existing treatment options) for their cancer in the non-curative setting.

For purposes of this guidance, non-curative is generally defined as: (1) unresectable, locally advanced, or metastatic disease in solid tumors or (2) hematologic malignancies with unfavorable long-term overall survival (87 Fed. Reg. 45114, July 27).