NIH and FDA Seek Feedback on Clinical Trial Protocol Template


I’d like to call your attention to an opportunity to provide comments on a proposed clinical trial protocol template, developed by the FDA and NIH, and informed by the guidance set forth by the International Conference on Harmonisation (ICH) E6 Good Clinical Practice.

The template provides a standard format, and corresponding instructions and sample text, for NIH-funded investigators to use when preparing protocols for phase 2 or 3 clinical trials that require an Investigational New Drug application (IND) or Investigational Device Exemption (IDE) application. It not only aims to help researchers address key details that should be included in clinical trial protocols, but also help researchers develop an organized document that will expedite both peer review and regulatory review processes.

NIH and FDA will be accepting responses through April 17. Comments must be submitted as described in the NIH Guide notice for consideration by the NIH-FDA Joint Leadership Council.

You may also be interested in reading blog posts by Dr. Carrie Wolinetz, NIH’s associate director of science policy, and Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, for more information on the development and goals of this proposed clinical trial protocol template.

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