FDA, NIH Seek Comments on Draft Clinical Trial Protocol Template

The FDA and the National Institutes of Health are seeking comments on a new draft clinical trial protocol template for NIH-funded investigators.

The template is intended to be used for Phase 2 or 3 clinical trial protocols that require IND or IDE applications.

The template was developed to standardize clinical trial protocols to help investigators plan better protocols to avoid trial delays. The agencies note that better designed trials will expedite the review process at both agencies.