An international guideline focused on building quality into clinical trials is now official FDA guidance. The agency last week published the International Council for Harmonization’s (ICH) E8(R1) — General Considerations for Clinical Studies as a final guidance, signaling its support for the “quality by design” concept.

The FDA guidance, which is largely the same as the draft guideline first published by the ICH in 2019, cements the agency’s position that clinical trials should be designed to focus on factors critical to quality (CenterWatch Weekly, Oct. 11, 2021).

“Quality factors should be prioritized to identify those that are critical to the study, at the time of the study design, and study procedures should be proportionate to the risks inherent … and the importance of the information collected,” the guidance says.

Read the final guidance here: https://bit.ly/3DWqWcp.