In comments to the US Food and Drug Administration (FDA), pharmaceutical industry groups called for revisions to the International Council for Harmonisation’s (ICH) M11 guidance establishing a harmonized template for clinical trial protocols. The groups said the document should be revised to broaden the definition of a protocol, recommended that the use of estimands be justified in the protocol and include more examples of real-world data (RWD).
The guidance also includes a template for the format called the “Clinical Electronic Structured Harmonized Protocol (CeSHarP), as well as a set of specifications.
The draft guideline was released for comment in October 2022. FDA received 14 comments on the draft guidance. (RELATED: ICH releases M11 guideline proposing harmonized template for trial protocols, Regulatory Focus 25 October 2022)…
