Proposed ICH E6 Update Nets 1,300 Comments, Likely Delayed Until 2022
The International Council on Harmonization (ICH) said the third revision of its good clinical practice guideline will likely be delayed into 2022 as the group wades through 1,300 comments from the public about the revision.
Lisbeth Bregnhøj, GCP inspector at the Danish Health and Medicines Authority, said comments received indicate stakeholders want the ICH to identify ways in which clinical trial participants can take a more active role in trials; to consider sharing trial results with participants; and to clarify or update adverse event reporting recommendations.
She said stakeholders also want ICH E6(R3) to address new technologies, clinical trial designs and data types, such as from wearables and artificial intelligence. Stakeholders also complained that some areas of the proposed guidance lack detail — including in data management, the review of safety data, the use of data monitoring or adjudication committees, and informed consent.
The ICH gave a peek into its E6(R3) draft last month (CenterWatch Weekly, April 26). The public will have another chance to comment when the draft guideline is released.