ICH E8 under revision

The ICH Guideline “General Considerations for Clinical Trials” is under revision and has been issued for public comments

ICH is proposing a modernization of ICH E8 in order to incorporate the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials. The revision would propose to: identify a basic set of critical-to-quality factors that can be adapted to different types of trials to support the meaningfulness and reliability of trial results and to protect human subjects; address a broader range of trial designs and data sources; and provide an updated cross-referencing of all other relevant ICH Guidelines that should be referred to when planning clinical studies.

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