General Considerations for Clinical Studies E8(R1)

General Considerations for Clinical Studies E8(R1)

Уважаеми колеги,

 

ICH прие General Considerations for Clinical Studies E8(R1). ICH обобщава целите на ревизията по следния начин.

The revision of ICH E8 is expected to:

  •  Enhance the reliability of trial results through attention to trial quality
  • Better integrate overall design and planning with subject protection and data reliability considerations that are the focus of ICH E6, statistical considerations that are the focus of ICH E9, and other considerations addressed in other ICH Efficacy guidelines.
  • Enhance the utility of the ICH Efficacy guidelines by including critical-to-quality factors as a key consideration in planning and design of clinical trials
  • Promote the quality of trial design and conduct for a broad range of trial types and data sources with critical-to-quality factors aligned to the objectives of the trial

 

 

 

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