FDAnews Drug Daily Bulletin

ICH to Renovate Good Clinical Practice Guidelines

Jan. 25, 2017

The International Council for Harmonisation is taking public comments through March 11 on a paper proposing revisions to its good clinical practice guidelines, covering clinical trial design, management and conduct. The renovations include the E8 General Considerations for Clinical Trials guideline and the second revision of the E6 Guideline for Good Clinical Practice.

The ICH is considering incorporating risk-based clinical trials monitoring methods, as well as the use of real world evidence to inform regulatory decision making. Other potential applications of the E6 guideline include assessing the value and cost of drugs, comparative effectiveness research, and academic research. The council would also add annexes covering non-traditional trial designs.

The E8 guideline has not been updated since 1997. A revision would include the need to identify trial aspects and strategies critical to gathering reliable data and critical-to-quality factors.

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