FDA Announces ICH E6(R3) Open Comment Period

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06/14/2023

Photo by Konstantin Planinski on Unsplash

The U.S. Food and Drug Administration (FDA) announced that the ICH E6(R3) Good Clinical Practice draft guidance is available for comments. This draft includes the GCP Principles and Annex 1, and the ICH Working Group is updating Annex 2.

“These draft recommendations were developed with the aim to streamline trials, making them more efficient and flexible as the trial enterprise continues to evolve,” said M. Khair ElZarrad, director of the FDA’s Center for Drug Evaluation and Research’s Office of Medical Policy. “We hope these recommendations, once finalized, will encourage thoughtful approaches to conducting clinical trials with a focus on participant safety and data integrity.” ElZarrad led the ICH Expert Working Group for ICH E6(R3).

One main objective in revising the GCP guideline was to interweave themes from ICH E8(R1) General Considerations for Clinical Studies guideline throughout, including Quality by Design (QbD) - building quality into the study design, identifying factors that are Critical to Quality (CtQ), engaging stakeholders early and throughout the clinical trial process, using a proportionate risk based approach to quality management, and cultivating a culture of quality.

See our blogs for other clinical trials modernization initiatives from the FDA include:

• Decentralized clinical trials

• Digital Health Technologies in Drug and Biological Product Development

• Real World Data and Real World Evidence Guidance:

  • Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products

  • Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision Making for Drug and Biological Products

  • Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products

  • Data Standards for Drug and Biological Product Submissions Containing Real-World Data

  • Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products

  • FDA Framework for Real World Evidence

Comment on the draft GCP guidance now through September 6, 2023 HERE.

The Annex 2 concept paper was approved May 2023. Content that will be added to the ICH E6(R3) guideline will include additional considerations for interventional clinical trials including:

• Decentralized clinical trials

• Pragmatic clinical trials (similar to routine clinical practice)

• Real world data

In approximately 12-18 months, the draft of Annex 2 will be released for public consultation through ICH, and the FDA is expected to release their draft guidance soon after for comments.

Need training for your team? Clinical Pathways offers Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline eLearning and live training.

This interactive eLearning course covers the importance of ICH and why a revision to E8 was needed, overarching themes of changes, the introduction of Quality by Design and Critical to Quality applied to clinical trials, an overview of the sections of the Guideline, and scenarios.

The course is available for purchase HERE.

Interested in GCP training on the latest revision? Sign up for our newsletter to keep in the know! Clinical Pathways will roll out the updated training soon after the guideline is finalized. Email us at info@clinicalpathwaysresearch.com for more information.

- The Clinical Pathways Team

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