FDA seeks feedback on ICH E6(R3) GCP guideline

The US Food and Drug Administration (FDA) has started its public consultation for the International Council for Harmonisation (ICH) guideline on good clinical practice (GCP) and has requested feedback on the guidance, which would help modernize clinical trials.

The ICH draft guideline was published in late May, and serves as an update for the E6(R2) version of the guideline that was adopted by the FDA in March 2018. Despite the E6(R2) covering the areas of emerging technology and electronic data sources, after its adoption, ICH decided to address innovative trial designs and diverse data sources in E6(R3). (RELATED: E6(R3): ICH releases draft of overhauled GCP guideline for consultation, Regulatory Focus 25 May 2023)

The goal of the E6(R3) draft guideline is to modernize clinical trial design and conduct and enable the introduction of “rapidly developing technological and methodological innovations” in clinical trials, according to the agency.

“A more robust clinical trial ecosystem that is capable of producing reliable evidence more efficiently may support more informed decision-making in developing medical products to help patients,” Robert Califf, MD, FDA Commissioner, stated in a press release. “These draft recommendations propose a major step forward in this work. Building quality into the design and conduct of trials and encouraging the use of innovative trial designs and health technologies are essential to truly advance clinical trials and generate meaningful results.”

E6(R3) aims to address a “broad range of clinical trials” to increase efficiency and lessen the burden of clinical trials, FDA said. It also details the use of digital health technologies (DHTs) like wearable sensors for data collection and patient recruitment.

FDA said the principles in the E6(R3) draft guideline are to emphasize using risk-based and proportionate approaches to clinical trial in collection of data, monitoring and quality management across the lifecycle. It encourages an approach to identify and focus on the data and clinical trial processes that most benefit participant safety and data integrity. Another main principle is empowering a sponsor to consider a trial’s quality and to do so proactively, which can include trial attributes that are “fundamental to the protection of participants, the reliability of trial results and the decisions made based on those trial results.”

These approaches have the potential to “accelerate evidence generation for medical products,” the agency said, while optimizing the efficient design of trials and lessening trial delays.

Recently, the agency released documents related to the E6(R3) draft guideline, such as its draft guidance with proposed recommendations on implementing decentralized clinical trials and its framework document on use of DHTs in clinical trials evaluating drugs and biologics (RELATED: FDA issues draft guidance on decentralized clinical trials, Regulatory Focus 02 May 2023; FDA outlines plan for digital health technologies for clinical trials, Regulatory Focus 24 March 2023).

“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 Center for Drug Evaluation and Research’s Office of Medical Policy. ElZarrad was the rapporteur for the ICH E6(R3) working group.

“We hope these recommendations, once finalized, will encourage thoughtful approaches to conducting clinical trials with a focus on participant safety and data integrity,” ElZarrad said.

Draft guidance

FDA seeks feedback on ICH E6(R3) GCP guideline

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