GCP update: FDA opens clinical trial draft guidance for comments

The FDA this week released new draft guidance that aims to modernize clinical trials, with an update to the International Council for Harmonisation’s (ICH) overarching Good Clinical Practice (GCP) guidance, last updated in 2016.

GCPs are the internationally-recognized ethical, scientific and quality standards that human trials should adhere to, making any updates to the ICH guidance closely watched. In this latest round of reforms, the guidance offers new recommendations applicable to a broad range of trials including those with innovative design elements or digital health technologies.

The FDA said the 73 pages of modernized GCP recommendations encourage the use of new trial designs and fit-for-purpose digital health technologies, such as wearables or sensors, that could potentially facilitate more data collection and assist with patient recruitment. The agency also recently released a digital health tech framework to guide the use of this data in regulatory decision-making for drugs and biologics.

“The use of innovative clinical trial designs and technologies may help include diverse patient populations, as appropriate, and enable wider participation,” the draft says. “The design of the trial, to ensure appropriate quality and meaningful trial outcomes, may be supported by the perspectives of stakeholders; for example, patients and/or healthcare providers.”

Overall, the draft, known as ICH E6 (R3), makes the trial framework more flexible and is structured to provide guidance throughout the life cycle of the clinical trial.

M. Khair ElZarrad

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

On the innovative trial design side, the FDA in May also released draft guidance on decentralized clinical trials.

“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,” FDA commissioner Rob Califf said in a statement.

Those seeking to comment on the ICH guidance, released as an FDA draft, have until Sept. 6. ICH is made up of six founding members: FDA, industry group PhRMA, the European Commission, the European industry group, Japan’s Ministry of Health, Labour, and Welfare, and the Japanese Pharmaceutical Manufacturers Association. Standing members include Health Canada and Swissmedic.

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