Modernizing Clinical Trials Requires Agility

The U.S. Food and Drug Administration (FDA) announced updated recommendations for good clinical practices (GCPs) to modernize the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections.

Proposed in June 2023, the draft guidance is adopted from the International Council for Harmonisation's (ICH) recently updated E6(R3) draft guideline developed to enable the incorporation of rapidly evolving technological and methodological innovations into the clinical trial enterprise. 

"A more robust clinical trial ecosystem capable of producing reliable evidence more efficiently may support more informed decision-making in developing medical products to help patients," said FDA Commissioner Robert M. Califf, M.D., in a press release.

"Building quality into the design and conduct of trials and encouraging the use of innovative trial designs and health technologies are essential to advance clinical trials and generate meaningful results truly."

GCPs are essential to help ensure the safety of trial participants, as well as the integrity of the data generated from trials.

Over the years, the clinical trial enterprise has been viewed as costly, inefficient, and constrained by inadequate collaboration and insufficient utilization of technology, data sources, and innovations in design and conduct.

The recent pandemic highlighted many of these challenges while spurring the development of new approaches. 

"These draft recommendations were developed to streamline trials, making them more efficient and flexible as the trial enterprise continues to evolve," commented 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 focusing on participant safety and data integrity."

This draft guidance, once finalized, would update the existing guidance titled E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (March 2018).

The revised draft recommendations are designed to apply to a broad range of clinical trials, including those with innovative design elements.

The modernized GCP recommendations also encourage using fit-for-purpose innovative digital health technologies (DHTs). DHTs, such as wearable sensors, could facilitate more agile data collection and assist with patient recruitment. 

The FDA recently issued other documents that complement these draft recommendations.

The agency supports adopting innovative trial designs when appropriate and releases draft guidance proposing recommendations for implementing decentralized clinical trials.

Regarding DHTs, the agency recently released a DHT framework document to guide DHT-derived data in regulatory decision-making for drugs and biological products. 

In addition to the recommendations supporting the modernization of trials, the principles outlined in the draft recommendations aim to make trials more efficient and potentially accelerate evidence generation for medical products.

This draft guidance will be open for public comment for 60 days as part of the FDA's established process. The ICH Expert Working Group will review and consider comments on this draft guidance and feedback from other ICH member countries before finalizing the ICH guideline.