US FDA seeks to “modernise” clinical trials with new draft guidance

New draft guidance for clinical trials has been issued by the FDA

The US Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernising the design and conduct of clinical trials.

In a statement, the regulator said that the updates are intended to help pave the way for more efficient clinical trials to facilitate the development of medical products, with an aim to be “more agile without compromising data integrity or participant protections”.

The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline that was developed to enable the incorporation of rapidly developing technological and methodological innovations into the clinical trial enterprise.

“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,” said FDA commissioner Robert M Califf. “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.”

GCPs 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 COVID-19 pandemic highlighted many of these challenges, while also spurring the development of new approaches, FDA’s statement adds.

“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 finalised, will encourage thoughtful approaches to conducting clinical trials with a focus on participant safety and data integrity.”

ElZarrad led the ICH Expert Working Group in developing the ICH E6(R3) draft guideline. Academic clinical trial experts from various ICH member countries also played an important role in informing the work of the expert group.

This draft guidance, once finalised, would update the existing guidance titled, E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). The revised draft recommendations are designed to be applicable to a broad range of clinical trials including those with innovative design elements.

The draft guidance will be open for public comment for 60 days. The ICH Expert Working Group will review and consider comments on this draft guidance, as well as feedback from other ICH member countries before finalising the ICH guideline.


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