Modernization and patient protection at center of new US draft GCP guideline

New draft guidance will help modernize trials and make drug research more efficient while ensuring the protection of people who take part in studies according to the US FDA.

The US regulator published the document last week, explaining that the aim is to bring recommendations on good clinical practices (GCP) into alignment with the International Council for Harmonization's (ICH) recently updated E6(R3) draft guideline.

In particular, the US Food and Drug Administration (FDA) said, the guideline was developed to enable the incorporation of rapidly developing technological and methodological innovations into clinical trials.

FDA Commissioner Robert Califf stressed the important role that more streamlined and effective importance of drug research has in improving access to medicines.

“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.

“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.”

Flexibility

The FDA cited COVID-19 as a major impetus for development of the new guidelines, explaining disruption caused by during pandemic laid bare some of the inefficiencies and constraints that stymie drug research.

M. Khair ElZarrad, director of the FDA’s Center for Drug Evaluation and Research’s Office of Medical Policy – leader of the ICH Expert Working Group that developed the E6(R3) guideline – said the trials sector much learn to be adaptable to thrive.

“These draft recommendations were developed with the aim to streamline trials, making them more efficient and flexible as the trial enterprise continues to evolve.

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

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