FDA announces additional steps to modernise clinical trials

FDA

The US Food and Drug Administration has published draft guidance with updated recommendations for good clinical practices (GCPs) to modernise the design and conduct of clinical trials.

The updates are intended to help pave the way for more efficient clinical trials. The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline.

“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 Califf.

“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.”

Over the years, clinical trials have been viewed as costly, inefficient and constrained by inadequate collaboration and insufficient utilisation of technology, data sources and innovations in design and conduct.

“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.”

In May, the FDA released draft guidance proposing recommendations for the implementation of decentralised clinical trials. The agency also recently released a digital health technologies (DHT) framework document to guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

The draft guidance will be open for public comment for 60 days.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

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