FDA updates recommendations to modernize design, conduct of clinical trials

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The U.S. Food and Drug Administration (FDA) on Tuesday released a draft guidance document with updated recommendations for good clinical practices aimed at modernizing the design and conduct of clinical trials.

The aim is to make clinical trials more agile without compromising data integrity or participant protections, the agency said.

“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,” FDA Commissioner Dr. Robert Califf said in a statement. “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.”

The updates are intended to help enable more efficient clinical trials to facilitate the development of medical products.

The draft guidance is adapted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline, which was developed to enable the incorporation of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

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