The U.S. Food and Drug Administration (FDA) has released a draft guidance with updated recommendations for good clinical practices (GCPs) in an effort to modernize the design and conduct of clinical trials. The goal is to make clinical trials more agile and efficient without compromising data integrity or participant safety. The draft guidance is based on the International Council for Harmonisation’s (ICH) updated E6(R3) draft guideline, which aims to incorporate technological and methodological innovations into the clinical trial process.

The FDA believes that a more robust clinical trial ecosystem capable of producing reliable evidence efficiently will support better decision-making in developing medical products for patients. The draft recommendations propose a significant step forward in achieving this goal. The FDA Commissioner, Robert M. Califf, emphasizes the importance of building quality into trial design and conduct, as well as encouraging the use of innovative trial designs and health technologies to advance clinical trials and generate meaningful results. “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 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.”

Good clinical practices are crucial for ensuring participant safety and maintaining the integrity of trial data. However, the clinical trial enterprise has long been perceived as costly, inefficient, and lacking collaboration and technological utilization. The COVID-19 pandemic highlighted these challenges while also driving the development of new approaches.

The draft recommendations aim to streamline trials, enhancing their efficiency and flexibility as the trial enterprise evolves. Once finalized, these recommendations are expected to encourage thoughtful approaches to clinical trial conduct, with a focus on participant safety and data integrity.

Read the full text here.

References

  1. Office of the Commissioner. (2023). FDA Announces Additional Steps to Modernize Clinical Trials. U.S. Food And Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-announces-additional-steps-modernize-clinical-trials

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