FDA Proposes Updates to Clinical Trials

The drafted guidance would modernize the trials to be more efficient and reliable.

The U.S. Food and Drug Administration (FDA) has released a draft guidance that provides updated recommendations for good clinical practices (GCPs) in clinical trials. The goal is to modernize trial design and performance, making them more effective while maintaining participant safety and data integrity.

According to FDA Commissioner Robert Califf, “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.”

The FDA’s focus would encourage innovative trial designs, and technologies, and streamline processes. The guidance is based on the International Council for Harmonisation’s (ICH) updated draft guideline, which incorporates technological and methodological innovations in clinical trials.

M. Khair ElZarrad, director of the FDA’s Center for Drug Evaluation and Research’s Office of Medical Policy stated, “We hope these recommendations, once finalized, will encourage thoughtful approaches to conducting clinical trials with a focus on participant safety and data integrity.”

As the Lord Leads, Pray with Us…

  • For Commissioner Califf as he seeks improvements in the design of clinical trials.
  • For FDA officials as they work on the modernization and efficiency of trials.
  • For Director ElZarrad as he heads the FDA’s Drug Evaluation and Research Office of Medical Policy.

Sources: Food and Drug Administration


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