FDA seeks input on its trial oversight

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Aiming to ensure adequate protection of human subjects and the quality of clinical trial data, the FDA released draft guidance on the oversight of clinical investigations Aug. 29. The administration will accept public comment for 90 days on “Guidance for Industry Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring.”

Among the recommendations noted in the guidance, the FDA encourages greater reliance on centralized monitoring practices—with correspondingly less emphasis on onsite monitoring.

“In the past two decades, the number and complexity of clinical trials have grown dramatically. These changes create new challenges in clinical trial oversight such as increased variability in investigator experience, ethical oversight, site infrastructure, treatment choices, standards of healthcare and geographic dispersion,” the authors wrote.

The FDA noted a growing consensus favoring risk-based approaches to monitoring in order to improve safety and quality while allowing sponsors to monitor more effectively. “For example, incorporation of centralized monitoring practices, where appropriate, should improve a sponsor’s ability to ensure the quality and integrity of clinical trial data.”

In articulating its intent to facilitate wider use of alternative monitoring approaches, the agency noted several steps it has implemented, including:

  • Has withdrawn the 1988 guidance on monitoring of clinical investigations;
  • Is issuing this draft guidance encouraging risk-based monitoring approaches, including adoption of alternative monitoring methods;
  • Will ensure that the bioresearch monitoring compliance program guidance manuals for sponsors, contract research organizations, and clinical investigators and sponsor-investigators are compatible with the approaches described in this guidance;
  • Will ensure that all affected program areas within FDA are aware of the goals and purposes of this guidance and its compatibility with current compliance program guidance manuals; and
  • Will consider establishing processes within the Center for Drug Evaluation and Research for sponsors to voluntarily and prospectively submit and receive feedback on proposed monitoring plans. Sponsors of investigational device exemption (IDE) studies wishing to solicit feedback on their monitoring procedures prior to the submission of the IDE application may either submit a pre-IDE, or contact the FDA's Center for Devices and Radiologic Health’s division of bioresearch monitoring.