FDA Releases New Guidelines for Oversight of Clinical Trials

This past week, the Food and Drug Administration released Guidance for Industry on “Oversight of Clinical Investigations – A Risk-Based Approach.”  The purpose of the Guidance is to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical studies of medical devices, human drug and/or biological products. While these guidelines are not mandatory, they do reflect the FDA’s thinking on the topic and are certainly industry-based recommendations.

In this new Guidance, the FDA describes strategies that reflect a modern, risk-based approach focusing on critical study parameters and rely on a combination of monitoring activities to oversee a study effectively.  For example, the FDA encourages greater use of centralized monitoring methods where appropriate. The FDA believes that risk-based monitoring could improve sponsor oversight of clinical investigations. 

Unlike on-site monitoring, which is an in-person evaluation carried out by sponsor personnel or representatives at the sites where the clinical investigation is being conducted, centralizing monitoring is carried out by sponsor personnel or representatives at a location rather than the site where the clinical investigation is being conducted (i.e., via electronic communication).  While sponsors may be wary about a change in their monitoring practices and possible associated cost, the FDA noted “that centralized monitoring activities could have identified more than 90% of the findings identified during the on-site monitoring visits.”  Advancements in technology may make centralized monitoring an option when a risk-based approach is used to develop the sponsor’s strategy.  Overall, the new FDA recommendations may be helpful to sponsors in developing and implementing new study-specific monitoring plans.

A copy of the FDA’s August 2013 Guidance is available, click here.

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