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FDA Developing Guidance on Clinical Trial Monitoring

NEW YORK (GenomeWeb News) – The US Food and Drug Administration wants clinical investigators from industry studying drugs, medical devices, and biological products to shift to a risk-based approach in monitoring their programs, according to a new draft guidance released today.

FDA will be taking public comments on the draft guidance, "Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring," through late November, when the agency plans to begin finalizing its guidelines.

FDA said that its aim is to ensure that investigators can "use a variety of approaches to meet their monitoring responsibilities" for clinical trials, and provides guidelines for instituting a "modern, risk-based approach" that relies on a combination of approaches. For example, FDA is encouraging sponsors of clinical studies to use more centralized monitoring methods, as opposed to on-site monitoring, and it provides recommendations about how to develop and implement such methods and plans.

Using centralized monitoring practices may "improve a sponsor's ability to ensure the quality and integrity of clinical trial data," FDA advised, because data anomalies such as fraud and data fabrication "may be more readily detected by centralized monitoring techniques than by on-site monitoring." New remote monitoring and source data verification tasks that traditionally required on-site monitoring may now be done remotely, in part due to new electronic data capture systems, the FDA noted.

"There is a growing consensus that risk-based approaches to monitoring, such as focusing on the most critical data elements, are more likely to ensure subject protection and overall study quality, and will permit sponsors to monitor the conduct of clinical investigations more effectively than routine visits to all clinical sites and 100 percent data verification," FDA explained.

The draft guidance also proposes that clinical trial sponsors should create monitoring plans and should perform risk assessments that consider the types of data that will be collected in a clinical trial, how those data are collected, and the range of potential safety and other protections concerns.

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