“An expert is one who knows more and more about less and less until he knows absolutely everything about nothing.”

What’s New in GCP?

Reprinted from the Guide to Good Clinical Practice with permission of Thompson Publishing Group, 805 15th St., Washington, D.C. 20005; www.thompson.com. To learn more about the Guide to Good Clinical Practice, visit: www.firstclinical.com/gcpguide. In a draft guidance released June 18, the FDA clarified the factors it uses to assess the risks and anticipated benefits for device studies and how uncertainty can be offset by risk mitigation measures. “FDA believes use of this benefit-risk framework in an [Investigational Device Exemption (IDE)] application will facilitate the incorporation of evidence and knowledge from different domains — clinical, non-clinical and patient — to support a comprehensive, balanced decision-making approach,” the guidance says. “FDA envisions this will facilitate a common understanding between FDA and sponsors/sponsor-investigators by highlighting which factors are critical in the benefit-risk assessment for a specific application, and clearly explaining how these factors influence a regulatory decision. FDA also believes implementation of this guidance document will improve the predictability, consistency and transparency of the review process for IDE applications.” The FDA will disapprove an IDE if “‘[t]here is reason to believe that the risks to the subjects are not outweighed by the anticipated benefits to the subjects and the importance of the knowledge to be gained’ [21 C.F.R. §812.30(b)(4)]. In many cases, the agency believes that effective risk management, including the application of risk controls and risk mitigation measures, can result in a favorable IDE benefit-risk determination.” The guidance said the informed consent process is a “key tenet of FDA’s IDE benefit-risk framework,” as it provides “adequate information about the study, including pertinent information about the investigational device, its risk and benefits, alternatives and what is expected of the subject” in the study. The subject “must be given sufficient opportunity to consider whether or not to participate in the clinical study under circumstances that minimize the possibility of coercion or undue influence” (21 C.F.R. §50.20).


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