What’s New in GCP?

FDA Clarifies Risk-Benefit Factors, Risk Mitigation for Device Studies  

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   In a draft guidance released June 18, the FDA clarified the factors it uses to assess the risks   and anticipated benefits for device studies and how uncertainty can be offset by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).