The FDA has issued new draft guidance to protect human subjects of clinical trials and the data these trials generate.
The draft guidance on using a risk-based approach to conducting clinical trials is one of a handful of guidances promulgated by the agency since FDA commissioner Dr. Scott Gottlieb announced his upcoming departure. In a new statement, Gottlieb said the agency wants to shake up the way clinical trials are conducted and light a fire under industry and academic trial sponsors who are stuck in their ways.
“Unfortunately, we’ve seen a continued reluctance to adopt innovative approaches among sponsors and clinical research organizations,” Gottileb said in the statement. “In some cases, the business model adopted by the clinical trial establishment just isn’t compatible with the kind of positive but disruptive changes that certain innovations can enable. We appreciate that scientific and technical complexity is a real and ongoing challenge, but industry and academia also need to invest in and leverage these approaches and develop new incentives that reward collaboration and data sharing across the clinical research enterprise.”
Gottlieb outlined an approach to lower the costs of conducting trials while encouraging collaboration, data sharing and patient enrollment. The FDA has been working with stakeholders including the Clinical Trial Transformation Initiative to identify innovative trial designs, evaluate the role of decentralized clinical trials and mobile technologies, and help validate novel endpoints that can help assess product safety and efficacy more efficiently.
The new draft guidance would update a 2013 final guidance that requires sponsors to monitor the conduct and progress of their trials but does not specify how to do it. The new proposal has recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. It would cover clinical investigations involving human drugs, biological products, medical devices and combinations thereof.
“This guidance can help sponsors tailor monitoring plans to the needs of the clinical investigation while focusing on those risks that have the greatest potential to adversely affect study quality,” Gottlieb said. “Risk-based monitoring can be advanced using computerized algorithms that enable remote and central trial monitoring, as well as the development of advanced analytics that can be used to monitor data integrity as a trial is in process.”
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