FDA's new strategic framework to advance use of real-world evidence to support development of drugs and biologics

The health care system is integrating more effective ways to leverage electronic tools to gather and use vast amounts of health-related data, according to FDA Commissioner Scott Gottlieb. These tools offer new opportunities to use data collected during the routine care of patients to advance medical care.

The health care system is integrating more effective ways to leverage electronic tools to gather and use vast amounts of health-related data, according to FDA Commissioner Scott Gottlieb. These tools offer new opportunities to use data collected during the routine care of patients to advance medical care. Leveraging such real-world data (RWD) to improve regulatory decisions is a key strategic priority for FDA. on Thursday, the agency announced its new 2019 strategic framework for how it will continue to advance these opportunities. RWD collected from a variety of sources offer new opportunities to generate evidence and better understand clinical outcomes. These data are being used to develop information and real-world evidence (RWE) that can better inform regulatory decisions. RWD and RWE can be especially useful for postmarket monitoring of the safety of products during their use in real world settings. FDA is releasing a new, strategic, approach—the Framework for the Real-World Evidence Program, to apply across its drug and biologic review programs. This Framework is aimed at leveraging information gathered from patients and the medical community to inform and shape FDA's decisions across its drug and biologic development efforts. It will help FDA and industry evaluate the potential use of RWE to support regulatory decisions that have visible outcomes for consumers.