Sept. 9 — It is a “total misfire” to pit randomized controlled trials against the use of real-world evidence as methods for evaluating new medical products for patients, FDA Commissioner Robert M. Califf said Sept. 8.
The commissioner of the Food and Drug Administration was addressing a move to incorporate real-world evidence, or data captured in routine medical care or from the patient directly, into the agency's regulatory decision-making process. Real-world evidence language appears in both the House-passed 21st Century Cures bill (H.R. 6) and the Senate's companion medical innovation effort to accelerate the development of new drugs and devices. 
The final agreement for the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) also includes incorporation of real-world evidence.
Proponents of adopting real-world evidence mechanisms, such as the Bipartisan Policy Center, say incorporating real-world data can address concerns about the $2 billion, decade-long effort it takes to develop a new drug, much of which is consumed by clinical trials. But groups like Public Citizen say moving away from the controlled clinical trial environment would mean increased risk to patients (10 LSLR 14, 7/8/16).
Califf's remarks responded to a question to identify the greatest challenges to and opportunities for using real-world evidence “to supplement, and in some cases substitute, for gold standard, randomized controlled clinical trials,” during Research!America's national health research forum.