Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable
Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable
There is growing interest in regulatory use of randomized pragmatic trials and noninterventional real-world (RW) studies of effectiveness and safety, but there is no agreed-on framework for assessing when this type of evidence is sufficiently reliable. Rather than impose a clinical trial-like paradigm on RW evidence, like blinded treatments or …