Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real-world evidence (RWE) in the evaluation of new treatments, products, devices or for new uses.
The following list of open-access resources written in collaboration with FDA Commissioner Robert Califf and Kaiser Permanente Investigator Gregory Simon provide an overview of RWE for use in evaluating new medical treatments.
When Are Treatment Blinding and Treatment Standardization Necessary in Real-World Clinical Trials?
When Can We Rely on Real-World Evidence to Evaluate
New Medical Treatments?
When Can Nonrandomized Studies Support Valid Inference Regarding Effectiveness or Safety of New Medical Treatments?
When Can We Trust Real-World Data to Evaluate
New Medical Treatments?
Examining the Impact of Real-World Evidence on Medical Product Development
