Real-World Evidence Should Be Used in Regulatory Decisions About New Pharmaceutical and Medical Device Products for Diabetes.
Randomized clinical trials (RCTs) are no longer the sole source of data to inform guidelines, regulatory, and policy decisions. Real-world data (RWD), collected from registries, electronic health records, insurance claims, pharmacy records, social media, and sensor outputs from devices form real-world evidence (RWE), which can supplement evidence from RCTs. Benefits of using RWE include less time and cost to produce meaningful data; the ability to capture additional information, including social determinants of health that can impact health outcomes; detection of uncommon adverse events; and the potential to apply machine learning and artificial intelligence to the delivery of health care. Overall, combining data from RCTs and RWE would allow regulators to make ongoing and more evidence-based decisions in approving and monitoring products for diabetes.
['Klonoff|David C|DC|', 'Gutierrez|Alberto|A|', 'Fleming|Alexander|A|', 'Kerr|David|D|']
D003657:Decision Making D018795:Device Approval D003920:Diabetes Mellitus D004864:Equipment and Supplies D019317:Evidence-Based Medicine D006291:Health Policy D006801:Humans D004364:Pharmaceutical Preparations D016032:Randomized Controlled Trials as Topic
real-world evidence diabetes randomized clinical trials regulatory approval