☆ 4.3 Review

Real-World Data in the Postapproval Setting as Applied by the EMA and the US FDA

CLINICAL THERAPEUTICS (2022)

Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth

Hans-Georg Eichler et al.

Summary: Compared to drugs from the past, new drugs are more diverse, including chemicals, biologicals, and cell and gene therapies, mainly for rare diseases and personalized treatments. The changing nature of drugs has implications for definitions, clinical use, and evidence generation. In the future, drug evaluation will involve a combination of randomized controlled trials and real-world evidence for assessing safety and effectiveness.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2021)

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Article Cardiac & Cardiovascular Systems

Emulating Randomized Clinical Trials With Nonrandomized Real-World Evidence Studies First Results From the RCT DUPLICATE Initiative

Jessica M. Franklin et al.

Summary: The study found differences between RCT and corresponding RWE study populations, but showed that selecting active comparator therapies with similar indications and use patterns can enhance the validity of RWE. Despite efforts to closely emulate RCT design, agreement between RCT and RWE findings varied depending on the agreement metric used, indicating the need for further research to understand the frequency and contexts in which RWE findings match RCTs.

CIRCULATION (2021)

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Review Pharmacology & Pharmacy