Randomized controlled trials (RCTs) provide evidence for regulatory agencies, shape
clinical practice, influence formulary decisions, and have important implications for patients …

Regulators consider randomized controlled trials (RCTs) as the gold standard for evaluating
the safety and effectiveness of medications, but their costs, duration, and limited …

Objective There is increasing interest in conducting “Real-World” trials that go beyond
traditional assessment of efficacy and safety to examine market access and value for money …

Randomized control trials (RCTs) are required before drug and device approvals and have
contributed to patient safety, but they have also increased the cost and time of regulatory …

Purpose There is a need to develop hybrid trial methodology combining the best parts of
traditional randomized controlled trials (RCTs) and observational study designs to produce …

Real‐world evidence provides important information about the effects of medicines in
routine clinical practice. To engender trust that evidence generated for regulatory purposes …

Randomized controlled trials (RCTs) are preferred by payers for health technology
assessments and coverage decisions. However, the inclusion of a highly selective patient …

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navigation Frontiers in Pharmacology About us About us Who we are Mission Values History …

Real-world data and evidence provide the potential to address the effectiveness and safety
of drugs. The US Food & Drug Administration has initiated a program to evaluate the …

Recent legislation mandates that the US Food and Drug Administration issue guidance
regarding when real‐world evidence (RWE) could be used to support regulatory decision …