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

Purpose Real‐world evidence (RWE) includes data from retrospective or prospective
observational studies and observational registries and provides insights beyond those …

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

Objectives: Health decision‐makers involved with coverage and payment policies are
increasingly developing policies that seek information on “real‐world”(RW) outcomes …

Evidence generated by randomized controlled trials (RCTs) does not often represent the
patient journey and clinical outcomes in the real world due to limited external validity or …

Real‐world data (RWD) and real‐world evidence (RWE) are increasingly used to support
regulatory decision making, but regulatory agencies and stakeholders may apply different …

Aim: To explore current uses of real-world evidence (RWE) in the US healthcare system,
summarize key concerns and highlight various opportunities that could be realized through …

Advances in the digitization of health systems and expedited regulatory approvals of
innovative treatments have led to increased potential for the use of real-world data (RWD) to …

Policy makers face challenges with the number of drugs for rare indications and rapidly
rising costs. In facing these challenges, decision-makers see real-world evidence (RWE) as …

In late 2018, the Food and Drug Administration (FDA) outlined a framework for evaluating
the possible use of real-world evidence (RWE) to support regulatory decision-making. This …