Real-World Data = Real-World Evidence
RWD resources, as exemplified by patient registries, clinical reports, insurance records et al, can be mined to inform on patient needs and validate research hypotheses. Validation can determine the design of clinical trial protocols focusing on the most critical anticipated outcomes. Additionally, it expedites the identification and recruitment of the appropriate patient sample most likely to benefit from the study attenuating the need for further post-approval patient monitoring panels.
...reduces the exclusive dependence upon
RCT for regulatory approval and subsequent extensive post-approval studies expediting market entry.
Key to the successful exploitation of RWE is its integration with RCT embedded as an integral component of the product R&D cycle. Adopting this homogenous approach reduces the exclusive dependence upon RCT for regulatory approval and subsequent extensive post-approval studies expediting market entry.
RWE has the latency to reveal treatment options potentially capable of addressing additional indications prompting the efficient expansion of clinical trials consonant with the economic criteria of commissioning bodies. The identification of and evidential support for, additional dispositions beyond label-defined ones as determined by RCT data, can expedite applications for an expanded licence with a concomitant reduction in the need for and cost of, post-market studies.