New Review on Inclusion of RWE in Regulatory Decisions

A new paper discusses the state of RWE (real world evidence) and RWD (real world data) in the context of pharmacoepidemiology. Important conclusions can be drawn from EHRs (electronic health records) and healthcare claims, among other sources. These types of data are being increasingly used in the context of regulatory applications and approvals. The timely review discusses what the future of drug development may bring.

The authors note,“[S]everal emerging trends over the past decade are converging to support the use of these and other RWD sources for approval decisions, and there are several recent examples and ongoing research that demonstrate how RWE may be used to support regulatory approval of new or expanded indications. The goal of this article is to review the current landscape and future directions of the use of RWE in this context.” Read more here.

(Source: Franklin et al., Pharmacoepidemiology & Drug Safety, 3/6/21)