Expert insight:

What you should know about RWE:

By Dr. Paul Craddy & Dr. Graham Foxon, expert-trainers of the Generating RWE for Optimising Market Access course.

Real-world evidence (RWE) refers to clinical and economic evidence which has been derived from the analysis of real-world data (RWD). Although often used interchangeably, it is important to understand that both RWE and RWD are distinct.

RWD refers to data relating to patient health status and/or the delivery of health care collected from a variety of real-world sources. These sources can include (but are not limited to): electronic health records, patient registries, patient-generated health data, observational trials and pragmatic trials. It is through the analysis and interpretation of RWD that RWE is generated.

Unlike traditional randomised controlled trials (RCTs), generation of RWE allows researchers significantly less involvement and control of medical management of the patient beyond observing outcomes. The limited control of researchers can result in evidence which is more representative of clinical practice than that generated from RCTs. This can often allow results to be more generalisable to a wider population of patients and can play an important role both pre- and post-product launch, aiding in regulatory approval, patient access and physician awareness.

However, it is important to note that RWE is not without weaknesses. The lack of control in collecting RWD and generating RWE can increase the risk of both bias and confounding factors. In addition, quality, accessibility, transparency and extensiveness of coverage of RWD can vary significantly, requiring caution when choosing the most relevant source.

Stereotypically, RWE is often seen as a quick, easy and cheap method to generate evidence. In practice, the complexity of RWE generation will depend on which of the many methods are utilised. For instance, generation of RWE through a survey will be significantly easier than that of setting up a new patient registry.

Overall, RWE has the ability to play an important role in demonstrating value and meeting the needs of various stakeholders throughout a products life cycle (both pre- and post-launch). The strengths, weaknesses, time and resource intensity of RWE generation will ultimately depend on the approach taken. To be most supportive of a value proposition, it is important that RWE is implemented strategically and systematically within the overall evidence base.

Last update: December 2021


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