ISPOR—The Professional Society for Health Economics and Outcomes Research announced this week that the Real-World Evidence Transparency Initiative has launched the Real-World Evidence Registry. The initiative is a partnership between ISPOR, the International Society for Pharmacoepidemiology, the Duke-Margolis Center for Health Policy, and the National Pharmaceutical Council.
While randomized controlled trials (RCTs) remain the gold standard for conducting interventional research, much attention has focused on real-world evidence (RWE) studies that complement RCTs to evaluate treatment effectiveness. Thus, the volume of and interest in real-world data (RWD), or nonclinical trial data of clinical utility, that are used to generate and inform RWE studies have been growing exponentially.
The advantages of RWE studies include the availability of timely data at a reasonable cost, large sample sizes that enable the analysis of subpopulations not well represented in RCTs and the identification of less common effects, and the ability to better represent what treatment effects can be expected in real-world practice. While RWE offers tremendous potential, concerns exist about its credibility, such as biases that can result due to lack of randomization, lack of uniform data quality, and the potential for “data mining” where analyses are conducted until the desired result is found.
The objective of the Real-World Evidence Transparency Initiative is to address potential concerns with RWE studies by establishing a culture of transparency for the analysis and reporting of RWE in healthcare and health research. A key element to establishing credibility of and trust in RWE studies is transparency. The new Real-World Evidence Registry provides researchers with a platform to register their study protocols before they begin work. Using open, centralized workflows enhances collaboration and facilitates the transparency needed to elevate the trust in the study results.
The new site is designed to encourage protocol registration for investigators and sponsors who already have a mandate or workflow to register on another site (e.g., ClinicalTrials.gov or the European Union’s post-authorization study registry).
Edited by Gary Cramer