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UrduWhile 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, hosted on Open Science Framework (OSF), developed and maintained by Center for Open Science, 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.
“We are very excited to have launched the Real-World Evidence Registry,” stated ISPOR’s Chief Science Officer Richard J. Willke, PhD. “This Registry builds on the work of the Real-World Evidence Transparency Initiative and the recommendations from that group’s 2020 publication. We see the Registry as a significant step toward improving the transparency and credibility of RWE studies.”
“We partnered with the Open Science Foundation to create a simplified registry in an effort to promote a more widespread culture of registering RWD study protocols,” noted Shirley V. Wang, PhD, Harvard Medical School. “Registration with the RWE Registry provides a citable DOI that can be linked to the investigator’s ORCID ID and project wiki space to share study analysis code and other supporting materials. The new site is designed to encourage protocol registration for investigators and sponsors who do already have a mandate or workflow to register on another site (eg, clinicaltrials.gov or the EU post-authorization study registry).”
Additional information can be found on ISPOR’s real-world evidence strategic initiatives, the Real-World Evidence Transparency Initiative, the Real-World Evidence Registry via the links below:
- About the Real-World Evidence Registry
- Real-World Evidence Registry
- Real-World Evidence Transparency Initiative
- [Publication] “Improving Transparency to Build Trust in Real-World Secondary Data Studies for Hypothesis Testing—Why, What, and How: Recommendations and a Road Map from the Real-World Evidence Transparency Initiative”
- [Webinar] “Shaking the Myth of Real-World Evidence”
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ABOUT ISPOR
ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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