The Real-World Evidence Registry provides researchers with a fit-for-purpose platform to register their study designs before they begin work to facilitate the transparency needed to elevate the trust in the study results. The Registry was developed as part of the Real-World Evidence Transparency Initiative—a partnership between ISPOR, the International Society for Pharmacoepidemiology (ISPE), the Duke-Margolis Center for Health Policy, and the National Pharmaceutical Council (NPC).
Real-world evidence studies can be used for hypothesis evaluation of treatment effects including safety (HETE studies). However these studies can also be perceived as less rigorous than clinical trials especially when not preregistered in a public setting such as ClinicalTrials.gov or the EU-PAS register.
ISPOR and its partners ISPE, NPC, and Duke Margolis have developed a simplified registration site especially for RWE HETE studies using secondary data. This searchable site provides a place for preregistration of studies that may not require registration for regulatory purposes but benefit from the rigor of transparent study methods and also provide a reference (such as a URL or doi) to share with peer reviewers, assessors, or other decision making bodies. Researchers can get started ‘here’ by creating a profile on the Open Sciences Framework and registering their study on the RWE Registry.
What Is the Real-World Evidence Registry?
ISPOR Chief Science Officer, Richard J. Willke, PhD and Shirley Wang, PhD of Harvard Medical School provide an overview of the Real-World Evidence Registry for researchers and other healthcare stakeholders who have an interest in RWE.
How to Submit Research to the Real-World Evidence Registry
Luke Zabotka, research assistant at Brigham and Women's Hospital and Harvard Medical School in the Division of Pharmacoepidemiology and Pharmacoeconomics, demonstrates how to submit a study protocol to the RWE Registry.
- Real-World Evidence Transparency Initiative
- Good Practices Reports and Other ISPOR Reports from Value in Health
- "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"
- "Good Practices for Real-World Data Studies of Treatment and/or Comparative Effectiveness"
- "Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0"
- ISPOR Good Practices Reports for Real-World Data
- All ISPOR Good Practices Reports and Other ISPOR Reports
- "Unlocking the Promise of Real-World Evidence" (Value & Outcomes Spotlight, Vol. 6, No. 5)
- ISPOR's Real-World Evidence Strategic Initiatives
Shaking the Myth of Real-World Evidence
Learn more by watching the on-demand webinar, “Shaking the Myth of Real-World Evidence: Updates from the RWE Transparency Initiative.” This session provides updates from the initiative including a walk-through of the study registration site and updates on the special task force developing a standardized RWE protocol template.