The Real-World Evidence Transparency Initiative Partnership is a joint collaboration and ongoing effort between ISPOR, the International Society for Pharmacoepidemiology, the Duke-Margolis Center for Health Policy, and the National Pharmaceutical Council. The objective of this initiative is to establish a culture of transparency for study analysis and reporting of hypothesis evaluating real-world evidence studies on treatment effects.

Real-world evidence on treatment outcomes can be an important aspect of the evidence basis for decision making if it is seen as credible. For real-world studies that are meant to test hypotheses about comparative-effectiveness or safety, a key aspect of credibility is that they are conducted transparently with tests that follow a prespecified analytic protocol. Preregistration of such study protocols on a public website would help build trust that their results can be used for decision-making purposes.

Real-World Evidence Transparency Initiative White Paper

On September 18, the steering committee of the Real-World Evidence Transparency Initiative released a draft white paper for public comment. The white paper focuses on the need for study registration as a necessary first step towards improving transparency and trust in non-interventional research for hypothesis testing.

We invite public comment on the draft paper to help inform the final white paper. The draft paper and an online comment form can be accessed below.


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