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.
Events Held at ISPOR Europe 2019
A number of events on the RWE Transparency Initiative were held at ISPOR Europe 2019 on 2-6 November in Copenhagen, Denmark.
"Transparency in RWE - Time for a Unified Approach"
Spotlight Session: Monday, 4 November 2019, 14:15 - 15:15
"Transparency in RWE - Can We Navigate The Key Challenges?"
Issue Panel: Tuesday, 5 November 2019, 11:00 - 12:00
"Transparency in RWE – Moving Forward"
ISPOR Forum: Tuesday, 5 November 2019, 12:30 - 13:45
A news release on these sessions can be found here:
Look for information on the Initiative from Virtual ISPOR 2020 to come in the near future.
Real-World Evidence Transparency Initiative White Paper
On September 18, 2019, 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.
Following comments from membership and other stakeholders, the white paper was finalized and is pending publication in Value in Health as well as Pharmacoepidemiology and Drug Safety. Publication is expected in the third quarter of 2020.