ISPOR’s Real-World Evidence Transparency Initiative: Creating a Road Map That Builds Trust

Lawrenceville, NJ, USA—October 5, 2020—ISPOR, the professional society for health economics and outcomes research, announced today the publication of a plan from the Real-World Evidence Transparency Initiative to encourage routine registration of noninterventional real-world evidence studies used to evaluate treatment effects. The report, “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,” was published in the September 2020 issue of Value in Health.

Real-world data and the derivations of these data into real-world evidence are rapidly expanding from informing healthcare decisions at the patient and health system level to influencing major health policy decisions, including regulatory approvals and coverage. A key to optimal uptake of real-world evidence is transparency of the research process. A joint task force of ISPOR and the International Society for Pharmacoepidemiology (ISPE) has previously recommended that investigators preregister their real-world evidence studies and post their study protocols in a publicly available forum, but study registration remains uncommon.

“Recognizing that published recommendations alone are insufficient unless they are implemented, ISPOR brought 30 experts together in 2019 to explore the structural and practical challenges to successful implementation of the ISPOR/ISPE task force’s recommendations,” said Lucinda S. Orsini, DPM, MPH, ISPOR, Lawrenceville, NJ, USA. “The meeting and the continued discussions led to the creation of the Real-World Evidence Transparency Initiative.” The Initiative’s goal was to reach consensus on considerations and recommendations that could help establish a culture of transparency for analysis and the reporting of hypothesis-evaluating real-world evidence studies. These studies will be the ones most likely to inform decision making and, therefore, are under the most scrutiny.

The plan includes specifying the rationale for registering hypothesis-evaluating treatment effectiveness real-world evidence studies, the studies that should be registered, where and when these studies should be registered, how and when analytic deviations from protocols should be reported, how and when to publish results, and incentives to encourage registration.

“The Real-World Evidence Transparency Initiative has identified short-, medium-, and long-term recommendations for building on the foundation of existing study registries, acknowledged issues that affect the practicality of the registration process, and considered how to facilitate routine registration of hypothesis-evaluating treatment effectiveness real-world evidence studies,” said Dr Orsini. “The recommendations address the unique characteristics of the studies that use secondary real-world data to generate hypothesis-evaluating real-world evidence on treatment effects. Improving the culture of transparency can help shed light on hypothesis-evaluating treatment effectiveness real-world evidence study practices so that users of the results can better determine study quality for themselves.”

Additional information on the Real-World Evidence Transparency initiative can be found here.



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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Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help healthcare leaders make evidence-based decisions. The journal’s 2019 impact factor score is 4.748. Value in Health is ranked 5th of 87 journals in health policy and services, 7th of 102 journals in healthcare sciences and services, and 19th of 371 journals in economics. Value in Health is a monthly publication that circulates to more than 10,000 readers around the world.
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