Building Trust in Real-World Evidence: The Role of Study Registration

Published Nov 5, 2019

The Real-World Evidence Transparency Initiative

Real-World Evidence Transparency Initiative
Copenhagen, Denmark—5 November 2019—ISPOR, the professional society for health economics and outcomes research—examined real-world evidence studies and the importance of transparency in a number of sessions at ISPOR Europe 2019 in Copenhagen, Denmark.

Real-world evidence (RWE) on treatment outcomes can be an important aspect of healthcare decision making when it is seen as credible. Transparency of RWE studies is a critical aspect of building trust and credibility. The Real-World Evidence Transparency Initiative is being led through a partnership with ISPOR, the International Society for Pharmacoepidemiology (ISPE), the Duke Margolis Center for Health Policy, the National Pharmaceutical Council (NPC), and a number of other organizations and stakeholders. The objective of this initiative is to establish a culture of transparency for study analysis and the reporting of hypotheses evaluating real-world evidence studies on treatment effects. Several sessions focused on the work of the Initiative.

RWE offers many benefits that can be applied to healthcare decision making, such as the availability of timely data at reasonable cost, large sample sizes that enable analysis of subpopulations and less common effects, and the representativeness of real-world practice and behaviors. While RWE has tremendous potential, it also presents very real concerns that continue to cast shadows on its credibility, including the risk of bias, data quality (such as incomplete data), and the potential for p-hacking due to data mining.

Preregistration of RWE study protocols is an approach that can foster transparency and help build trust that RWE results can be used for decision-making purposes. The sessions centered on the Initiative highlighted the key elements needed for the creation of a common registration site for these real-world studies that will be oriented to regular use by researchers and seen as a credible registry by decision makers. Work that has already been completed in this effort was also presented. A draft white paper is currently available and open for review—“Improving Transparency in Non-Interventional Research for Hypothesis Testing—Why, What, and How: Considerations from The Real-World Evidence Transparency Initiative.” Additionally, the Initiative recently held a summit, “ISPOR Summit 2019: Real-World Evidence Transparency Initiative,” in Baltimore, MD, USA.

“Better study credibility is crucial for effective use of RWE for decision-making and greater transparency of process will help achieve that credibility,” stated ISPOR’s Chief Science Officer, Richard J. Willke, PhD. “This Initiative, a collaboration among key stakeholders in our field, aims to improve transparency not only through easing the logistics of study preregistration but also by establishing a culture of trust and transparency in the conduct of these studies.”

Additional information on the Real-World Evidence Transparency Initiative and the draft white paper can be found here.

ISPOR is recognized globally as the leading professional society for health economics and outcomes research and its role in improving healthcare decisions. ISPOR Europe 2019 expects to draw more than 5000 healthcare stakeholders with an interest in HEOR, including researchers and academicians, assessors and regulators, payers and policymakers, the life sciences industry, healthcare providers, and patient engagement organizations.

Additional information on the conference can be found at:
Conference Information | Program and Presentations | #ISPOREurope | Sponsors | Exhibitors | News and Press


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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