Global Expert Panel Publishes New Guidance on Designing and Conducting Real-World Evidence Studies

Published Oct 11, 2022

A Good Practices Report of the Joint ISPE/ISPOR Task Force

Lawrenceville, NJ, USA—October 11, 2022—Value in Health, the official journal of ISPOR—The Professional Society for Health Economics and Outcomes Research, announced today the publication of a new template that provides a set of core recommendations for clear and reproducible real-world evidence study protocols and is intended to be used throughout the research process. The report, “Harmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects: A Good Practices Report of a Joint ISPE/ISPOR Task Force,” was published in the October 2022 issue of Value in Health.

“Ambiguity in the communication of key study parameters limits the utility of real-world evidence (RWE) studies in healthcare decision making,” said lead author Shirley V. Wang PhD, Brigham and Women's Hospital, Harvard Medical School. “Clear communication about data provenance, design, analysis, and implementation is needed. This would facilitate reproducibility, replication in independent data, and assessment of potential sources of bias.”

In response to this need, the International Society for Pharmacoepidemiology (ISPE) and ISPOR convened a joint task force to create a harmonized protocol template for RWE studies. The template builds on existing efforts to improve transparency and incorporates recent insights regarding the level of detail needed to enable study reproducibility.

“The overarching principle of this effort was to reach for sufficient clarity to achieve 3 main goals,” noted Wang. “First, help investigators thoroughly consider and document their choices and rationale for key study parameters that define the causal question. Second, facilitate decision making by enabling reviewers to readily assess potential for biases related to these choices. And third, facilitate reproducibility.”

The output of the joint ISPE/ISPOR task force effort, the HARmonized Protocol Template to Enhance Reproducibility (HARPER), helps create a shared understanding of intended scientific decisions through a text, tabular, and visual structure. The template provides a set of core recommendations for clear and reproducible RWE study protocols and is intended to be used as a backbone throughout the research process from developing a valid study protocol, to registration, and through implementation and reporting on those implementation decisions.

Once published, HARPER will be freely available for anyone to download and use. However, recognizing that the impact of HARPER relies on uptake, the joint task force has outlined a strategy to introduce and pilot the template with numerous key stakeholders over the next 2 years. They will be presenting the template directly to international regulatory agencies and health technology assessment groups and are laying the groundwork to pilot test the template with ongoing demonstration projects that are evaluating or guiding the use of RWE to support decision making.

“HARPER has been designed to reduce ambiguity by helping research teams be clear about the scientific decisions made in the design and conduct of an RWE study and to allow other investigators or reviewers to have a shared understanding of those decisions,” said Wang. “Going forward, we recognize that real-world data analytics is a rapidly evolving field and that this work may need iterative revision. Therefore, we plan to have the harmonized template reviewed and updated as needed through a standing review process.”

Background on the ISPE-ISPOR Joint Task Force

ISPOR is actively working to improve standards and practice for the collection and analysis of real-world data. The Society views this initiative as a critical aspect of ISPOR’s mission to promote health economics and outcomes research excellence to improve decision making for health globally. As part of this effort, ISPOR partnered with ISPE to form the joint task force on Real-World Evidence in Healthcare Decision Making. In addition to this current report, the joint task force has produced and published 2 reports and an editorial in this area. To learn more about the task force and its publications, visit their webpage.

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ABOUT ISPOR
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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ABOUT VALUE IN HEALTH
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 2021 impact factor score is 5.101 and its 5-year impact factor score is 6.747. 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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ABOUT ISPOR GOOD PRACTICES REPORTS
ISPOR has earned an international reputation for research excellence based, in part, on its Good Practices Reports. These highly cited reports are expert consensus recommendations on good practice standards for outcomes research (clinical, economic, and patient-reported outcomes) and on the use of this research in healthcare decision making. ISPOR Task Forces comprise subject matter experts representing different stakeholders from diverse work environments (ie, regulators, payers, manufacturers, technology assessors, etc from research, government, academic, and industry sectors around the world). All ISPOR Good Practices Reports are published in the Society’s scientific journal, Value in Health, and are made freely available as part of the Society’s mission. The Society’s Good Practices Reports have been recognized with an ASAE “Power of A” award that acknowledges innovative, effective, and broad-reaching programs that have a positive impact on the world.

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