Pharmacoepidemiol Risk Manage.
2024 Sep;16(2):100-112. 10.56142/perm.24.0010.
Translation of 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
- Affiliations
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- 1Department of Health Convergence, College of Science and Industry Convergence, Ewha Womans University, Seoul, Korea
- 2Graduate School of Industrial Pharmaceutical Science, College of Pharmacy, Ewha Womans University, Seoul, Korea
- 3Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, Korea
- 4Department of Digital Medicine, University of Ulsan College of Medicine, Seoul, Korea
- 5School of Pharmacy, Sungkyunkwan University, Suwon, Korea
- 6Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea
- 7Samsung Advanced Institute for Health Sciences and Technology, Sungkyunkwan University, Seoul, Korea
- 8Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea
- KMID: 2564475
- DOI: http://doi.org/10.56142/perm.24.0010
Abstract
- Reproducibility and transparency are fundamental scientific principles that enhance research efficiency, facilitate corrections, and strengthen the reliability of published literature. The clearer each stage of the research process is, the easier it is for reviewers to understand how evidence was obtained and to evaluate the validity of the methods used. This also helps in understanding differences between studies addressing similar topics. A recent evaluation has revealed significant discrepancies in the transparency of real-world evidence (RWE) studies, emphasizing the need for rigorous and internationally agreed-upon guidelines. To address this issue, the International Society for Pharmacoepidemiology (ISPE) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) have formed a joint task force with key stakeholders to develop a harmonized protocol template for RWE studies, aimed at assessing treatment effects and guiding decision-making. The HARmonized Protocol Template to Enhance Reproducibility (HARPER) incorporates various sections, guidelines, and structures from four protocol templates developed by multiple stakeholders and international organizations for RWE studies, which have been thoroughly evaluated, integrated, and updated. HARPER assists in building a common understanding of intended scientific decisions through a unified format of text, tables, and visuals. To assist Korean researchers in developing clearer and more reproducible research designs, we present the development process and usage guidelines of the HARPER format, along with the final version template, all translated into Korean from the original English publication.
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