Ex) Article Title, Author, Keywords
Ex) Article Title, Author, Keywords
Pharmacoepidemiology and Risk Management 2024; 16(2): 100-112
Published online September 30, 2024 https://doi.org/10.56142/perm.24.0010
Copyright © Korean Society for Pharmacoepidemiology and Risk Management.
Suvin Park1, Hee-Jin Kim1, Haerin Cho1, Jeong Ah Kim1, Hui-Eon Lee2, Heehyun Won1, Ye-Jee Kim3,4, Ju-Young Shin5,6,7, Joongyub Lee8, Nam-Kyong Choi1,2
박수빈1, 김희진1, 조해린1, 김정아1, 이희언2, 원희현1, 김예지3,4, 신주영5,6,7, 이중엽8, 최남경1,2
Correspondence to:Nam-Kyong Choi
Department of Health Convergence, Ewha Womans University, 52 Ewhayeodae-gil, Seodaemun-gu, Seoul 03760, Korea
Tel: +82-2-3277-6585
Fax: +82-2-3277-2867
E-mail: nchoi@ewha.ac.kr
This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
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.
KeywordsProtocol, Real world evidence, Reproducibility, Transparency
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