HARmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-world Evidence Studies on Treatment Effects (Japanese Version)： A Good Practices Report of a Joint ISPE/ISPOR Task Force

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  • FUKASAWA Toshiki
    Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan Department of Digital Health and Epidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan
  • IWAGAMI Masao
    Department of Health Services Research, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan London School of Hygiene and Tropical Medicine, University of London, London, UK
  • HARA Azusa
    Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University, Tokyo, Japan
  • NONAKA Takahiro
    Department of Health and Medical Innovation, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan
  • URUSHIHARA Hisashi
    Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University, Tokyo, Japan

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Other Title
  • 治療効果に関する仮説を評価するリアルワールドエビデンス研究の再現性向上に向けた調和プロトコルテンプレート（HARPER日本語版）：ISPE/ISPOR 合同タスクフォースの実施基準に関する報告（邦訳）
  • チリョウ コウカ ニ カンスル カセツ オ ヒョウカ スル リアルワールドエビデンス ケンキュウ ノ サイゲン セイコウ ジョウ ニ ムケタ チョウワ プロトコルテンプレート(HARPER ニホンゴバン) : ISPE/ISPOR ゴウドウ タスクフォース ノ ジッシ キジュン ニ カンスル ホウコク(ホウヤク)

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Abstract

<p>Problem： Ambiguity in communication of key study parameters limits the utility of real-world evidence （RWE） studies in healthcare decision-making. 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. </p><p>What We Did： The International Society for Pharmacoepidemiology (ISPE) and ISPOR―The Professional Society for Health Economics and Outcomes Research (ISPOR) convened a joint task force, including representation from key international stakeholders, to create a harmonized protocol template for RWE studies that evaluate a treatment effect and are intended to inform decision-making. The template builds on existing efforts to improve transparency and incorporates recent insights regarding the level of detail needed to enable RWE study reproducibility. The overarching principle was to reach for sufficient clarity regarding data, design, analysis, and implementation to achieve 3 main goals. One, to help investigators thoroughly consider then document their choices and rationale for key study parameters that define the causal question (e.g., target estimand), two, to facilitate decision-making by enabling reviewers to readily assess potential for biases related to these choices, and three, to facilitate reproducibility. </p><p>Strategies to Disseminate and Facilitate Use： Recognizing that the impact of this harmonized template relies on uptake, we have outlined a plan to introduce and pilot the template with key international stakeholders over the next 2 years. </p><p>Conclusion： The HARmonized Protocol Template to Enhance Reproducibility (HARPER) helps to create a shared understanding of intended scientific decisions through a common 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, through implementation and reporting on those implementation decisions</p>

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