Pharmacogenetic Implementation Studies—Lessons Learned From the PREPARE Study

IF 5.5 2区医学 Q1 PHARMACOLOGY & PHARMACY

Clinical Pharmacology & Therapeutics Pub Date : 2025-06-24 DOI:10.1002/cpt.3749

Henk-Jan Guchelaar, Cathelijne H. van der Wouden, Lisanne E. N. Manson, Heshu Abdullah-Koolmees, Kathrin Blagec, Tanja Blagus, Stefan Böhringer, Erika Cecchin, Ka-Chun Cheung, Vera H. M. Deneer, Siv Jonsson, Candace Joefield-Roka, Katja S. Just, Mats O. Karlsson, Lidija Konta, Rudolf Koopmann, Marjolein Kriek, Thorsten Lehr, Christina Mitropoulou, Victoria Rollinson, Rossana Roncato, Matthias Samwald, Elke Schaeffeler, Maria Skokou, Matthias Schwab, Daniela Steinberger, Julia C. Stingl, Roman Tremmel, Richard M. Turner, Mandy H. van Rhenen, Cristina L. Dávila-Fajardo, Vita Dolžan, George P. Patrinos, Munir Pirmohamed, Gere Sunder-Plassmann, Giuseppe Toffoli, Jesse J. Swen, Ubiquitous Pharmacogenomics Consortium

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Abstract

The Ubiquitous Pharmacogenomics consortium (www.upgx.eu) has recently completed and published the Preemptive Pharmacogenomic Testing for Preventing Adverse Drug Reactions (PREPARE) study on the implementation of panel-based pharmacogenetic testing. PREPARE has provided interesting lessons for the design, execution, and interpretation of future clinical implementation studies. In this paper, we share our experience and lessons learned from the PREPARE study for future pharmacogenetic implementation studies. Issues addressed are the study population, intervention, endpoint, randomization, blinding, crossover, ethics, real-world changes during the study, and data analysis and reporting.

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药物遗传学实施研究——从PREPARE研究中获得的经验教训。

无所不在的药物基因组学联盟（www.upgx.eu）最近完成并发表了预防药物不良反应的预防性药物基因组学测试（PREPARE）研究，该研究的实施是基于小组的药物遗传学测试。PREPARE为未来临床实施研究的设计、执行和解释提供了有趣的经验教训。在本文中，我们分享了从PREPARE研究中获得的经验和教训，以供未来的药物遗传实施研究。涉及的问题包括研究人群、干预措施、终点、随机化、盲法、交叉、伦理、研究期间的现实世界变化以及数据分析和报告。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Pharmacology & Therapeutics 医学-药学

CiteScore

12.70

自引率

7.50%

发文量

290

审稿时长

2 months

期刊介绍： Clinical Pharmacology & Therapeutics (CPT) is the authoritative cross-disciplinary journal in experimental and clinical medicine devoted to publishing advances in the nature, action, efficacy, and evaluation of therapeutics. CPT welcomes original Articles in the emerging areas of translational, predictive and personalized medicine; new therapeutic modalities including gene and cell therapies; pharmacogenomics, proteomics and metabolomics; bioinformation and applied systems biology complementing areas of pharmacokinetics and pharmacodynamics, human investigation and clinical trials, pharmacovigilence, pharmacoepidemiology, pharmacometrics, and population pharmacology.