Pharmacogenetic Implementation Studies-Lessons Learned From the PREPARE Study
Publication date
2025-10
Authors
Ubiquitous Pharmacogenomics Consortium
Guchelaar, Henk-Jan
van der Wouden, Cathelijne H
Manson, Lisanne E N
Abdullah, Heshu
Blagec, Kathrin
Blagus, Tanja
Böhringer, Stefan
Cecchin, Erika
Cheung, Ka-Chun
Editors
Advisors
Supervisors
Document Type
Article
Metadata
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License
cc_by_nc_nd
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.
Keywords
Pharmacology, Pharmacology (medical)
Citation
Ubiquitous Pharmacogenomics Consortium, Guchelaar, H-J, van der Wouden, C H, Manson, L E N, Abdullah-Koolmees, H, Blagec, K, Blagus, T, Böhringer, S, Cecchin, E, Cheung, K-C, Deneer, V H M, Jonsson, S, Joefield-Roka, C, Just, K S, Karlsson, M O, Konta, L, Koopmann, R, Kriek, M, Lehr, T, Mitropoulou, C, Rollinson, V, Roncato, R, Samwald, M, Schaeffeler, E, Skokou, M, Schwab, M, Steinberger, D, Stingl, J C, Tremmel, R, Turner, R M, van Rhenen, M H, Dávila-Fajardo, C L, Dolžan, V, Patrinos, G P, Pirmohamed, M, Sunder-Plassmann, G, Toffoli, G & Swen, J J 2025, 'Pharmacogenetic Implementation Studies-Lessons Learned From the PREPARE Study', Clinical Pharmacology and Therapeutics, vol. 118, no. 4, pp. 803-812. https://doi.org/10.1002/cpt.3749