Pharmacogenetic Implementation Studies-Lessons Learned From the PREPARE Study

Ubiquitous Pharmacogenomics Consortium; 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

doi:10.1002/cpt.3749

Pharmacogenetic Implementation Studies-Lessons Learned From the PREPARE Study

Ubiquitous Pharmacogenomics Consortium, 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 MitropoulouVictoria 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

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Number of pages	10
Journal	Clinical Pharmacology and Therapeutics
DOIs	https://doi.org/10.1002/cpt.3749
Publication status	E-pub ahead of print - 24 Jun 2025

Bibliographical note

Funding

The PREPARE study was funded by the European Union, Horizon 2020 Research and Innovation Program under grant agreement no. 668353.

Funders	Funder number
European Union, Horizon 2020 Research and Innovation Program	668353

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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., ... Swen, J. J. (2025). Pharmacogenetic Implementation Studies-Lessons Learned From the PREPARE Study. Clinical Pharmacology and Therapeutics. Advance online publication. https://doi.org/10.1002/cpt.3749

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title = "Pharmacogenetic Implementation Studies-Lessons Learned From the PREPARE Study",

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.",

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

note = "{\textcopyright} 2025 The Author(s). Clinical Pharmacology \& Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.",

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doi = "10.1002/cpt.3749",

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Ubiquitous Pharmacogenomics Consortium, Guchelaar, H-J, van der Wouden, CH, Manson, LEN, Abdullah-Koolmees, H, Blagec, K, Blagus, T, Böhringer, S, Cecchin, E, Cheung, K-C, Deneer, VHM, Jonsson, S, Joefield-Roka, C, Just, KS, Karlsson, MO, 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, JC, Tremmel, R, Turner, RM, van Rhenen, MH, Dávila-Fajardo, CL, Dolžan, V, Patrinos, GP, Pirmohamed, M, Sunder-Plassmann, G, Toffoli, G & Swen, JJ 2025, 'Pharmacogenetic Implementation Studies-Lessons Learned From the PREPARE Study', Clinical Pharmacology and Therapeutics. https://doi.org/10.1002/cpt.3749

TY - JOUR

T1 - Pharmacogenetic Implementation Studies-Lessons Learned From the PREPARE Study

AU - Ubiquitous Pharmacogenomics Consortium

AU - Guchelaar, Henk-Jan

AU - van der Wouden, Cathelijne H

AU - Manson, Lisanne E N

AU - Abdullah-Koolmees, Heshu

AU - Blagec, Kathrin

AU - Blagus, Tanja

AU - Böhringer, Stefan

AU - Cecchin, Erika

AU - Cheung, Ka-Chun

AU - Deneer, Vera H M

AU - Jonsson, Siv

AU - Joefield-Roka, Candace

AU - Just, Katja S

AU - Karlsson, Mats O

AU - Konta, Lidija

AU - Koopmann, Rudolf

AU - Kriek, Marjolein

AU - Lehr, Thorsten

AU - Mitropoulou, Christina

AU - Rollinson, Victoria

AU - Roncato, Rossana

AU - Samwald, Matthias

AU - Schaeffeler, Elke

AU - Skokou, Maria

AU - Schwab, Matthias

AU - Steinberger, Daniela

AU - Stingl, Julia C

AU - Tremmel, Roman

AU - Turner, Richard M

AU - van Rhenen, Mandy H

AU - Dávila-Fajardo, Cristina L

AU - Dolžan, Vita

AU - Patrinos, George P

AU - Pirmohamed, Munir

AU - Sunder-Plassmann, Gere

AU - Toffoli, Giuseppe

AU - Swen, Jesse J

PY - 2025/6/24

Y1 - 2025/6/24

N2 - 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.

AB - 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.

U2 - 10.1002/cpt.3749

DO - 10.1002/cpt.3749

M3 - Article

C2 - 40552566

SN - 0009-9236

JO - Clinical Pharmacology and Therapeutics

JF - Clinical Pharmacology and Therapeutics

ER -

Pharmacogenetic Implementation Studies-Lessons Learned From the PREPARE Study

Abstract

Bibliographical note

Funding

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