Pharmacogenetic Implementation Studies—Lessons Learned From the PREPARE Study
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.
Authors
- Siv Jönsson (ORCID: https://orcid.org/0000-0001-8240-0865)
- Rudolf Koopmann (ORCID: https://orcid.org/0000-0002-7416-6340)
- Lisanne E. N. Manson (ORCID: https://orcid.org/0000-0002-7797-9478)
- Vera H.M. Deneer (ORCID: https://orcid.org/0000-0002-8564-4424)
- Μαρία Σκώκου (ORCID: https://orcid.org/0000-0002-8579-8933)
- H. Abdullah-Koolmees (ORCID: https://orcid.org/0000-0003-3789-2383)
- Victoria Rollinson (ORCID: https://orcid.org/0009-0005-2436-1139)
- Christina Mitropoulou (ORCID: https://orcid.org/0000-0002-9184-4668)
- George P. Patrinos (ORCID: https://orcid.org/0000-0002-0519-7776)
- Henk‐Jan Guchelaar (ORCID: https://orcid.org/0000-0002-7085-1383)
- Tanja Blagus (ORCID: https://orcid.org/0000-0002-2104-9060)
- Cathelijne H. van der Wouden (ORCID: https://orcid.org/0000-0002-7728-8802)
- Gere Sunder‐Plassmann (ORCID: https://orcid.org/0000-0002-9253-9921)
- Marjolein Kriek
- Kathrin Blagec (ORCID: https://orcid.org/0000-0001-6261-5260)
- Lidija Konta
- Matthias Schwab (ORCID: https://orcid.org/0000-0002-9984-075X)
- Rossana Roncato (ORCID: https://orcid.org/0000-0002-4219-6182)
- Jesse J. Swen (ORCID: https://orcid.org/0000-0002-3965-5552)
- Katja Susanne Just (ORCID: https://orcid.org/0000-0002-6782-8078)
- Elke Schaeffeler (ORCID: https://orcid.org/0009-0005-2997-0355)
- Erika Cecchin (ORCID: https://orcid.org/0000-0001-7517-7490)
- Giuseppe Toffoli (ORCID: https://orcid.org/0000-0002-5323-4762)
- Vita Dolžan (ORCID: https://orcid.org/0000-0001-6707-6649)
- Mats O. Karlsson (ORCID: https://orcid.org/0000-0003-1258-8297)
- Roman Tremmel (ORCID: https://orcid.org/0000-0003-1564-0433)
- Cristina Lucía Dávila-Fajardo (ORCID: https://orcid.org/0000-0003-3339-239X)
- Candace Joefield‐Roka
- Julia Stingl (ORCID: https://orcid.org/0000-0002-1566-8156)
- Thorsten Lehr (ORCID: https://orcid.org/0000-0002-8372-1465)
- Richard M. Turner (ORCID: https://orcid.org/0000-0002-7315-679X)
- Matthias Samwald (ORCID: https://orcid.org/0000-0002-4855-2571)
- Stefan Böhringer (ORCID: https://orcid.org/0000-0001-9108-9212)
- Mandy H. van Rhenen
- Daniela Steinberger (ORCID: https://orcid.org/0000-0002-1428-4062)
- Ka‐Chun Cheung
Institutions
- Uppsala University (SE)
- University of Liverpool (GB)
- University of Ljubljana (SI)
- Austrian Research Institute for Artificial Intelligence (AT)
- University of Patras (GR)
- Utrecht University (NL)
- United Arab Emirates University (AE)
- Leiden University Medical Center (NL)
- University Medical Center Utrecht (NL)
- Golden Helix Foundation (GB)
- Royal Dutch Pharmacists Association (NL)
- Instituto de Investigación Biosanitaria de Granada (ES)
- Hospital Universitario Virgen de las Nieves (ES)
- Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology (DE)
- Centro di Riferimento Oncologico (IT)
- Pfizer-University of Granada-Junta de Andalucía Centre for Genomics and Oncological Research (ES)
- Amsterdam University Medical Centers (NL)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
- Medical University of Vienna (AT)
- University of Tübingen (DE)
- RWTH Aachen University (DE)
- Zayed University (AE)
- Saarland University (DE)
Publication Details
- Journal
- Clinical Pharmacology & Therapeutics
- Published
- 2025-06-24
- DOI
- https://doi.org/10.1002/cpt.3749
- Citations
- 4
- Primary Topic
- Pharmacogenetics and Drug Metabolism
- Type
- article
- Field-Weighted Citation Impact
- 6.23
Funders
- European Commission