Pharmacogenetic Implementation Studies—Lessons Learned From the PREPARE Study

Clinical Pharmacology & Therapeutics, vol. 118, pp. 803–812

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.

Authors 36

1. Henk‐Jan Guchelaar corresponding Aachen Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden The Netherlands

   Leiden University Medical Center

   Affiliation as printed

   Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden The Netherlands

2. Cathelijne H. van der Wouden Aachen Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden The Netherlands

   Leiden University Medical Center

   Affiliation as printed

   Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden The Netherlands

3. Lisanne E. N. Manson Aachen Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden The Netherlands

   Leiden University Medical Center

   Affiliation as printed

   Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden The Netherlands

4. H. Abdullah-Koolmees

   Amsterdam University Medical Centers

   Affiliation as printed

   Department of Hospital Pharmacy Amsterdam University Medical Center Amsterdam The Netherlands

5. Kathrin Blagec

   Medical University of Vienna

   Affiliation as printed

   Institute of Artificial Intelligence, Centre for Medical Statistics, Informatics and Intelligent Systems Medical University of Vienna Vienna Austria

6. Tanja Blagus

   University of Ljubljana

   Affiliation as printed

   Pharmacogenetics Laboratory, Institute of Biochemistry and Molecular Genetics, Faculty of Medicine University of Ljubljana Ljubljana Slovenia

7. Stefan Böhringer Aachen Department of Biomedical Data Sciences Leiden University Medical Center Leiden The Netherlands Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden The Netherlands

   Leiden University Medical Center

   Affiliation as printed

   Department of Biomedical Data Sciences Leiden University Medical Center Leiden The Netherlands

   Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden The Netherlands

8. Erika Cecchin

   Centro di Riferimento Oncologico

   Affiliation as printed

   Experimental and Clinical Pharmacology Unit Centro di Riferimento Oncologico di Aviano (CRO) IRCCS Aviano Italy

9. Ka‐Chun Cheung

   Royal Dutch Pharmacists Association

   Affiliation as printed

   Medicines Information Centre, Royal Dutch Pharmacists Association (KNMP) The Hague The Netherlands

10. Vera H.M. Deneer

    Utrecht University · University Medical Center Utrecht

    Affiliation as printed

    Division Laboratories, Pharmacy and Biomedical Genetics Hospital Pharmacy, University Medical Center Utrecht The Netherlands

    Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University Utrecht The Netherlands

11. Siv Jönsson

    Uppsala University

    Affiliation as printed

    Department of Pharmacy Uppsala University Uppsala Sweden

12. Candace Joefield‐Roka

    Medical University of Vienna

    Affiliation as printed

    Division of Nephrology and Dialysis, Department of Medicine III Medical University of Vienna Vienna Austria

13. Katja Susanne Just Aachen Institute of Clinical Pharmacology

    Universitätsklinikum Aachen · RWTH Aachen University

    Affiliation as printed

    Institute of Clinical Pharmacology University Hospital RWTH Aachen Aachen Germany

14. Mats O. Karlsson

    Uppsala University

    Affiliation as printed

    Department of Pharmacy Uppsala University Uppsala Sweden

15. Lidija Konta
    Affiliation as printed

    Bio.logis Digital Health Frankfurt am Main Germany

16. Rudolf Koopmann
    Affiliation as printed

    Bio.logis Digital Health Frankfurt am Main Germany

17. Marjolein Kriek Aachen Department of Clinical Genetics Leiden University Medical Center Leiden The Netherlands

    Leiden University Medical Center

    Affiliation as printed

    Department of Clinical Genetics Leiden University Medical Center Leiden The Netherlands

18. Thorsten Lehr

    Saarland University

    Affiliation as printed

    Clinical Pharmacy Saarland University Saarbrücken Germany

19. Christina Mitropoulou

    United Arab Emirates University · Golden Helix Foundation

    Affiliation as printed

    Department of Genetics and Genomics College of Medicine and Health Sciences, United Arab Emirates University, Al‐Ain Abu Dhabi UAE

    The Golden Helix Foundation London UK

20. Victoria Rollinson

    University of Liverpool

    Affiliation as printed

    Department of Pharmacology and Therapeutics, Wolfson Centre for Personalised Medicine The University of Liverpool Liverpool UK

21. Rossana Roncato

    Centro di Riferimento Oncologico

    Affiliation as printed

    Experimental and Clinical Pharmacology Unit Centro di Riferimento Oncologico di Aviano (CRO) IRCCS Aviano Italy

22. Matthias Samwald

    Medical University of Vienna

    Affiliation as printed

    Institute of Artificial Intelligence, Centre for Medical Statistics, Informatics and Intelligent Systems Medical University of Vienna Vienna Austria

23. Elke Schaeffeler

    Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology · University of Tübingen

    Affiliation as printed

    Dr Margarete Fischer‐Bosch Institute of Clinical Pharmacology University of Tuebingen Stuttgart Germany

    iFIT Cluster of Excellence (EXC2180)‐Image Guided and Functionally Instructed Tumour Therapies University of Tuebingen Tuebingen Germany

24. Μαρία Σκώκου

    University of Patras

    Affiliation as printed

    Laboratory of Pharmacogenomics and Individualised Therapy, Division of Pharmacology and Biosciences, Department of Pharmacy University of Patras School of Health Sciences Patras Greece

25. Matthias Georg Schwab

    Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology · University of Tübingen

    Affiliation as printed

    Department of Clinical Pharmacology University of Tuebingen Tuebingen Germany

    Department of Pharmacy and Biochemistry University of Tuebingen Tuebingen Germany

    Dr Margarete Fischer‐Bosch Institute of Clinical Pharmacology University of Tuebingen Stuttgart Germany

    iFIT Cluster of Excellence (EXC2180)‐Image Guided and Functionally Instructed Tumour Therapies University of Tuebingen Tuebingen Germany

26. Daniela Steinberger
    Affiliation as printed

    Bio.logis Digital Health Frankfurt am Main Germany

27. Julia Stingl Aachen Institute of Clinical Pharmacology

    Universitätsklinikum Aachen · RWTH Aachen University

    Affiliation as printed

    Institute of Clinical Pharmacology University Hospital RWTH Aachen Aachen Germany

28. Roman Tremmel

    Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology · University of Tübingen

    Affiliation as printed

    Department of Clinical Pharmacology University of Tuebingen Tuebingen Germany

    Department of Pharmacy and Biochemistry University of Tuebingen Tuebingen Germany

    Dr Margarete Fischer‐Bosch Institute of Clinical Pharmacology University of Tuebingen Stuttgart Germany

    iFIT Cluster of Excellence (EXC2180)‐Image Guided and Functionally Instructed Tumour Therapies University of Tuebingen Tuebingen Germany

29. Richard Myles Turner

    University of Liverpool

    Affiliation as printed

    Department of Pharmacology and Therapeutics, Wolfson Centre for Personalised Medicine The University of Liverpool Liverpool UK

    GSK, Stevenage Hertfordshire UK

30. Mandy H. van Rhenen Aachen Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden The Netherlands

    Leiden University Medical Center

    Affiliation as printed

    Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden The Netherlands

31. Cristina Lucía Dávila-Fajardo

    Instituto de Investigación Biosanitaria de Granada · Hospital Universitario Virgen de las Nieves · Pfizer-University of Granada-Junta de Andalucía Centre for Genomics and Oncological Research

    Affiliation as printed

    Centro Pfizer‐Universidad de Granada‐Junta de Andalucía de Genómica e Investigación Oncológica (GENYO) Granada Spain

    Clinical Pharmacy Department Hospital Universitario Virgen de las Nieves, Instituto de Investigación Biosanitaria Granada Granada Spain

32. Vita Dolžan

    University of Ljubljana

    Affiliation as printed

    Pharmacogenetics Laboratory, Institute of Biochemistry and Molecular Genetics, Faculty of Medicine University of Ljubljana Ljubljana Slovenia

33. George P. Patrinos

    University of Patras · United Arab Emirates University · Erasmus MC · Erasmus University Rotterdam

    Affiliation as printed

    Clinical Bioinformatics Unit, Department of Pathology Faculty of Medicine and Health Sciences, Erasmus University Medical Centre Rotterdam The Netherlands

    Department of Genetics and Genomics College of Medicine and Health Sciences, United Arab Emirates University, Al‐Ain Abu Dhabi UAE

    Laboratory of Pharmacogenomics and Individualised Therapy, Division of Pharmacology and Biosciences, Department of Pharmacy University of Patras School of Health Sciences Patras Greece

    Zayed Centre for Health Sciences, College of Medicine and Health Sciences United Arab Emirates University Abu Dhabi UAE

34. Gere Sunder–Plassmann

    Medical University of Vienna

    Affiliation as printed

    Division of Nephrology and Dialysis, Department of Medicine III Medical University of Vienna Vienna Austria

35. Giuseppe Toffoli

    Centro di Riferimento Oncologico

    Affiliation as printed

    Experimental and Clinical Pharmacology Unit Centro di Riferimento Oncologico di Aviano (CRO) IRCCS Aviano Italy

36. Jesse Joachim Swen Aachen Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden The Netherlands

    Leiden University Medical Center

    Affiliation as printed

    Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden The Netherlands