ArticlePharmacogenetics and genomics2020
Generating evidence for precision medicine: considerations made by the Ubiquitous Pharmacogenomics Consortium when designing and operationalizing the PREPARE study.
Article in Pharmacogenetics and genomics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
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The trial behind it
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Who cites it
24 citing papers in PubMed, 40 citations in OpenAlex.
- Actionable Pharmacogenomics and Essential Medicines: An Analysis of WHO and African Lists for Safer and Efficacious Drug Use.Clinical pharmacology and therapeutics · 2026Review
- Pharmacogenomics in drug therapy: global regulatory guidelines for managing high-risk drug reactions.European journal of human genetics : EJHG · 2026Review
- Multinational cost-utility analysis of panel-based pharmacogenetics-guided treatment of patients enrolled in the U-PGx PREPARE study.EClinicalMedicine · 2026Article
- Model-based clinical utility of pharmacogenetic testing and its potential population impact on the use of essential medicines in Zimbabwe.Frontiers in pharmacology · 2026Article
- The Perceived Value of Pharmacogenetic Testing in Depression Treatment: Mixed-Methods Results From the PRIME Care Study.Psychiatric services (Washington, D.C.) · 2025Article
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- Pharmacogenomics and Big Data in medical oncology: developments and challenges.Therapeutic advances in medical oncology · 2024Review
- The influence of age, gender and pharmacogenetic profiles on the perspective on medicines in the German EMPAR study.PloS one · 2024Observational
- Analysis of the current situation of pharmacogenomics in terms of educational and healthcare needs in Egypt and Lebanon.Pharmacogenomics · 2024Article
- Pharmacogenomics: current status and future perspectives.Nature reviews. Genetics · 2023Review
- Metabolomics and NMR.Handbook of experimental pharmacology · 2023Article
- Targeted haplotyping in pharmacogenomics using Oxford Nanopore Technologies' adaptive sampling.Frontiers in pharmacology · 2023Article
- Allergic and other adverse reactions to drugs used in anesthesia and surgery.Anesthesiology and perioperative science · 2023Review
- External control arms: COVID-19 reveals the merits of using real world evidence in real-time for clinical and public health investigations.Frontiers in medicine · 2023Review
- Ten-year experience with pharmacogenetic testing forFrontiers in pharmacology · 2023Article
- Pharmacogenomics of Monoclonal Antibodies for the Treatment of Rheumatoid Arthritis.Journal of personalized medicine · 2022Review
- Drug-Drug-Gene Interactions in Cardiovascular Medicine.Pharmacogenomics and personalized medicine · 2022Review
- Multisite investigation of strategies for the clinical implementation of pre-emptive pharmacogenetic testing.Genetics in medicine : official journal of the American College of Medical Genetics · 2021Article
Corrections and comments
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Authors and funding
27 authors at 16 institutions in 11 countries.
Funding
Abstract
objectivesPharmacogenetic panel-based testing represents a new model for precision medicine. A sufficiently powered prospective study assessing the (cost-)effectiveness of a panel-based pharmacogenomics approach to guide pharmacotherapy is lacking. Therefore, the Ubiquitous Pharmacogenomics Consortium initiated the PREemptive Pharmacogenomic testing for prevention of Adverse drug Reactions (PREPARE) study. Here, we provide an overview of considerations made to mitigate multiple methodological challenges that emerged during the design.
methodsAn evaluation of considerations made when designing the PREPARE study across six domains: study aims and design, primary endpoint definition and collection of adverse drug events, inclusion and exclusion criteria, target population, pharmacogenomics intervention strategy, and statistical analyses.
resultsChallenges and respective solutions included: (1) defining and operationalizing a composite primary endpoint enabling measurement of the anticipated effect, by including only severe, causal, and drug genotype-associated adverse drug reactions; (2) avoiding overrepresentation of frequently prescribed drugs within the patient sample while maintaining external validity, by capping drugs of enrolment; (3) designing the pharmacogenomics intervention strategy to be applicable across ethnicities and healthcare settings; and (4) designing a statistical analysis plan to avoid dilution of effect by initially excluding patients without a gene-drug interaction in a gatekeeping analysis.
conclusionOur design considerations will enable quantification of the collective clinical utility of a panel of pharmacogenomics-markers within one trial as a proof-of-concept for pharmacogenomics-guided pharmacotherapy across multiple actionable gene-drug interactions. These considerations may prove useful to other investigators aiming to generate evidence for precision medicine.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.