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Evidence to Support Inclusion of Pharmacogenetic Biomarkers in Randomised Controlled Trials

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Institute of Translational Medicine, Department of Biostatistics, University of Liverpool, Waterhouse Building, 1-5 Brownlow Street, Liverpool L69 3GL, UK
2
Centre for Health Economics and Medicines Evaluation, Bangor University, Ardudwy, Normal Site, Bangor LL57 2PZ, UK
3
MRC Centre for Drug Safety Science and Wolfson Centre for Personalised Medicine, Institute of Translational Medicine, Waterhouse Building, 1-5 Brownlow Street, Liverpool L69 3GL, UK
*
Author to whom correspondence should be addressed.
J. Pers. Med. 2019, 9(3), 42; https://doi.org/10.3390/jpm9030042
Received: 30 July 2019 / Revised: 15 August 2019 / Accepted: 19 August 2019 / Published: 1 September 2019
Pharmacogenetics and biomarkers are becoming normalised as important technologies to improve drug efficacy rates, reduce the incidence of adverse drug reactions, and make informed choices for targeted therapies. However, their wider clinical implementation has been limited by a lack of robust evidence. Suitable evidence is required before a biomarker’s clinical use, and also before its use in a clinical trial. We have undertaken a review of five pharmacogenetic biomarker-guided randomised controlled trials (RCTs) and evaluated the evidence used by these trials to justify biomarker inclusion. We assessed and quantified the evidence cited in published rationale papers, or where these were not available, obtained protocols from trial authors. Very different levels of evidence were provided by the trials. We used these observations to write recommendations for future justifications of biomarker use in RCTs and encourage regulatory authorities to write clear guidelines. View Full-Text
Keywords: pharmacogenetics; biomarker; adverse drug reactions; RCT; evidence pharmacogenetics; biomarker; adverse drug reactions; RCT; evidence
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Johnson, D.; Hughes, D.; Pirmohamed, M.; Jorgensen, A. Evidence to Support Inclusion of Pharmacogenetic Biomarkers in Randomised Controlled Trials. J. Pers. Med. 2019, 9, 42.

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