Evidence to Support Inclusion of Pharmacogenetic Biomarkers in Randomised Controlled Trials

Johnson, Danielle ORCID: 0000-0001-7820-1687, Hughes, Dyfrig ORCID: 0000-0001-8247-7459, Pirmohamed, Munir ORCID: 0000-0002-7534-7266 and Jorgensen, Andrea ORCID: 0000-0002-6977-9337
(2019) Evidence to Support Inclusion of Pharmacogenetic Biomarkers in Randomised Controlled Trials. JOURNAL OF PERSONALIZED MEDICINE, 9 (3). E42-.

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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.

Item Type: Article
Uncontrolled Keywords: pharmacogenetics, biomarker, adverse drug reactions, RCT, evidence
Depositing User: Symplectic Admin
Date Deposited: 21 Aug 2019 08:22
Last Modified: 19 Jan 2023 00:28
DOI: 10.3390/jpm9030042
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3052212