Evidence to support inclusion of pharmacogenetic biomarkers in randomised controlled trials

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Dangosydd eitem ddigidol (DOI)

  • Danielle Johnson
    Department of Molecular and Clinical Pharmacology, University of Liverpool
  • Andrea Jorgensen
    Department of Molecular and Clinical Pharmacology, University of Liverpool
  • Dyfrig Hughes
  • Munir Pirmohamed
    Department of Molecular and Clinical Pharmacology, University of Liverpool
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.

Allweddeiriau

Iaith wreiddiolSaesneg
Rhif yr erthygl42
Nifer y tudalennau19
CyfnodolynJournal of Personalized Medicine
Cyfrol9
Rhif y cyfnodolyn3
Dynodwyr Gwrthrych Digidol (DOIs)
StatwsCyhoeddwyd - 1 Medi 2019

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