Evidence map›Paper›PMID 31480618›Full record

ReviewJournal of personalized medicine2019

Evidence to Support Inclusion of Pharmacogenetic Biomarkers in Randomised Controlled Trials.

Danielle Johnson, Dyfrig Hughes, Munir Pirmohamed, Andrea Jorgensen

Abstract readReview
In one paragraph

Review in Journal of personalized medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Danielle JohnsonInstitute of Translational Medicine, Department of Biostatistics, University of Liverpool, Waterhouse Building, 1-5 Brownlow Street, Liverpool L69 3GL, UK. danielle.johnson@liverpool.ac.uk.ORCID 0000-0001-7820-1687
Dyfrig HughesCentre for Health Economics and Medicines Evaluation, Bangor University, Ardudwy, Normal Site, Bangor LL57 2PZ, UK.ORCID 0000-0001-8247-7459
Munir PirmohamedMRC 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.ORCID 0000-0002-7534-7266
Andrea JorgensenInstitute of Translational Medicine, Department of Biostatistics, University of Liverpool, Waterhouse Building, 1-5 Brownlow Street, Liverpool L69 3GL, UK.

Funding

Medical Research Council G0800792Medical Research Council MR/K025635/1Medical Research Council MR/L004933/1Medical Research Council MR/L004933/2Medical Research Council MR/L004933/2- R19Medical Research Council MR/L006758/1
6 · The paper itself

Abstract

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.

Indexed as

adverse drug reactionsbiomarkerevidencepharmacogeneticsRCT

Identifiers

PMID31480618
PMCPMC6789450

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.