Evidence map›Paper›PMID 31788574›Full record

ArticleContemporary clinical trials communications2019

Biomarker-guided trials: Challenges in practice.

M Antoniou, R Kolamunnage-Dona, J Wason, R Bathia, C Billingham, J M Bliss, L C Brown, A Gillman, J Paul, A L Jorgensen

Abstract read
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In one paragraph

Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing 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

32 citing papers in PubMed.

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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

10 authors.

M AntoniouUniversity of Liverpool, UK.
R Kolamunnage-DonaUniversity of Liverpool, UK.
J WasonNewcastle University and MRC Biostatistics Unit, Cambridge, UK.
R BathiaMRC Clinical Trials Unit at UCL, UK.
C BillinghamUniversity of Birmingham, UK.
J M BlissInstitute of Cancer Research, London, UK.
L C BrownMRC Clinical Trials Unit at UCL, UK.
A GillmanInstitute of Cancer Research, London, UK.
J PaulUniversity of Glasgow, UK.
A L JorgensenUniversity of Liverpool, UK.

Funding

Cancer Research UK 25351Cancer Research UK 25354Medical Research Council MC_UU_00002/6Medical Research Council MR/K025635/1Medical Research Council MR/L004933/1Medical Research Council MR/L006758/1Medical Research Council MR/N028171/1
6 · The paper itself

Abstract

Biomarker-guided trials have drawn considerable attention as they promise to lead to improvements in the benefit-risk ratio of treatments and enhanced opportunities for drug development. A variety of such designs have been proposed in the literature, many of which have been adopted in practice. Implementing such trial designs in practice can be challenging, and identifying those challenges was the main objective of a workshop organised by the MRC Hubs for Trials Methodology Research Network's Stratified Medicine Working Group in March 2017. Participants reflected on completed and ongoing biomarker-guided trials to identify the practical challenges encountered. Here, the key challenges identified during the workshop including those related to funding, ethical and regulatory issues, recruitment, monitoring of samples and laboratories, biomarker assessment, and data sharing and resources, are discussed. Despite the complexities often associated with biomarker-guided trials, the workshop concluded that they can play an important role in advancing the field of personalised medicine. Therefore, it is important that the practical challenges surrounding their implementation are acknowledged and addressed.

Indexed as

BiomarkerChallengesClinical trialPersonalised medicine

Identifiers

PMID31788574
PMCPMC6879976

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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.