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Biomarker-guided trials: Challenges in practice

Antoniou, M; Kolamunnage-Dona, R; Wason, J; Bathia, R; Billingham, C; Bliss, JM; Brown, LC; ... Jorgensen, AL; + view all (2019) Biomarker-guided trials: Challenges in practice. Contemporary Clinical Trials Communications , 16 , Article 100493. 10.1016/j.conctc.2019.100493. Green open access

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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.

Type: Article
Title: Biomarker-guided trials: Challenges in practice
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.conctc.2019.100493
Publisher version: https://doi.org/10.1016/j.conctc.2019.100493
Language: English
Additional information: © 2019 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Keywords: Clinical trial, Biomarker, Challenges, Personalised medicine
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10087735
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