Biomarker-guided trials: Challenges in practice


Antoniou, M, Kolamunnage-Dona, R ORCID: 0000-0003-3886-6208, Wason, J, Bathia, R, Billingham, C, Bliss, JM, Brown, LC, Gillman, A, Paul, J and Jorgensen, AL ORCID: 0000-0002-6977-9337 (2019) Biomarker-guided trials: Challenges in practice. Contemporary Clinical Trials Communications, 16. p. 100493.

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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.

Item Type: Article
Uncontrolled Keywords: Clinical trial, Biomarker, Challenges, Personalised medicine
Depositing User: Symplectic Admin
Date Deposited: 04 Dec 2019 09:07
Last Modified: 19 Jan 2023 00:17
DOI: 10.1016/j.conctc.2019.100493
Open Access URL: https://doi.org/10.1016/j.conctc.2019.100493
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3064592
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