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Biomarker-guided trials: Challenges in practice.

Published version
Peer-reviewed

Type

Article

Change log

Authors

Antoniou, M 
Kolamunnage-Dona, R 
Bathia, R 
Billingham, C 

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.

Description

Keywords

Biomarker, Challenges, Clinical trial, Personalised medicine

Journal Title

Contemp Clin Trials Commun

Conference Name

Journal ISSN

2451-8654
2451-8654

Volume Title

16

Publisher

Elsevier BV
Sponsorship
MRC (unknown)
Medical Research Council (MR/N028171/1)
Medical Research Council (MR/K025635/1)