Biomarker-guided trials: Challenges in practice.
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ICR Authors
Authors
Antoniou, M
Kolamunnage-Dona, R
Wason, J
Bathia, R
Billingham, C
Bliss, JM
Brown, LC
Gillman, A
Paul, J
Jorgensen, AL
Kolamunnage-Dona, R
Wason, J
Bathia, R
Billingham, C
Bliss, JM
Brown, LC
Gillman, A
Paul, J
Jorgensen, AL
Document Type
Journal Article
Date
2019-12-01
Date Accepted
2019-11-13
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.
Citation
Contemporary clinical trials communications, 2019, 16 pp. 100493 - ?
Source Title
Publisher
ELSEVIER INC
ISSN
2451-8654
eISSN
2451-8654
Collections
Research Team
Clinical Trials & Statistics Unit