Biomarker-guided trials: Challenges in practice
Biomarker-guided trials: Challenges in practice
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DOI：
10.1016/j.conctc.2019.100493
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发表时间：
2019-12-01
影响因子：
1.5
通讯作者：
Jorgensen, A. L.
中科院分区：
文献类型：
--
作者：
Antoniou, M.;Kolamunnage-Dona, R.;Jorgensen, A. L.
生物标志物引导的试验已经引起了相当大的关注，因为它们有望改善治疗的收益-风险比，并增加药物开发的机会。文献中提出了各种这样的设计，其中许多已在实践中采用。在实践中实施这样的试验设计可能具有挑战性，并且确定这些挑战是MRC试验方法学研究网络分层医学工作组于2017年3月组织的研讨会的主要目标。参与者反思已完成和正在进行的生物标志物指导试验，以确定遇到的实际挑战。在这里，讨论了研讨会期间确定的主要挑战，包括与资金，道德和监管问题，招聘，样品和实验室监测，生物标志物评估以及数据共享和资源相关的挑战。尽管生物标志物引导的试验通常具有复杂性，但研讨会得出的结论是，它们可以在推进个性化医疗领域发挥重要作用。因此，重要的是要承认和解决围绕其实施的实际挑战。
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.