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首页> 外文期刊>British Journal of Cancer >Effective delivery of Complex Innovative Design (CID) cancer trials—A consensus statement
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Effective delivery of Complex Innovative Design (CID) cancer trials—A consensus statement

机译:有效地提供复杂的创新设计(CID)癌症试验 - 同意声明

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The traditional cancer drug development pathway is increasingly being superseded by trials that address multiple clinical questions. These are collectively termed Complex Innovative Design (CID) trials. CID trials not only assess the safety and toxicity of novel anticancer medicines but also their efficacy in biomarker-selected patients, specific cancer cohorts or in combination with other agents. They can be adapted to include new cohorts and test additional agents within a single protocol. Whilst CID trials can speed up the traditional route to drug licencing, they can be challenging to design, conduct and interpret. The Experimental Cancer Medicine Centres (ECMC) network, funded by the National Institute for Health Research (NIHR), Cancer Research UK (CRUK) and the Health Boards of Wales, Northern Ireland and Scotland, formed a working group with relevant stakeholders from clinical trials units, the pharmaceutical industry, funding bodies, regulators and patients to identify the main challenges of CID trials. The working group generated ten consensus recommendations. These aim to improve the conduct, quality and acceptability of oncology CID trials in clinical research and, importantly, to expedite the process by which effective treatments can reach cancer patients.
机译:传统的癌症药物开发途径越来越多地通过解决多种临床问题的试验来取代。这些是集体称为复杂的创新设计(CID)试验。 CID试验不仅评估了新的抗癌药物的安全性和毒性,而且还评估了它们在生物标志物 - 选择的患者,特异性癌症队列或与其他药剂组合的疗效。它们可以适用于在单个协议内包括新的队列和测试额外的代理。虽然CID试验可以加快传统的毒品途径,但它们可能挑战设计,进行和解释。由国家卫生研究所(NIHR),癌症研究英国(Cruk)和威尔士,北爱尔兰和苏格兰威尔士卫生委员会资助的实验癌症中心(ECMC)网络成立了一个来自临床试验的相关利益攸关方的工作组单位,制药行业,融资机构,监管机构和患者确定CID试验的主要挑战。工作组产生了十大共识建议。这些旨在改善临床研究中肿瘤CID试验的行为,质量和可接受性,重要的是,为了加快有效治疗可以到达癌症患者的过程。

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