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Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy.阿比特龙用于既往未接受过激素治疗的前列腺癌患者
N Engl J Med. 2017 Jul 27;377(4):338-351. doi: 10.1056/NEJMoa1702900. Epub 2017 Jun 3.
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Adding Celecoxib With or Without Zoledronic Acid for Hormone-Naïve Prostate Cancer: Long-Term Survival Results From an Adaptive, Multiarm, Multistage, Platform, Randomized Controlled Trial.在激素初治前列腺癌患者中联合使用塞来昔布(无论是否联合唑来膦酸):一项适应性、多臂、多阶段、平台式随机对照试验的长期生存结果
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ADD-ASPIRIN: A phase III, double-blind, placebo controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours.添加阿司匹林:一项III期、双盲、安慰剂对照、随机试验,评估阿司匹林对常见非转移性实体瘤初始治疗后疾病复发和生存的影响。
Contemp Clin Trials. 2016 Nov;51:56-64. doi: 10.1016/j.cct.2016.10.004. Epub 2016 Oct 21.
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Type I error rates of multi-arm multi-stage clinical trials: strong control and impact of intermediate outcomes.多臂多阶段临床试验的I型错误率:严格控制与中间结果的影响
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Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial.多西他赛、唑来膦酸或两者联合添加至前列腺癌一线长期激素治疗(STAMPEDE):一项适应性、多组、多阶段、平台随机对照试验的生存结果
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Addition of docetaxel or bisphosphonates to standard of care in men with localised or metastatic, hormone-sensitive prostate cancer: a systematic review and meta-analyses of aggregate data.在局限性或转移性激素敏感性前列腺癌男性患者的标准治疗中添加多西他赛或双膦酸盐:汇总数据的系统评价和荟萃分析
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The Brave New World of clinical cancer research: Adaptive biomarker-driven trials integrating clinical practice with clinical research.临床癌症研究的全新世界:由生物标志物驱动的适应性试验,将临床实践与临床研究相结合。
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在 UCL MRC 临床试验单位,10 年来在单一方案中测试多种治疗方法:多臂、多阶段平台、伞式和篮子方案。

Testing many treatments within a single protocol over 10 years at MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols.

机构信息

1 MRC Clinical Trials Unit at UCL, University College London, London, UK.

2 Faculty of Health, Education and Life Sciences, Birmingham City University, Birmingham, UK.

出版信息

Clin Trials. 2017 Oct;14(5):451-461. doi: 10.1177/1740774517725697. Epub 2017 Aug 22.

DOI:10.1177/1740774517725697
PMID:28830236
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5700799/
Abstract

There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone often we find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this article, we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway. Key to all these methods is the aim to test many treatments and/or pose many therapeutic questions within one protocol.

摘要

我们确实需要改变进行某些临床试验的方式,因为目前的测试和开发过程过于缓慢、成本过高且容易失败——我们经常发现新的治疗方法并不比现有标准更好。在开发和测试途径上的大部分重点都集中在改进 I 期和 II 期试验的设计上。在本文中,我们提出了改进 III 期试验设计(以及必要的前期准备)的新方法示例,因为它们是该途径中最耗时和最昂贵的部分。所有这些方法的关键都是旨在在一个方案中测试多种治疗方法和/或提出许多治疗问题。