Bayesian clinical trials at the University of Texas M. D. Anderson Cancer Center.
Bayesian clinical trials at the University of Texas M. D. Anderson Cancer Center.
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DOI：
10.1177/1740774509104992
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发表时间：
2009-06
期刊：
影响因子：
--
通讯作者：
Berry DA
中科院分区：
文献类型：
--
作者：
Biswas S;Liu DD;Lee JJ;Berry DA
贝叶斯方法越来越多地用于医学研究。特别是，它已经成为德克萨斯大学M。D.安德森癌症中心。为了说明在M. D.安德森，我们审查了2000年至2005年初在方案文件在线系统中注册的方案。我们总结了我们的研究结果，并详细介绍了三个创新的试验，这些试验代表了贝叶斯方法在中心发挥了重要作用。在审查的964个方案中，59%仅在M进行。D.安德森和其他人是多中心试验。贝叶斯设计和分析被用于约20%（195/964）的协议，我们审查。在520个被确定为I期或II期药物试验的方案中，约34%是贝叶斯的。195个贝叶斯试验中的大多数是由M. D.安德森统计学家。最常用的贝叶斯设计特征是I期（毒性）试验中的连续再评估方法、II期试验中的适应性随机化以及同时监测疗效和毒性的设计。我们还提供了一个内部人士的意见，一些实际的考虑，使设计和实施这么多的贝叶斯试验成为可能。我们只回顾了所有M的一个子集。D.安德森协议，但不排除任何可用的电子形式。在M. D.安德森证明了贝叶斯方法在中心内的接受度，包括主要研究者、监管审查委员会和患者。采用贝叶斯观点的统计学家可以成功地在临床试验设计中建立创新文化。
The Bayesian approach is being used increasingly in medical research. In particular, it has become a standard in designing clinical trials at the University of Texas M. D. Anderson Cancer Center. To address the extent and nature of Bayesian trials conducted at M. D. Anderson, we reviewed the protocols registered in the Protocol Document Online System between 2000 and early 2005. We summarize our findings and give details for three innovative trials that typify those in which a Bayesian approach has played a major role at the center. Of 964 protocols reviewed, 59% were conducted solely at M. D. Anderson and the rest were multicenter trials. Bayesian designs and analyses were used in about 20% (195/964) of the protocols that we reviewed. Of the 520 protocols identified as phase I or II drug trials, about 34% were Bayesian. Most of the 195 Bayesian trials were designed by M. D. Anderson statisticians. The Bayesian design features most commonly used were the continuous reassessment method in phase I (toxicity) trials, adaptive randomization in phase II trials, and designs to monitor efficacy and toxicity simultaneously. We also provide an insider's view regarding some practical considerations that have made the design and implementation of so many Bayesian trials possible. We reviewed only a subset of all M. D. Anderson protocols, but did not exclude any available in electronic form. The large number of Bayesian trials conducted at M. D. Anderson testifies to the receptivity to the Bayesian approach within the center, including principal investigators, regulatory review committees, and patients. Statisticians who take a Bayesian perspective can successfully work to establish a culture of innovation in clinical trial design.
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DOI：
10.1198/016214504000000052
发表时间：
2004-03-01
影响因子：
3.7
作者：
Berry, SM;Berry, DA;Belder, R
通讯作者：
Belder, R
影响因子：
2.7
作者：
Berry, DA
通讯作者：
Berry, DA
影响因子：
1.1
作者：
Hobbs, Brian P.;Carlin, Bradley P.
通讯作者：
Carlin, Bradley P.
影响因子：
45.3
作者：
Giles, FJ;Kantarjian, HM;Estey, EH
通讯作者：
Estey, EH
影响因子：
5.7
作者：
Berry, DA
通讯作者：
Berry, DA