Emerging innovations in clinical trial design
Emerging innovations in clinical trial design
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DOI：
10.1002/cpt.285
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发表时间：
2016-01-01
影响因子：
6.7
通讯作者：
Berry, D. A.
中科院分区：
文献类型：
--
作者：
Berry, D. A.
自20世纪40年代随机化出现以来，临床试验的设计几乎没有改变。现代设计创新是由临床研究中越来越多的认识所驱动的，即疾病是异质性的，显然患有相同疾病的患者需要不同的治疗方法。本文介绍了一些创新的临床试验设计跨治疗领域，但重点是肿瘤学。没有人知道临床试验设计的未来会怎样，但假装患者人群是同质的大型试验的现状无论是在经济上还是在科学/医学上都是不可持续的。没有人知道最终的商业模式和监管模式会是什么，但它们将与今天的模式大不相同。
Designs of clinical trials have changed little since the advent of randomization in the 1940s. Modern innovations in designs are being driven by the increasing recognition in clinical research that diseases are heterogeneous and patients who apparently have the same disease require different therapies. This article describes some innovations in clinical trial design across therapeutic areas but with a focus on oncology. No one knows what the future holds for clinical trial design but the status quo of large trials that pretend the patient population is homogeneous is not sustainable, either economically or scientifically/medically. No one knows what the eventual business model and regulatory model will be, but they will be very different from today's.