Department of Pharmacology, Adesh Institute of Medical Sciences and Research, Bathinda - 151 109, Punjab, India.
Indian J Pharmacol. 2010 Aug;42(4):201-7. doi: 10.4103/0253-7613.68417.
New drug development is a time-consuming and expensive process. Recently, there has been stagnation in the development of novel compounds. Moreover, the attrition rate in clinical research is also on the rise. Fearing more stagnation, the Food and Drug Administration released the critical path initiative in 2004 and critical path opportunity list in 2006 thus highlighting the need of advancing innovative trial designs. One of the innovations suggested was the adaptive designed clinical trials, a method promoting introduction of pre-specified modifications in the design or statistical procedures of an on-going trial depending on the data generated from the concerned trial thus making a trial more flexible. The adaptive design trials are proposed to boost clinical research by cutting on the cost and time factor. Although the concept of adaptive designed clinical trials is round-the-corner for the last 40 years, there is still lack of uniformity and understanding on this issue. This review highlights important adaptive designed methodologies besides covering the regulatory positions on this issue.
新药开发是一个耗时且昂贵的过程。最近，新型化合物的开发陷入了停滞。此外，临床研究的淘汰率也在上升。为了避免更多的停滞，美国食品和药物管理局于 2004 年发布了关键路径倡议，2006 年发布了关键路径机会清单，从而强调了推进创新试验设计的必要性。其中一项创新建议是适应性设计临床试验，这是一种根据相关试验产生的数据，在设计或统计程序中预先规定修改的方法，从而使试验更加灵活。适应性设计试验旨在通过降低成本和时间因素来促进临床研究。虽然自适应设计临床试验的概念已经存在了 40 年，但在这一问题上仍然缺乏统一性和理解。除了涵盖这个问题的监管立场外，这篇综述还强调了重要的适应性设计方法学。
