Ajmera Yamini, Singhal Sunny, Dwivedi S N, Dey A B
Department of Geriatric Medicine, AIIMS, New Delhi, India.
Department of Biostatistics, AIIMS, New Delhi, India.
Perspect Clin Res. 2021 Apr-Jun;12(2):66-71. doi: 10.4103/picr.PICR_138_20. Epub 2021 Jan 8.
Maintaining health and well-being of the population is a universal priority. Governments around the globe are therefore seeking greater efficiency and better outcomes from researches being held. Although large randomized trials or systematic review of several large trials provides the highest level of evidence, the intricate cost, time, and difficulties of conventional trials have led to questions about their sustainability commanding search for alternative approaches. Demands for improved competences in medical research have led to mounting interest in newer clinical trial designs. This article provides an insight into newer clinical trial designs, including cluster trials, adaptive designs, the master protocols along with their strengths, weaknesses, and which trials design should be opted for in different clinical scenarios.
维护民众的健康和福祉是一项全球普遍的优先事项。因此,世界各国政府都在寻求提高正在进行的研究的效率并取得更好的成果。尽管大型随机试验或对多个大型试验的系统评价提供了最高级别的证据,但传统试验复杂的成本、时间和困难引发了对其可持续性的质疑,促使人们寻找替代方法。对提高医学研究能力的需求导致对更新的临床试验设计的兴趣日益浓厚。本文深入探讨了更新的临床试验设计,包括整群试验、适应性设计、主方案,以及它们的优点、缺点,以及在不同临床场景中应选择哪种试验设计。