Departamento de Investigación, Centro Cochrane Asociado, Instituto Universitario Hospital Italiano, Buenos Aires, Argentina.
Centro Interdisciplinario de Estudios de Salud (CIESAL), Escuela de Medicina, Facultad de Medicina, Universidad de Valparaíso, Valparaíso, Chile.
Medwave. 2020 Jun 5;20(5):e7930. doi: 10.5867/medwave.2020.05.7930.
Sequential analysis of clinical trials allows researchers a continuous monitoring of emerging data and greater security to avoid subjecting the trial participants to a less effective therapy before the inferiority is evident, while controlling the overall error rate. Although it has been widely used since its development, sequential analysis is not problem-free. Among them main issues to be mentioned are the balance between safety and efficacy, overestimation of the effect size of interventions and conditional bias. In this review, we develop different aspects of this methodology and the impact of including early-stopped clinical trials in systematic reviews with meta-analysis.
临床试验的序贯分析允许研究人员对新出现的数据进行持续监测，并提供更大的安全性，以避免在明显劣势之前让试验参与者接受效果较差的治疗，同时控制总体错误率。尽管自开发以来已被广泛应用，但序贯分析并非没有问题。其中主要需要提及的问题是安全性和疗效之间的平衡、干预效果大小的高估以及条件性偏倚。在这篇综述中，我们将探讨这种方法的不同方面，以及在系统评价中纳入早期停止的临床试验对荟萃分析的影响。
