Srijithesh P R, Husain Shakir
Department of Neurology, National Institute of Mental Health and Neuroscience, Bangalore, India.
Department of Neuroradiology, University Hospital Zürich, Zurich, Switzerland.
Ann Indian Acad Neurol. 2020 May-Jun;23(3):249-252. doi: 10.4103/aian.AIAN_15_20. Epub 2020 Jun 5.
The interpretation of the results of clinical trials should be done by examining the finer prints of extraneous factors such as stopping rules, interim analysis, intricacies of patient selection, and the rationale of decisions that lead to non-prespecified termination. This can be done only by critical education in the art and science of interpretation of evidence emerging from clinical trials. The pioneering pivotal studies, namely, NINDS rtPA and ECASS III trials, hold disproportionate influence in determining the contours of the subsequent fate of clinical trials and treatment guidelines. It needs to be recognized that the pooling of studies using dissimilar trial designs, notwithstanding similar patient profiles, would undermine the positive signal emerging from the studies that have used better selection methodologies to homogenize the study population.
临床试验结果的解读应通过审视诸如终止规则、期中分析、患者选择的复杂性以及导致非预先指定终止的决策依据等外部因素的细节来进行。这只能通过对临床试验证据解读的艺术和科学进行批判性教育来实现。开创性的关键研究,即美国国立神经疾病与中风研究所(NINDS)的rtPA试验和欧洲急性卒中协作研究III期(ECASS III)试验,在决定后续临床试验和治疗指南的走向方面具有不成比例的影响力。需要认识到,尽管患者特征相似,但使用不同试验设计的研究汇总,会削弱那些采用更好选择方法以使研究人群同质化的研究中出现的积极信号。