Charlton B G
Department of Psychology, University of Newcastle upon Tyne.
Br J Gen Pract. 1996 Jul;46(408):429-31.
Despite their prestige, megatrials are founded upon a methodological error. This is the assumption that randomization of very large numbers of subjects can compensate for deliberately reduced levels of experimental control, but there is no trade-off between size and rigour. Randomized trials are not a 'gold standard' because no method is intrinsically valid-there are good and bad trials. Interpretation of megatrials is always difficult and requires considerable clinical and scientific knowledge. Three fundamental parameters should be considered when evaluating the applicability of a trial to clinical practice: rigour of design; representativeness of the trial population; and homogeneity of the recruited subjects.
尽管大型试验享有盛誉，但它们基于一个方法学错误。即认为对大量受试者进行随机分组可以弥补故意降低的实验控制水平，但规模与严谨性之间不存在权衡。随机试验并非“金标准”，因为没有哪种方法本质上就是有效的——试验有好有坏。对大型试验的解读总是困难的，需要相当多的临床和科学知识。在评估一项试验对临床实践的适用性时，应考虑三个基本参数：设计的严谨性；试验人群的代表性；以及所招募受试者的同质性。
