Vickers Andrew J
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
J Soc Integr Oncol. 2006 Fall;4(4):194-8. doi: 10.2310/7200.2006.023.
Randomized trials are an important method for deciding whether integrative oncology therapies do more good than harm. Many investigators do not pay sufficient attention to randomization procedures, and several studies have shown that only a fraction of trial reports describe randomization adequately. The purpose of randomization is to prevent selection bias: randomization procedures must therefore ensure that researchers are unable to predict the group to which a patient will be randomized until the patient is unambiguously registered on study; moreover, researchers must be unable to change a patient's allocation after the patients are registered. The use of telephone randomization and opaque envelopes has been suggested as a good randomization method, but both can be subverted. Randomization should be conducted either by a pharmaceutical company, which sends blinded medication to the hospital pharmacy, or by a secure, password-protected database system. Computer randomization can easily incorporate extensions of randomization, such as blocking, stratification, and minimization, which can help ensure balance between groups.
随机试验是判定整合肿瘤治疗方法利大于弊的重要方法。许多研究者对随机化程序不够重视，多项研究表明，只有一小部分试验报告充分描述了随机化过程。随机化的目的是防止选择偏倚：因此，随机化程序必须确保研究人员在患者明确登记入组前无法预测其将被随机分配到的组；此外，在患者登记后，研究人员不得更改其分配。有人建议使用电话随机化和不透明信封作为良好的随机化方法，但两者都可能被破坏。随机化应由制药公司进行，由其将盲法药物发送至医院药房，或者通过安全的、有密码保护的数据库系统进行。计算机随机化可以轻松纳入随机化的扩展方法，如区组随机化、分层随机化和最小化随机化，这些方法有助于确保组间平衡。
