RANDOMIZATION AND STRATIFICATION OF PATIENTS TO CLINICAL TRIALS

RANDOMIZATION AND STRATIFICATION OF PATIENTS TO CLINICAL TRIALS
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DOI:
10.1016/0021-9681(74)90015-0
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发表时间:
1974-01-01
期刊:
JOURNAL OF CHRONIC DISEASES
影响因子:
--
通讯作者:
ZELEN, M
ZELEN, M
中科院分区:
其他
文献类型:
--
作者:
ZELEN, M

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随机对照临床试验在临床研究者中获得了广泛的认可,用于评估新疗法和标准疗法的治疗获益。在临床试验的背景下,术语“随机化”是指使用随机程序将治疗分配给患者。这种随机过程是指,在患者登记参加研究时,研究者和患者都不知道将分配的治疗。通常,使用随机数字表进行随机分配。一个随机数的表是一个简单的表,具有数字0-9,使得每个数字在每个条目中出现的机会相同。这是一个可以“没有错误”的表,因为每个数字都应该是随机放置的。这些表格用于生成随机化时间表。表l是一本随机数书的样本页。
RANDOMIzED controlled clinical trials have gained widespread acceptance among clinical investigators for evaluating the therapeutic benefits of new as well as standard therapies. The term “randomization', in the context of clinical trials, refers to the assignment of treatments to patients using a chance procedure. This chance procedure is such that neither the investigator nor the patient knows the treatment to be assigned at the time a patient is registered for the study.Usually a randomization assignment is made using a table of random numbers. A table of random numbers is simply a table having the digits 0–9 such that each digit has the same chance of appearing in every entry. This is a table where there can be “no errors' because every digit is supposed to be randomly placed. It is such tables which are used to generate randomization schedules. Table l is a sample page from a book of random numbers.