THE CONTROLLED SINGLE SUBJECT TRIAL
THE CONTROLLED SINGLE SUBJECT TRIAL
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DOI：
10.3109/02813439109026576
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发表时间：
1991-01-01
影响因子：
2.1
通讯作者：
FOSSTVEDT D
中科院分区：
文献类型：
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作者：
JOHANNESSEN T;PETERSEN H;FOSSTVEDT D
在单个受试者中进行的随机对照试验（"1个随机对照试验“）是双盲、多交叉试验，其中在一个个体中比较两种或多种治疗的效果。其目的是提供一种新药在特定患者中疗效的受控评估。适用于单一受试者试验的疾病尤其是那些显著损害生活质量且治疗效果不确定的疾病。适当的药物应具有迅速的作用，最小的遗留效应，并且没有副作用。试验设计由连续治疗期的长度、数量和顺序、结局指标和统计学要求决定。这些元素中的每一个都可以根据临床实体和所应用的药物进行改变和定制，从而为设计选项提供了很大的潜力。
Randomized controlled trials in single subjects ('N of 1 RCT') are double-blind, multi crossover trials in which the effects of two or more treatments are compared within one individual. The aim is to provide a controlled assessment of the efficacy of a new drug in a specific patient. Suitable diseases for single subject trials are particularly those which significantly impair the quality of life and in which there are uncertain treatment effects. Appropriate drugs should have a prompt action, a minimum of carry-over effect, and no side-effects. The trial design is determined by length, number, and order of successive treatment periods, the outcome measures, and the statistical requirements. Each of these elements may be altered and tailored to the clinical entity and drugs(s) applied, thus, providing a large potential for design options.