Quality assurance of randomization in clinical trials

Abstract

Abstract: Randomization is one of the effective procedures avoiding selection bias in randomized controlled clinical trials.Quality assurance of the randomization is crucial to improve the quality of clinical trials.Successful implementation of randomization depends on two interrelated aspects.The first is the generation of unpredictable random allocation sequence which prevent researchers, clinicians, and patients from predicting.The second is allocation concealment which conceals the upcoming allocation sequence from researchers and participants.Based on introducing the concept of randomization, the techniques of generating random sequence and allocation concealment used in clinical trials are reviewed and described.Meanwhile, the contents and requirements reporting randomization are provided, hoping to improve the quality of reporting randomized controlled clinical trials in China.

Key words: clinical trial, randomization, random allocation, allocation concealment, quality assurance

CLC Number:

R311

LIU Yu-xiu. Quality assurance of randomization in clinical trials[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(7): 721-725.

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