Abstract

The randomized control trial (RCTs) is widely accepted to be the best design for evaluating the efficacy of new therapies, and thus it is accepted as the gold standard to evaluate treatment effects. Random assignment of patients to the treatment ensures the internal validity of the comparison of new treatment with a control group. Unfortunately, the randomization process in most research studies is not implemented properly. The purpose of this review is to provide researchers and scholarly clinicians with a better understanding of different options to achieve proper randomization. The information presented in this article will also help to better design and interpret the results of clinical trials. Therefore, a brief definition of randomization plus its concise benefits in clinical trials, and the processes of an accurate randomization procedure, generation of unpredictable random allocation sequence and allocation concealment are considered. Recommendations are made to select the suitable techniques of generation of random allocation and allocation concealment. Finally, the authors describe how the appropriate implementation of these two procedures reduces the potential for biases throughout the study and improves the power of the study.

Highlights

  • Randomized controlled trial (RCT) is defined as a clinical trial in which the participants are assigned randomly to different treatments groups

  • Randomized experimental design is the preferred method of research for evaluating treatment effects in health research since it provides the highest degree of control over a research study and allows the researcher to draw causal inferences with the highest degree of confidence [1]

  • The increasing recognition toward using randomized control trials (RCT) in health care started in the 20th century

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Summary

Introduction

Randomized controlled trial (RCT) is defined as a clinical trial in which the participants are assigned randomly to different treatments groups. Randomized experimental design is the preferred method of research for evaluating treatment effects in health research since it provides the highest degree of control over a research study and allows the researcher to draw causal inferences with the highest degree of confidence [1]. They use a systematic methodology that allows controlling for confounder variables [2]. Randomization minimizes the differences among groups by distributing participants with particular characteristics among all the trial arms It is a curial procedure in RCTs without which the treatment effect could be overestimated by up to 41% [8]. The content of this paper will help researchers in the area of health sciences to understand how randomization and allocation concealment operate and decrease several flaws regarding knowledge when analyzing, criticizing, and designing future trials

Benefits of Randomization
Generation of Allocation Sequence’s
Stratified Randomization
Covariate Adaptive Randomization
Summary of Random Allocation Sequence
Allocation Concealment
The Effect of Randomization on Power of the Study
Findings
Conclusion
Full Text
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