STATSOLS Webinar: Randomization in Clinical Trials - Understanding it's importance & a guide to generating randomization lists - Brian Ronayne

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Randomization of subjects between treatment groups in a clinical trial is an essential statistical element that allows one to claim that a study will be unbiased. In this webinar we look at the benefits that randomization provides and examine the properties of three well known algorithms for generating randomization lists: block randomization, complete randomization and Efron’s biased coin randomization.

In this webinar, you will learn about:

• Benefits of Randomization in Clinical Trials
• Different Randomization List Algorithms
• How to select the correct Randomization List Algorithm

A pivotal component for most clinical trials is randomization i.e. the random assignment of patients to receive either the experimental treatment(s) or controls. Without randomization, it can be difficult to ensure statistical comparability for the treatment effect between the different groups being compared. Blinded randomization also prevents operational bias due to trialists’ expectations influencing treatment assignment. Both of these could strongly distort the results of the study.

Many algorithms exist for implementing randomization in a clinical trial. While Complete Randomization (equivalent to assigning treatment via coin toss) or its variants (such as Efron’s Biased Coin) are sometimes used, in many clinical trials other algorithms are usually used to ensure that the influence of time-varying treatment effects or important covariates can be accounted for. For example the most widely used randomization algorithm, Block Randomization, prevents long runs of single group assignment and can account for stratified randomization on important covariates such as age.

In this webinar we will discuss the reasons why randomization is such an important part of clinical trial design, compare the three algorithms available for randomization (Block Randomization, Complete Randomization, Efron’s biased coin randomization) and provide a practical tutorial of how software can be used to generate randomization lists in a quick and flexible manner.