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Randomization in clinical trials: time for fresh consideration?

Published on July 31, 2024   42 min

Other Talks in the Series: The Risk of Bias in Randomized Clinical Trials

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0:00
Hello everyone, my name is Oleksandr Sverdlov, and I'm a Senior Director of Biostatistics at Novartis. Today, my presentation is on Randomization in Clinical Trials: Time for Fresh Consideration?
0:17
Here's the outline of my presentation. I'll start with some background on randomization in clinical trials. Then I'll describe the balance-randomness tradeoff. Then I'll talk about validity and efficiency considerations. After that, I'll describe the importance of covariate adjustment in the context of randomized clinical trials. Finally, some additional important topics on randomization.
0:47
Here's the background on randomization in clinical trials.
0:53
Some historical perspective on randomization. We are really standing on the giant's shoulders. The work of Ronald Fisher, "The Design of Experiments", Sir Bradford Hill's work, and Jerome Cornfield's work, "Principles of Research", they all form an important basis for the theoretical approach on randomization method.
1:19
Why is randomization important in clinical trials? There are three main reasons. The first one is that randomization helps mitigate selection bias in the design. Especially when the study is an open-label study. Second, randomization promotes the similarity of treatment groups with respect to known and unknown confounders. Third, it contributes to the validity of statistical estimators and tests, and in fact, it can form the basis for re-randomization tests. What are other important considerations

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Randomization in clinical trials: time for fresh consideration?

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