Trial Design
Randomization
Randomization is the process of assigning clinical trial participants to treatment groups by chance, eliminating selection bias and producing comparable groups for unbiased estimation of treatment effects.
Common methods include simple randomization, block randomization (preserves balance over time), stratified randomization (balances key prognostic factors across arms), and minimization (dynamically balances multiple covariates). Adaptive designs may use response-adaptive randomization to direct more patients toward better-performing arms.
Randomization is implemented via Interactive Response Technology (IRT/IWRS) systems that maintain blinding and integrate with EDC and drug supply.
Related terms
Blinding (Masking)
Blinding (also called masking) is the practice of withholding information about treatment assignment from one or more parties in a clinical trial to prevent bias in outcome assessment, behavior, and analysis.
Adaptive Trial Design
An adaptive trial design is a clinical trial that uses pre-specified rules to modify aspects of the study (sample size, randomization ratio, dose, treatment arms, endpoints) based on accumulating interim data, without compromising scientific validity.
Endpoint (Clinical Trial)
A clinical trial endpoint is a defined, measurable outcome that determines whether the intervention being studied has the intended effect; it is the variable on which the trial's success or failure is statistically evaluated.
Intention-to-Treat (ITT) Analysis
Intention-to-treat (ITT) analysis is a statistical principle requiring that all randomized participants be analyzed in the treatment group to which they were originally assigned, regardless of whether they completed, switched, or never received the assigned treatment.
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