Randomized trials, which sit at the top of the evidence-based medicine pyramid, are the gold standard approach to establishing causal inference between treatment and outcomes. Both phase 3 trials and randomized phase 2 trials rely on properly conceived and implemented randomization methods, without which selection and accidental bias may preclude firm conclusions. Moreover, phase 1 trials are increasingly randomized in this era of precision medicine and multiple competing treatment schedules that may be developed. Depending on trial size and goals, simple randomization, stratified randomization with permuted blocks, and dynamic methods of treatment allocation, including minimization, can be used to ensure properly balanced treatment arms with respect to known and unknown prognostic factors. The need for blinding adds a further layer of complexity, and additional issues come into play for randomized trials requiring this feature.
Contents of the webinar:
- Rationale for the various randomization methods, with illustration from real clinical trials and some considerations about the performance characteristics of the different methods.
- Logistic issues related to the implementation of the various randomization methods.
- Best practices to ensure that this implementation is done in a way that is faithful to the chosen method of randomization and that guarantees the trial integrity from beginning to end, without which the scientific and regulatory aspects of the trial may be jeopardized.

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