Cautions as Regulators Move to End Exclusive Reliance on Intention to Treat

Intention-to-treat (ITT) analyses of randomized trials have been favored because they alleviate concerns about baseline confounding, but ITT analyses estimate the effect of being assigned to an intervention rather than that of actually receiving it. Regulators, pharmaceutical companies, and academics are advocating approaches to complement ITT analyses. This commentary presents specifications to consider for such approaches.

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