SEMINAR: Current trends and open questions in dealing with treatment non-adherence and missing data in the clinical trials regulatory environment

Bohdana Ratitch, PhD Scientific Advisor, Data Mining & Statistical Analysis, Advisory Analytics Group - Quintiles IMS Current trends and open questions in dealing with treatment non-adherence and missing data in the clinical trials regulatory environment Tuesday, 21 February 2017 3:30 pm – 4:30 pm - Purvis Hall, 1020 Pine Ave. West, Room 24

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Abstract: In recent years, members of the clinical research community have been promoting the use of estimands as a way to link high-level clinical trial objectives to analysis strategies, while providing a clear pre-specification of how non-adherence to randomized treatment, e.g., early discontinuation or initiation of rescue therapy, will be accounted for in the estimate of treatment effect. In practice, even with well-defined estimands and well-designed trials, some amount of missing data can be expected, or it may be impossible to obtain usable (non-confounded) data for a specific estimand for some subjects during the periods of non-adherence. This presentation will review missing data treatment in light of the current regulatory landscape. We will discuss the evolution of thinking regarding what constitutes a useful estimand for different decision makers, usability of data during treatment non-adherence, some common analysis strategies, and open questions. 

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