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Getting the Questions Right
Session Chair(s)
Yeh-Fong Chen, PhD
Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER
United States
Seating is limited
Randomized clinical trials are often considered the gold standard in drug development to assess efficacy and safety of a new treatment as they are expected to be free from baseline confounding. However, randomisation does not protect from bias due to events that occur after randomisation, e.g. discontinuation of treatment, treatment switching etc. At present, these post-randomisation events are dealt with implicitly as a consequence of choices made about the data collection and statistical analysis.
In this content hub, we would like to engage with peers and discuss some of the issues and key solutions to improve transparency and ensure alignment between trial objectives and statistical approaches in clinical trials. We will also present what the DIA Communities are doing to address this topic.
Learning Objective : Describe some of the challenges in the analysis and interpretation of clinical trial results; Discuss how to improve transparency and ensure alignment between trial objectives and statistical approaches in clinical trials.
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