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Abstract:
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Statistical issues in trials in rheumatology conditions such as rheumatoid arthritis (RA) and psoriatic arthritis (PsA) will be discussed within the purview of clinical development of drug products. Impacts of design features on statistics-including patient population, control group, background treatment, rescue, or escape treatment-and key efficacy endpoints will be discussed. In addition, we will discuss statistical methods such as defining the estimand (e.g., ITT or de facto), handling escape and/or missing data, sensitivity analyses, analytic models, multiplicity adjustment for secondary endpoints proposed for inclusion in the product label, etc. Also, we will briefly discuss features of analysis-ready data sets (ADaM) relating to recent work of the RA therapeutic area user guide (TAUG) group of CFAST.
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