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Analytix Thinking

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Articles

Estimand Endpoints for Longitudinal Measures of Continuous Disease Progression with an Alzheimer’s Disease Example - Therapeutic Innovation & Regulatory Science

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By Analytix Thinking
| link.springer.com
Abstract The ICH E9 (R1) Addendum provides a framework to define an estimand and perform sensitivity analysis. The clinical endpoint (i.e., variable, response, outcome) is one of the important estimand attributes. In our opinion, the selection of the endpoint in Alzheimer’s disease requires more exploration beyond what is used currently.
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A platform for comparing subgroup identification methodologies

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By Stephen J. Ruberg, Ying Zhang, Analytix Thinking, Hollins Showalter
| Wiley Online Library Verified
Final remarks Subgroup analysis is routine for randomized controlled trials; in fact, one can argue that statisticians are obliged to analyze clinical trial data in many ways to glean as much information as possible from such large, expensive, and time-consuming endeavors. The difficulty is in how to interpret any subgroup findings.
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