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Key Issues in Analyzing Treatment Approaches: Eligibility and Compliance Considerations

This overview outlines essential elements in the analysis of treatment approaches for subjects in clinical trials. We explore critical questions such as who gets analyzed and how subjects are grouped for analysis. We differentiate between two primary analysis methods: Per Protocol, which focuses on fully compliant subjects with no missing data, and Intention to Treat, which analyzes all randomized subjects using available data. Understanding these methodologies is vital for interpreting clinical trial results and ensuring valid conclusions.

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Key Issues in Analyzing Treatment Approaches: Eligibility and Compliance Considerations

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    1. Key Issues in Analysis Who gets analyzed? How are they grouped for analysis?

    2. Approaches “Treatment received” (also referred to as “per protocol” or “as treated”) Analyze only fully eligible and compliant subjects with no missing data, e.g., “valid” and “evaluable” subjects “Intention to treat” (also referred to as “full analysis” set and “as randomized”) Analyze all randomized subjects utilizing as much information from each as possible

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