ich e9 (statistical principles for clinical trials)

What Statistical Methods are Recommended?

The guideline recommends using appropriate statistical methods to address the research questions posed by the trial. For cancer clinical trials, this often involves advanced techniques such as survival analysis (e.g., Kaplan-Meier curves, Cox proportional hazards model) and methods to handle missing data. The use of interim analyses and adaptive designs is also discussed, which can be particularly useful in oncology to make timely decisions about the continuation or modification of a trial based on emerging data.

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