Guided Notes

Clinical Trial Design Essentials

Endpoints, randomization, blinding, control groups, inclusion/exclusion criteria, sample size basics and study designs (parallel, crossover, adaptive) — and what each means for the data.

Endpoints

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Endpoints are the measures that answer the study question: • Primary endpoint — the main question (e.g. change in HbA1c at week 26). • Secondary endpoints — supporting questions (e.g. weight change, % reaching A1c < 7%). • Safety endpoints — adverse events, labs, vital signs, ECGs. • Exploratory endpoints. Data management prioritizes cleaning of data supporting primary and key secondary endpoints and safety ('critical data').

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