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
Slide 1 / 5Endpoints 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').