Controlled Studies

Summary

Establishes randomized controlled trials as the first experimental design in the sequence, building exchangeability through random allocation and walking through ICMJE trial registration, the WHO ICTRP, and the CONSORT 25-item reporting checklist. Maps the four phases of clinical research from first-in-human Phase 0 through post-marketing Phase 4, illustrated by Andriole's PSA-screening trial. Covers comparator choice including placebos and non-inferiority designs with their delta margins, eligibility criteria trade-offs, intervention specification with the Groeneveld creatine-ALS trial as a masking example, and six allocation methods including simple, block, stratified, and adaptive randomization.