ADaM Dataset Structure Explained
A practical guide to ADaM dataset structure for clinical programmers, including ADSL, BDS, OCCDS, variables, parameters, baseline, analysis values, derivations, traceability, and SAS implementation.
ADSL: The Subject-Level Analysis Dataset
A practical guide to ADSL, the ADaM Subject-Level Analysis Dataset, including subject-level variables, treatment, analysis populations, dates, baseline concepts, disposition, exposure, safety, efficacy, derivations, traceability, and SAS and R implementation.
3+3 Design Explained
A comprehensive guide to the traditional 3+3 dose-escalation design for Phase I clinical trials, including dose cohorts, dose-limiting toxicities, escalation rules, expansion to six patients, MTD determination, worked examples, operating characteristics, limitations, and alternatives.