Learn Analysis Data Model (ADaM)

Basics

Phases

1. Phase 1: safety; sample size is ~10-20
2. Phase 2: dose finding
3. Phase 3: efficacy

Estimand

The main goal of the Estimand framework is to formalize a question of interest that the study aims to answer

1. Treatment
2. Population
3. Variable of interest
4. Population level summary measure
5. Handling of intercurrent event

Clinical data flow

1. Raw data collected through CRF/Non-CRF
2. Standardize data into SDTM
3. Transfer data to analysis ready format ADaM
4. Summarize data using TLGs
5. Deliver results