Background: Longitudinal exposure-response (E-R) modeling of clinical endpoints is important in drug development to identify optimal dose regimens. Clinical endpoints are often ordinal composite scores. Typically, endpoints with few (e.g., <6) categories are analyzed as categorical, and endpoints with many (≥10) categories are analyzed as continuous. Endpoints with many categories often show skewed distributions that […]
Author: Chuanpu Hu
When Missing Does Not Mean Lost [OED]
Background: Missing data due to subject dropout from study is common in late phase clinical trials. It is possible for missing to be equivalent to lost and has no relevance to time course of the data. On the other hand, circumstances exist where compelling reasons could be formed to argue that dropout is related to underlying […]