Abstract

Objectives: In addition to the values of efficacy and safety endpoints, the timing of such endpoints relative to the start of treatment is often of interest. A commonly used statistical methodology for analyzing such time-to-event data is survival analysis (SA). Building upon the implementation of CDISC standards in data collection facilitating the standard format of clinical trial data and previous systemization efforts, 1, the objective of this work was to develop a system to standardize analysis dataset creation, exploratory data review, and SA procedures for exposure-response (E-R) analyses of time-to-event endpoint data.

Eighth American Conference on Pharmacometrics (ACoP) Annual Meeting: October 15-18, 2017, Fort Lauderdale, FL

By Julie Passarell, Caroline Passarell, Jill Fiedler-Kelly