Enable Early decision-making with Early Endpoint Data - Example from A Complex Innovative Design of Systemic Lupus Erythematosus

Complex innovative designs (CID) with adaptive design features can potentially reduce cost, shorten cycle time and increase probability of success in drug development programs. Making Decisions using early data is critical in enabling features of adaptive design such as early futility and response adaptive randomization. In this presentation, a case study accepted by the FDA CID pilot program will be described and especially focusing on using early data for decision-making. Detailed simulation results will be presented to quantify the impact of this approach.

Bayesian

Longitudinal Data

Adaptive Design

Simulations

CID

Statistical Efficiency