A1079
Title: Complex innovative design pilot program and a potential proposal
Authors: Li Wang - AbbVie (United States) [presenting]
Abstract: The complex, innovative design (CID) pilot program from FDA provided an excellent opportunity for industry statisticians to think out of the box and to push the boundary on trial designs for late-stage studies. A potential Bayesian CID in SLE is proposed to combine Bayesian dose-ranging, master protocol, sequential group design and short-term/long-term biomarkers together to speed up clinical development and increase the probability of success for the platform. Design parameters, including the maximum sample size, are calibrated to obtain good frequentist properties such as type I error and power. A hypothetical trial of three agents for systemic lupus erythematosus is used to illustrate the concept, and extensive simulations show that the proposed design compares favourably to several conventional platform designs.
