TL01: Multi-Arm Multi-Stage (MAMS) Designs in Clinical Drug Development
*Cyrus Mehta, Cytel Inc. 

Keywords: multiple comparisons, group sequential, master protocols, drop the loser,multi-arm versus two-arm

MAMS designs are a generalization of classical two-arm group sequential designs that involve multiple treatment arms being compared to a common control. In these designs one can drop "losers", select "winners", and re-estimate the sample size at one or more interim analysis time-points. Stopping boundaries that achieve strong control of type-1 error are obtained through error spending functions and may be re-computed if there is a adaptive design change. In this round table luncheon we will discuss the applicability of MAMS designs for trials by individual sponsors as well as for Master Protocols in which each sponsor contributes a treatment arm. Efficiency comparisons relative to two-arm group sequential designs will also be discussed.