RL06 Logistics of Implementing Adaptive Trial Designs
*Eva Miller, ALMAC Clinical Technologies 


Logistical considerations for adaptive trial implementation are more involved requiring more planning, constant communication and greater teamwork than traditional ones. Adaptive studies also require automated systems with inherent flexibility, speed, accuracy, timely results reporting and automated drug supply management. These logistical and operational considerations in implementing adaptive designs have recently drawn greater attention because the infrastructure for managing the traditional double-blind, randomized, parallel group clinical trial does not lend itself to the challenges presented in implementation of flexible designs. We will also look at various forms of adaptive trial designs and discuss case studies of the logistical implications for teams and automated systems for implementing these trials successfully.