Logistics of Implementing Adaptive Trial Designs and Adaptive Randomizations
*Eva Miller, Almac Group 


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. A form of adaptive trial design involving the allocation rule (covariate baseline adaptive randomization, response adaptive randomization or hybrids involving both covariate baseline and response adaptive randomization) requires planning, simulations, and