Adaptive Clinical Trial Success Via A Unified Data Management And Acquisition Platform

By Danya Potgieter and Lizette Kilian, MMS Holdings; and Walker Bradham, Merative

Adaptive trials — clinical trials whose design allows for planned modifications to one or more trial aspects based on accumulated data — can seem dauntingly complex. However, a more complete understanding of adaptive trials’ advantages, combined with a strong partnership between a sponsor, a CRO and its technology partner(s), can simplify such trials and enable more organizations to reap their benefits.

First, one must explore the challenges inherent in delivering a complex adaptive trial design in the real world, followed by study of successful methods associated with adaptive trials. The TOGETHER trial — a project executed by MMS Holdings utilizing the Zelta clinical trials platform by Merative — discussed below provides a relevant example. MMS is a data-focused CRO, while Merative is a spinoff of IBM Watson Health that offers the Zelta clinical data management and acquisition platform (formerly known as Merative Clinical Development). This single instance, single-code-based system does not require any integration, so MMS and other CROs can design their trials by picking and choosing only aspects of the product they need for a given trial.