The PhRMA working group has defined an adaptive design as a “multistage study that uses accumulating data to decide how to modify aspects of the study without undermining the validity and integrity of the trial”. The adaptations include early works in this area, such as two-stage design, group sequential design or sample-size re-estimation design, as well as new methods like adaptive dose-finding design, play-the-winner design or treatment-switching design. Adaptive seamless designs, combining two traditional trials in different phases into a single trial, reduce cost and time to market.

From a regulatory standpoint, adaptive designs are receiving ever increasing acceptance. In Europe, a new reflection paper on flexible or adaptive design was published in September 2007.

Operationally, an adaptive design very often requires real-time data collection and analysis. In this regard, cIinIT offers the entire backbone for your adaptive design trial through implementation of data standardizations such as CDISC, central randomization via IVR/IWR system and EDC.