Adaptive clinical trials offer many potential benefits, improving therapy development efficiency while reducing time and cost.
The unique operational demands of adaptive trials, however, involve greater complexity, speed and blinding requirements than existing trial infrastructure can support. Furthermore, attempts to augment existing trial infrastructure with manual processes that support adaptive decision-making, such as changes to randomization or drug supplies, can still undermine trial integrity and may not meet regulators’ expectations.
An adaptive execution environment, based on integrated technology platforms and automated processes, can make adaptive clinical trials both practical and profitable throughout the product development cycle.
Examine the features and advantages of an integrated adaptive trial execution environment. We also review two seamless adaptive trial designs, the operational risks these designs present, and how FLEX ADVANTAGE addresses these challenges to ensure sponsors can reap the rewards of the adaptive design as intended.