Advanced Design Framework: Part 1 – Methods For Thorough Exploration Of Design Space

Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought-leaders after a decade of fine-tuning clinical development processes. The framework consists of three parts: Thoroughly Explore, Decide Together, and Communicate Trade-Offs.

The Framework demonstrates how to unify statistics and strategy in the era of cloud-computing, by making strategic use of well-resourced statisticians. This week, we take a deeper look into the first part of this Framework, revealing how to explore hundreds of thousands of designs available to sponsors, rapidly and in real-time, to improve the chances of identifying the design that optimizes for speed, success, and savings.

When designing clinical trials for optimal development productivity, conventional wisdom has been to explore as many designs as possible before optimizing across reasonable parameters like development timelines or expected probability of success. However, time and design tool limitations have restricted the breadth of exploration possible, so it has been necessary to carefully select the portion of the design space to examine for consideration. The introduction of complex innovative designs and advanced designs like sample size re-estimation, endpoint adaptation and other novel methodologies has made the need for prospective planning even more significant.