Selecting A Clinical Trial Design: How Broadly Should You Explore?

By Dr. Esha Senchaudhuri

When selecting clinical trial designs, how many design options should a sponsor explore? Would a sponsor feel more confident having an optimized design out of ten potential ones, or simulating several million designs to discover that there are three or four better options? Cytel’s experience suggests that this depends very much on the specific sponsor and the specific conditions of the clinical trial.

This only begs the question, what is a reasonable number of clinical trial designs to explore before feeling confident in a decision? Here are five considerations for sponsors when making this complex decision.