Sponsor Discovers Unique Study Design That De-Risks Clinical Trial And Optimizes Commercial Strategy

Da Volterra wanted to maximize the power of their clinical trial for scenarios with a smaller treatment effect, and were contemplating a Sample Size Re-estimation design.

Unfortunately, with a strict enrollment limit of 1,100 patients, this particular study design produced only marginal gains in power over the fixed sample size design.

The Sponsor’s Chief Medical Officer was not content to risk the success of their new drug on a suboptimal trial design.

By working with Cytel’s statistical consultants and their powerful new software platform Solara, Da Volterra was able to maximize the chance of a successful trial result with precise insight into the tradeoffs in speed, savings and success with a simple, low-risk trial design identified within hours.