Using patient preference information to set the significance level and power of a clinical trial can maximize the value of a clinical trial based on the relative importance of benefit and risk outcomes to a specific patient population. The explicit incorporation of patient preferences into clinical trial design will address the longstanding conundrum that, in an enterprise devoted to easing the burden of disease, the afflicted currently have no input into the process. By designing clinical trials that reflect patients’ urgency and risk tolerance, scarce resources can be allocated more efficiently, bringing more therapies to more patients faster and more efficiently.
The webinar speakers recently published an article on using the CDRH obesity patient preference study to set the statistical design for a hypothetical clinical trial. This retrospective analysis informs the ongoing MDIC project to use patient preferences to inform the design of Parkinson’s Disease clinical trials.