Check out the webinar series from MDIC!
MDIC presents an informative series of online teleconference workshops featuring emerging trends in medical technology regulatory science, MDIC projects and subject matter experts sharing perspectives, progress and opportunities.
The last webinar was focused on using patient preference for setting alpha and beta error levels in clinical trials.
November 17, 2017 – Patient values and P-Values: Exploring a new method for developing patient-centered clinical trials
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.
More about MDIC
MDIC is the only public-private partnership (PPP) focused exclusively on the strategic needs of the medical device ecosystem. MDIC is designed to create a collaborative environment where the industry, nonprofit organizations, and government can work together to advance pre-competitive medical device research so that the medical device community can keep pace with the needs of patients in the United States in a more timely manner.