The principle of patient-centricity has been widely accepted by health research community and legislators. As empowered patient groups begin to seek playing a bigger role in medical product development process, the FDA has committed to explore new methods to engage patients in a systematic and scientific manner. For example, last year the FDA Center for Devices and Radiological Health released a final guidance document on patient preference information. This presentation will describe a regulatory landscape of emerging science of patient input on various fronts and will discuss how patients’ values can help statisticians see clinical trials in a new light.
Bio: Mr. Martin Ho is the Associate Director for Quantitative Innovations at the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health (CDRH) of the FDA. He has led CDRH’s Quantitative Innovation Program (QuIP) to promote and facilitate using novel quantitative methods to inform regulatory decision making at CDRH. The QuIP develops good review practices for innovative regulatory tools (such as patient preferences, patient-reported outcome, and systematic benefit-risk assessments), assimilates these new tools into regular review processes, and builds review capacity to meet CDRH’s intermediate and long-term needs. The QuIP also provides technical leadership in pilot projects to explore new regulatory methods funded by CDRH. Mr. Ho is the Past President of the FDA Statistical Association. He is the voting representative of CDRH in the FDA Research Involved Human Subject Committee, the FDA’s IRB. He was a statistical reviewer, team leader, and acting branch chief reviewing medical device submissions of various therapeutic areas. Prior to joining the FDA in 2009, he was a senior statistician in various contract research organizations planning and conducting clinical studies for 10 years.