Program

In-person AND virtual! – We are pioneering a new conference format that will connect in-person and virtual audiences to create a unique experience. Matching the innovation that comes through our members’ work, ISPOR is pushing the boundaries of innovation to design an event that works in today’s quickly changing environment. 

In-person registration included the full virtual experience, and virtual-only attendees will be able to tune into live in-person sessions and/or watch captured in-person sessions on-demand in addition to having a variety of virtual-only sessions to attend.

Approaches for Utilizing Patient Preference Information to Inform Clinical Trial Design

Speaker(s)

Barry Liden, Juris Doctor (JD), Patient Engagement, Edwards Lifesciences, Garrett Park, MD, USA, Shelby Reed, PhD, RPh, Preference Evaluation Research (PrefER) Group, Duke Clinical Research Institute, Durham, NC, USA and Michelle Tarver, MD, PhD, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA

Presentation Documents

The objectives are to introduce a heart failure patient preference study; to introduce approaches for utilizing patient preference data to inform clinical trial designs; and to discuss FDA’s perspectives on these topics.

Patient preference information (PPI) studies offer the opportunity for medical device sponsors, regulators, and other stakeholders to quantify what matters most to patients. Taking full advantage of this opportunity requires a series of thoughtful decisions in designing a patient preference study and subsequent use of PPI in clinical trial designs. The Medical Device Innovation Consortium undertook a series of case studies and activities, including measuring patient preferences in heart failure and interviews with experts across the medical device ecosystem, to identify lessons learned and approaches for utilizing PPI to inform clinical trial designs.

The session will begin with an overview of MDIC, development of the Patient Preference Information in the Design of Clinical Trials Framework, and how lessons learned and approaches were developed (5 min, Liden). This will be followed by a summary of one of MDIC’s PPI case studies that involved six medical device companies and was focused on developing and conducting a study to understand patient preferences pertaining to heart failure devices (10 min, Reed). The session will continue with an overview of approaches for incorporating PPI in clinical trial design, including opportunities to engage with regulators, experts and patients, identifying relevant endpoints, appropriate ways to leverage PPI for use in statistical evaluations of trial data, and generalizability of the PPI study sample to the population of patients eligible for a device (20 min, Liden). In the final presentation, FDA-CDRH will provide perspectives on use of PPI (10 min, Tarver). The session will conclude with a discussion between audience and speakers (15 min). This session may benefit clinical trialists, medical device and pharmaceutical sponsors, and regulators.

Code

300

Topic

Patient-Centered Research