Collection
Patient Preferences to Inform Decision Making in Medical Product Development
Therapeutic Innovation and Regulatory Science (TIRS) is calling for papers for a special collection entitled Patient Preferences to Inform Decision Making in Medical Product Development.
The number of patient preference studies related to treatment choice has increased substantially in recent years. Many of these studies focus on eliciting patients’ preferences for attributes of treatments that have recently received or soon will be considered for marketing authorization by regulators. Applications of preference methods to the myriad decisions that sponsors encounter earlier in clinical development have been fewer in number.
This special collection will focus on applications of patient preference methods to elicit patient input to inform clinical development decisions. Such decisions include, but are not limited to: endpoint identification and selection, clinical trial design, clinically meaningful changes in outcomes, target product profiles, and weighting for composite endpoints and preference-weighted PROs.
Papers will be considered if they address explicitly decisions that sponsors, regulators, and other decision makers need to make prior to an application for market authorization. Although theoretical and methods papers will be considered, preference will be given to empirical applications.
For questions regarding suitable content, submission status, and guidelines, please email Dr. Sandra Blumenrath, Managing Editor of TIRS, at Sandra.Blumenrath@diaglobal.org.
Editors
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Brett Hauber
Brett Hauber, PhD, is Senior Director, Patient Preferences in Worldwide Medical and Safety at Pfizer. He is also Affiliate Associate Professor in the Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute at the University of Washington School of Pharmacy. Dr. Hauber has 20+ years of experience in stated-preference research and is active in IMI-PREFER. He was the PI on the Catalogue of Patient Preference Methods developed by the Medical Device Innovation Consortium, a member of multiple ISPOR Task Forces, and Chair of the ISPOR Task Force for Good Research Practices for the Statistical Analysis of Discrete-Choice Experiments.
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Shelby D. Reed
Shelby D. Reed, PhD, is Professor in the Departments of Population Health Sciences and Medicine at Duke University’s School of Medicine. She is the director of the Center for Informing Health Decisions and Therapeutic Area leader for Population Health Sciences at the Duke Clinical Research Institute (DCRI). She also is core faculty at the Duke-Margolis Center for Health Policy. Dr. Reed has over 20 years of experience leading multidisciplinary health outcomes research studies. She has extensive expertise in designing and conducting trial-based and model-based cost-effectiveness analyses of diagnostics, drugs and patient-centered interventions
