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Incorporating Patient Preferences into Regulatory Decision Making
Friday, December 1, 2017
11:00 a.m. - 1:00 p.m. EST
Must register before November 30
Presenter:
Dr. Telba Irony
Center for Biologics Evaluation and Research
FDA
Regulatory authorities and patient advocacy groups have been paving the way towards engaging patients in medical product development and regulatory review. These efforts gave rise and relevance to the development of the Science of Patient Input, or SPI. SPI consists of scientifically valid qualitative and quantitative methods for capturing patient perspective information to incorporate it into product development and regulatory decision making. Two types of patient input, Patient Reported Outcomes (PRO) and Patient Preference Information (PPI) are expected to be captured in accordance with applicable scientific and statistical standards and best practices, and statisticians have a large role to play.
A PRO is a measurement based on a report of a patient's health status that comes directly from the patient, without interpretation of the patient's report by a clinician or anyone else. Some symptoms or other unobservable concepts known only to the patient, such as pain or fatigue, can only be measured by PRO measures.
PPI is a patient's expression of desirability or value of one course of action or selection in contrast to others. It focuses on assessing the importance, or preferences, that patients place on the benefits, harms and other aspects of treatments.
In this Webinar we will introduce key elements concerning elicitation and use of patient preferences (PPI) to inform regulatory decision making. As an example, we will present a study commissioned by the FDA to elicit obese patients' preferences in choosing weight-loss devices and show how these preferences can be used to inform regulatory decision making. We will describe the weight-loss device survey and present the survey results, which have been used to develop a decision-aid tool for regulatory reviewers. The tool provides estimates of patients' benefit-risk tradeoff preferences and also stratifies patients according to their risk-tolerance. We will conclude the Webinar by sharing experiences in using patient preferences in the regulatory process and talking about best statistical practices for eliciting and using patient preference information.
Register on the ENAR Website
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