A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology
Patient Introduction
The Patient Centered Benefit-Risk (PCBR) Framework introduces the concept of the total product development lifecycle and discusses how patient preference information might be useful at each stage of this lifecycle. The report provides background on the concepts of benefit-risk and patient preference and discusses when in the product lifecycle such information might be collected. The PCBR Framework is intended to improve the understanding of the medical device community of how the patient’s perspective can be incorporated into the regulatory approval process. This framework is of interest to patients as an overview of the medical device product development process and the opportunities proposed for patient preference engagement.
Summary
The PCBR Framework is intended to improve the understanding of the medical device community of how the patient’s perspective might be incorporated into the regulatory approval process. This framework provides background on the concepts of benefit-risk and patient preference, discusses the potential value of including benefit-risk in a regulatory submission, discusses when in the product lifecycle such information might be collected, outlines factors to consider when selecting a patient preference method, and discusses considerations regarding the use of patient preference information in the regulatory process, reimbursement, marketing, and shared medical decision making.
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TOTAL PRODUCT LIFE CYCLE
Discovery and Ideation, pg. 42
Invention and Prototyping, pg. 43
Pre-clinical, pg. 43
Clinical, pg. 43
Exhibit 4-1: Patient Preference Information and the Product Development Lifecycle, pg. 42
Exhibit 4-2: Opportunities for Collection and Use of Patient Preference Information during the Product Development Lifecycle, pg. 45
SPI GUIDING PRINCIPLES
Section II: Patient Centered Benefit-Risk Assessment: Definitions and Background Concepts, pg. 19
Section IV: Potential Use and Value of Patient Preference Information in the Product Development Lifecycle, pg. 42
Section V: Factors to Consider in Undertaking a Patient Preference Study, pg. 49
Section VIII: Future Work in the Collection and Use of Patient Preference Information for Regulatory Purposes, pg. 78
Appendix A: A Catalog of Methods for Assessing Patient Preferences for Benefits and Harms of Medical Technologies, pg. 90
REGULATORY DECISION
Executive Summary pg. 4
Section I: Introduction to the MDIC Patient Centered Benefit-Risk Project Framework Report, pg. 8
Section II: Patient Centered Benefit-Risk Assessment: Definitions and Background Concepts, pg. 25
Section III: Evaluating the Potential Value of Patient Preference Information in Regulatory Benefit-Risk Assessments of Medical Technology, pg. 31
Section IV: Potential Use and Value of Patient Preference Information in the Product Development Lifecycle, pg. 40
Section VI: Considerations in Using Patient Preference Information in the Regulatory Process, pg. 61
Section VIII: Future Work in the Collection and Use of Patient Preference Information for Regulatory Purposes, pg. 84