U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Science & Research
  3. Science and Research Special Topics
  4. Advancing Regulatory Science
  5. Characterizing Benefit-Risk Tradeoffs in Opioid-Based Chronic Pain Treatment
  1. Advancing Regulatory Science

Characterizing Benefit-Risk Tradeoffs in Opioid-Based Chronic Pain Treatment

CERSI Collaborators: Stanford University: Sean Mackey, MD, PhD; Corinne Jung, PhD; Kate Lorig, PhD

FDA Collaborators: Center for Devices and Radiological Health: Michelle Tarver, MD, PhD; Anindita Saha; David Gebben, PhD; Allen Chiu, MD; Formerly of Center for Devices and Radiological Health: Allen Chen, PhD; Fraser Bocell, MD

CERSI Subcontractors: University of Houston: Partha Krishnamurthy, PhD, MBA; Ye Hu, PhD; Northwestern University: Karon Frances Cook

Project Start Date: December 1, 2019

Regulatory Science Challenge

New devices authorized by the FDA to manage pain and treat opioid-use disorder (OUD) to either reduce pain, or use of opioids, in patients, should demonstrate that the probable benefits of the device outweigh its probable risks. It is helpful to have a measurement to assess a minimally acceptable level of device benefit at reducing pain when choosing to decrease the use of opioid medications. However, no such metric currently exists. Therefore, the purpose of this project is to quantify the minimum acceptable benefit of reducing prescription opiates for pain management for patients with chronic pain.

Project Description and Goals

The goal of this project is to help patients, clinicians, and regulators (1) understand how patients assess the risk to benefit tradeoff in making the best choices for opioid use in chronic pain management and (2) develop metrics to quantify minimal acceptable benefit.

This project will collect research data in two-steps:

Step 1: Interview a small focus group of patients who are currently taking prescription opioids about what factors they consider when making decisions about their chronic pain management. Investigators will then analyze the interviews to develop a list of top attributes to consider in prescription opioid use.

Step 2: Use the top factors or attributes identified above by patients to develop and nationally implement a Discrete Choice Experiment (DCE), a type of survey that gives participants scenarios where they must assess different options and make selections that may require tradeoffs. This allows researchers to identify and quantify patient preferences.

Back to Top