U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. News & Events for Human Drugs
  4. Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Lessons Learned about Data Collection and Analysis - 07/25/2022
  1. News & Events for Human Drugs

Virtual | Virtual

Event Title
Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Lessons Learned about Data Collection and Analysis
July 25, 2022


Date:
July 25, 2022

This meeting is the second in a series of two public meetings:

Meeting #1: June 30th: 11am-1pm

Meeting #2: July 25th: 11am-1pm

The Food and Drug Administration (FDA) is announcing a series of two public meetings entitled

  1. Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Who to Ask and How to Ask
  2. Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Lessons Learned about Data Collection and Analysis

This meeting page is for Meeting #2.

 

Meeting Materials

Topics for Discussion at Meeting #2 (July 25, 2022)

Speakers and participants will discuss a range of issues data collection and analysis, focusing on lessons learned and on areas identified as particularly challenging for stakeholders. You may find a link to the referenced guidance documents here: PFDD Methodologic Guidance Documents

This website will be updated as meeting materials are developed.

Registration: To register for this meeting, visit: https://www.eventbrite.com/e/patient-experience-data-in-clinical-trials-lessons-learned-tickets-363026190107

Public Docket: Interested stakeholders are invited to share examples of how they have used the PFDD Methodologic Guidance Series to advance the inclusion of the patient voice in the drug development process to the public docket. The public docket will close on September 23, 2022.

Related Information:


 
Back to Top