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This meeting is the first 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 #1.

Meeting Agenda (PDF – 157 KB)

Topics for Discussion at Meeting #1 (June 30, 2022)

Speakers and participants will discuss a range of issues and best practices related to collecting patient input, selecting data collection methods, and developing sampling plans and strategies. External stakeholders will present examples of how they have used the guidance documents as tool to inform their collection of patient data. You may find a link to the referenced guidance documents here: PFDD Methodologic Guidance Documents

Meeting #2:

Information on Meeting #2 can be found at the following site: 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 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-who-to-ask-and-how-to-ask-tickets-

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:

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