CDER Patient-Focused Drug Development Upcoming Public Meetings The Food and Drug Administration (FDA) is announcing a series of two public meetings entitled - 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
- 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
Meeting #1: June 30th: 11am-1pm Meeting #2: July 25th: 11am-1pm 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 This meeting is the first in a series of two public meetings. 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 For more information, and to register for Meeting #1, please click here. 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 is the second in a series of two public meetings. 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 For more information, and to register for Meeting #2, please click here. |
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