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On July 25, 2022, FDA hosted a public meeting titled “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 was the second in a series of two public meetings. Speakers and participants discussed a range of issues related to 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: www.fda.gov/dr...
For more information, visit the meeting webpage: www.fda.gov/dr...