About the Symposium:

Heterogeneity of treatment effects (HTE) is the variation in how individuals respond to a treatment. This is a vital and yet underexplored concept of importance to regulators, manufacturers, payors, healthcare providers, academic researchers, and patient and consumer advocacy groups. HTE is of high relevance to the FDA for product approval, labelling, and post-marketing surveillance. We propose a stimulating symposium comprised of talks and panel discussions by leading experts that engages various stakeholders in how to assess and communicate HTE. 

The symposium will focus on the following topics: 
•	Major sources of HTE including subpopulations (e.g., sex, race, pediatric and geriatric populations)
•	HTE considerations in study design and statistical analysis
•	How HTE may be communicated to stakeholders via various avenues such as drug trial snapshots and labeling.

Who Should Attend?

This workshop is open to the public.  The intended audience includes government, academia, industry, healthcare providers, payors, patients, and patient and consumer advocacy groups.

Location and Logistics:

The Food and Drug Administration
10903 New Hampshire Avenue
The Great Room (1503 B & C)
Silver Spring, MD 20993.  

Directions, Parking and Accommodation Information:
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm

Information on the event and speakers can be found here:
https://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm611410.htm and here https://www.jhsph.edu/research/centers-and-institutes/center-of-excellence-in-regulatory-science-and-innovation/news-and-events/Critical-Issues-in-Heterogeneity-of-Treatment-Effect.html
 
For questions, please contact: FDA-JHUHTE_symposium@fda.hhs.gov