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  5. Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities -
  1. Advancing Regulatory Science

Workshop

Event Title
Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities

Collaborative Symposium hosted by Johns Hopkins University Center of Excellence in Regulatory Science and Innovation (JHU-CERSI) and The Food and Drug Administration

November 28, 2018
8:15 am-4:30 pm
(Registration begins at 7:30 am)

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.

Agenda

More information on the agenda is available at the JHU CERSI HTE Symposium Websitedisclaimer icon.

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

Registration

There will be no registration fee, but registration is required for FDA and non-FDA employees who want to attend in-person or access the workshop via the webcast.

Registration link to attend in-person or online (pre-registration is required):
https://collaboration.fda.gov/cersifdajhureg112818/event/registration.html

Remote Access Instructions/Webcast Registration (pre-registration is required):
To register for the webcast, please click the link above and then follow the instructions on the registration page. After you register you will receive a link via email as an outlook calendar invitation with information on how to access the live webinar. You must log in with your username and password which you create when you register. One must pre-register at least one day before the event to ensure that the access link emails and outlook invitations are received for each day.

Please provide the information requested for each attendee. Note: for those with Adobe Connect accounts, you will be asked for your password, or to create a new password.

For technical assistance please contact Jeffery Rexrode at Jeffery.Rexrode@fda.hhs.gov.

For Questions and Reasonable Accommodations:

For questions, please contact: FDA-JHUHTE_symposium@fda.hhs.gov.

Recording Disclosure

This event will be recorded and made available to the public after its conclusion. Any information shared publicly by participants in the audience during the event will become part of that recording. This includes the verbal question and answer sessions.

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