The Ebola Virus Disease (EVD) epidemic has highlighted the importance of being able to rapidly evaluate investigational products during a public health emergency, including in resource limited settings.
This workshop will explore the ethical and methodological assumptions behind the choice of different trial designs, describe different types of emerging infectious diseases of concern, and then explore several clinical trial designs for both vaccines and therapeutic products. Participants will discuss the scientific, ethical, and practical issues considered in the choice of specific trial designs, and the generalizability of these designs for other types of emerging infectious diseases.
This workshop is hosted by the Food and Drug Administration (FDA), in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) and the Centers for Disease Control and Prevention (CDC).
Final agenda (PDF, 330 KB)
More information including text agenda (click Agenda tab at top of page)
A webcast of the proceedings was available live on the NIH conference website during the event, and recorded for future viewing. Webcast recordings are linked below.
Day 1 webcast - November 9, 2015, 8:00 a.m. - 5:00 p.m. ET
Day 2 webcast - November 10, 2015, 8:00 a.m. - 5:00 p.m. ET - main conference, and first parallel session - Clinical Trial Designs for Preventive Interventions (Vaccines)
Day 2 webcast - November 10, 2015, 8:00 a.m. - 12:00 p.m. ET - parallel breakout session - Clinical Trial Designs for Therapeutic Interventions
Advance registration is now closed
Advance registration for on-site attendance closed on November 4, 2015. On-site registration will be available, if space permits. Registration is not required to view the webcast.
There is no fee to register for the workshop. Registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
Foreign attendees (non-U.S. citizens) are advised to register as soon as possible, for purposes of satisfying the NIH security clearance process. French translation is available for this workshop. You may indicate this need while completing the workshop registration.
Natcher Conference Center
National Institutes of Health (NIH)
Bethesda, MD 20894
Parking on the NIH Campus is very difficult as there limited visitor spaces. Attendees are strongly encourage to take public transportation. Additional information on traveling to NIH
Please allow a minimum of 30 minutes to be processed through security, register and find seating.
Meals and Refreshments
As this is a government workshop, no food or beverage will be offered in accordance with federal government mandates. The Natcher Building does have a cafeteria located on the first floor level, A Wing. Pre-ordered Boxed lunches that have been pre-paid will be available for pick up outside the meeting room. Order must be canceled at least 1 day prior to the meeting. Credit cards are charged after the event. Boxed Lunch details will be included in your conference confirmation email.
Food and Drug Administration
10903 New Hampshire Avenue, WO 31 Rm 5123
Silver Spring, MD 20993-0002
If you need special accommodations due to a disability, please contact Carrie Bryant (see Contact Person above) at least 7 days in advance of the workshop.
About the image above: NIH Clinical Center infectious disease nurse Lt. Michelle Holshue stands in front of the Ebola survivor's wall in Liberia. Lt. Holshue was deployed to Liberia to support clinical trials run by NIH/NIAID, and is a co-creator of the survivor's wall. (Image: NIH)