Emergency Preparedness and Response

Public Workshop - Clinical Trial Designs for Emerging Infectious Diseases

Info | Agenda | Transcripts | Webcast Recordings | Contact

FDA is establishing a public docket to receive input on clinical trial designs in emerging infectious diseases. Interested parties are invited to submit comments, supported by research and data, regarding clinical trial designs. Submit comments on the collection of information by January 28, 2016.

NIH Clinical Center infectious disease nurse Lt. Michelle Holshue stands in front of the Ebola survivor wall in Liberia. Lt. Holshue was deployed to Liberia to support clinical trials run by NIH/NIAID (image: NIH)November 9-10, 2015
8:00 a.m. - 5:30 p.m.
Bethesda, Maryland and webcast

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). 

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Agenda

Final agenda (PDF, 330 KB)

 

More information disclaimer icon including text agenda (click Agenda tab at top of page)

Transcripts and Videos

View transcripts and videos from this workshop

Webcast

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

Registration

Advance registration is now closed 

Advance registration disclaimer icon 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.

Location

Natcher Conference Center
Building 45
National Institutes of Health (NIH)
Bethesda, MD  20894

Logistics

Lodging information disclaimer icon

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 disclaimer icon

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.

Contact Person

Carrie Bryant
Food and Drug Administration
10903 New Hampshire Avenue, WO 31 Rm 5123
Silver Spring, MD 20993-0002
Tel. 301-796-8215
FAX: 301-847-2512
Email: carrie.bryant@fda.hhs.gov

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)

 

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