Date post: | 04-Jan-2016 |
Category: |
Documents |
Upload: | sydney-newton |
View: | 216 times |
Download: | 0 times |
Bench to patient in record time;Conducting trials in the Ebola
outbreak
Professor Trudie Lang, University of Oxford
Rapide BCV Trial Key Milestones Grant awarded to study start = 4months
Grant awarded DM system Protocol Drug Selected Contracts Ethics -- Oxford Ethics - Liberia Import license Export drug Final agreements First Patient
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1Sept Oct Nov Dec Jan
The Epidemic and research
Monthly new cases
March 14 Jan 15
Grant awarded First patient
Sept 14
Lost 6 weeks
Nov - Dect14
Total
cases
21,000
Total
cases
21,000
Clinical research responses to ID outbreaks are usually fragmented and too late
time
Public Health Response
Preclinical Research Response
Clinical Research Response
What is Bill Gates Afraid Of?"I rate the chance of a nuclear war within my lifetime as
being fairly low," says Gates. "I rate the chance of a widespread epidemic, far worse than Ebola, in my lifetime,
as well over 50%.”
Outbreak Mode
Inter-Epidemic Mode
Outbreak Mode Committee (OMC):Standing committee that convenes when the Coordinator is contacted in relation to a new specific ID outbreak to discuss the appropriate Outbreak Mode (1, 2 or 3)Composition: Herman Goossens (Chair), Menno de Jong, Marion Koopmans, Peter Horby
Outbreak Research Preparation Mode
Outbreak Research Team (OTC)Ad-hoc PREPARE expert committee
1
Outbreak Research Mobilisation Mode2
Outbreak Research Team (ORT):•PREPARE Executive Board;•ad-hoc PREPARE experts;
Planning and implementation of preparatory work necessary to achieve operational readiness to initiate clinical research response to specific ID outbreak if and when needed.
Outbreak Research Response Mode3
Outbreak Research Team (ORT):•PREPARE Executive Board;•ad-hoc PREPARE experts;•Ad-hoc external experts if necessary;
Planning and implementation of clinical research response to specific ID outbreak, building on the generic clinical research activities and preparedness activities in PREPARE.
Outbreak Research Plan: Outbreak Research Plan:
GA decision, EC (tacit) approval
GA decision, EC (tacit) approval
GA decision, EC (tacit) approval
GA decision, EC (tacit) approval
GA decision, EC (tacit) approval* * *
*
*
0** *
Assessing operational readiness in the network and development of clinical protocol if needed