Transcript Trudie Lang - University of Oxford

Bench to patient in record time;
Conducting trials in the Ebola
outbreak
Professor Trudie Lang, University of Oxford
Rapid research response
Rapide Platform Target Product Profile
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
Sept
2
3
4
1
Oct
2
3
4
1
Nov
2
3
4
1
Dec
2
3
4
1
Jan
The Epidemic and research
Monthly
new
cases
March 14
Grant awarded
Sept 14
Nov - Dect14
Lost 6 weeks
Jan 15
First patient
Clinical research responses to ID outbreaks
are usually fragmented and too late
time
Clinical Research Response
Preclinical Research Response
Public Health 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
GA decision, EC (tacit) approval
GA decision, EC (tacit) approval
2
*
Outbreak Research
Mobilisation Mode
Preparation Mode
Outbreak Research Team
(OTC)
Ad-hoc PREPARE expert
committee
Assessing operational readiness in
the network and development of
clinical protocol if needed
*
0
GA decision, EC
(tacit) approval
Inter-Epidemic
Mode
*
Outbreak Research Team
(ORT):
• PREPARE Executive
Board;
• ad-hoc PREPARE experts;
• Ad-hoc external experts if
necessary;
Outbreak Research Team
(ORT):
• PREPARE Executive Board;
• ad-hoc PREPARE experts;
* Outbreak Research
1
3
Outbreak Research
Response Mode
Outbreak Research Plan:
Outbreak Research Plan:
Planning
and
implementation
of
preparatory work necessary to achieve
operational readiness to initiate clinical
research response to specific ID outbreak
if and when needed.
Planning and implementation of clinical
research response to specific ID outbreak,
building on the generic clinical research
activities and preparedness activities in
PREPARE.
*
GA decision, EC (tacit)
approval
*
*
GA decision, EC
(tacit) approval
*
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