European & Developing Countries
Clinical Trials Partnership (EDCTP)
Towards EDCTP2
22 July 2014
Melbourne, Australia
Ole F. Olesen, Ph.D., HD
Director of North-North Cooperation,
EDCTP, The Netherlands
Justification for EDCTP2
Objectives
•
Clinical development of effective, safe, accessible, suitable and
affordable medical interventions for poverty related and neglected
diseases (PRNID) in partnership with sub-Saharan African countries
Problem
• No economic incentive for private investments in PRNID
• Public investments are sparse and fragmented
• Know-how is fragmented
Background
• EDCTP-1: 2003-2015
• EDCTP-2: 2014-2024
Who we are
Participating States
13 European Countries
Austria, Denmark, Finland, France, Germany,
Ireland, Italy, Luxembourg, Netherlands,
Norway, Portugal, Spain and United Kingdom
9 African Countries
Cameroon, Congo, Ghana, Mozambique,
Senegal, South Africa, Tanzania,
Uganda, Zambia
Countries that can receive funding
• All sub-Saharan African countries
• All EU Member States and Associated Countries
Governance
General Assembly
(1 Member from each
Participating State)
advice
Scientific Advisory
Committee
(SAC, 16 Members)
• Public-Public Partnership between
sovereign states
Board
(5 Members)
• Operates as an independent legal entity
• Owned by the Participating States
EDCTP Secretariat
(Hague, NL + Cape Town, ZA)
• “Membership fee” of 200,000 EUR/year
How it operates
Industry, other
funders, NGO’s,
like-minded
organisations,
>683 M €
683 M €
Capacity for
Clinical Trials in
Africa
>500 M €
Clinical Trials in
Africa on PRNID
What we do
Diseases: HIV/AIDS, TB, Malaria and NIDs
New tools and interventions: Diagnostics, drugs, vaccines and
microbicides
Capacity Development: Fellowships, Networks, Ethics, Regulatory
EDCTP in a nutshell
Number of projects - 246
• 259 institutions participate
and receiving funds from
EDCTP
• 3442 posts are supported on
EDCTP grants
Clinical trials - 100
Training of scientists - 514
Publications - 485
Funding for HIV:
2003-2013
Clinical trial
(€ ‘000)
Non trial
(€ ‘000)
Diagnostics
-
€ 291
Microbicides
€ 2,455
€ 6,932
Treatment*
€ 28,880
€ 419
Vaccines
€ 12,753
€ 10,633
Other**
-
€ 4,051
Total
€ 44,088
€ 22,326
*Including € 5.85 million of funding to support
projects on prevention of mother-to-child
transmission
**Including immunology, epidemiology and crosscutting issues.
Clinical trial
Non-clinical trial
HIV/AIDS activities
54 research projects
in 23 sub-Saharan
Africa countries
Highlights of selected
projects
• CHAPAS-1: contributed to the evidence base that led to FDA approval and
WHO prequalification of PEDIMUNE, a fixed-dose combination formulation
for the treatment of HIV in children
• CHAPAS-3: evaluates three fixed-dose combination first-line antiretroviral
drugs
• Kesho Bora: Influenced revision of 2010 WHO guidelines on PMTCT: 43%
reduction in HIV infections in infants and >50% reduction of PMTCT
• PROMISE-PEP: Prevention of mother to child transmission of HIV1 during
12 months of breastfeeding
• TaMoVac: Demonstrated that the prime/boost HIV-1 DNA
multigene/multiclade-MVA/CMDR vaccine is safe and highly immunogenic
when administered intradermally
• HIV-TB Pharmagene: demonstrated that there is no need to increase
efavirenz dose during concomitant rifampicin based anti-TB therapy
• PRO2000: showed the microbicide was safe (but not efficacious)
How does it work?
Annual Work Plan with call topics
Thematic Stakeholder meetings (5 in 2013); Scientific
advisory Committee; Commissioned studies, other input
First EDCTP2 work plan in August 2014 (tbc)
Calls for proposals for Integrated Projects
(Selected, funded and managed by EDCTP Secretariat)
National calls for proposals
(Selected, funded and managed by PSs according to
national rules)
Integrated Activities
Consortia of 2 European PS and 1 subSaharan African country (minimum)
1. Clinical Trials
(collaborative research)
Either full funding (100% of costs) or cofunding (up to 33%) with other funders
Broad non-prescriptive topics, bottom-up
2. Fellowships
Grants to individuals: Career development,
Senior, Industry, Regulatory, other
100% funding
3. Capacity Support
Individual institutions or consortia for ethics,
training, networking and regulatory activities
100% funding
Thank you
www.edctp.org
The power of sharing science
Example: Phase 2 trial of
Malaria vaccine candidate
• GMZ2: Hybrid of glutamate-rich protein and MSP3 + Alum
• Targeting the blood stage of the malaria parasite
• 4 clinical trials sites:
• CNRFP (Burkina Faso); Makarere (Uganda); Albert
Schweitzer Hospital (Gabon); Navrongo (Ghana)
• 2 European partners:
• SSI (Denmark); Tubingen University (Germany)
• 1747 children received 3 doses of 100 microgram
or rabies vx
• Close-out: Feb 2014
• Total budget: EUR 6.6 M (from EDCTP)
How does it work?
Annual Work Plan with call topics
First EDCTP2 in July 2014 (tbc)
Projects up to EUR 15 M
1. Integrated Activities
2. Participating States’
Initiated Activities
3. Joint Actions
with third parties (JA3s)
Participation of at least 2
European Participating States and
1 sub-Saharan African country
(collaborators from other EU
countries can also participate)
Selected and managed by EDCTP
Funding: 100% (+25% overhead)
Selected, funded and managed by
PSs according to national rules
Funding: 33% EDCTP + 66% PS
Co-funding of large activities with
other funders
Funding: <~25% from EDCTP
EDCTP Regional Networks of
Excellence for clinical trials
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Western Africa: WANETAM
Website: www.wanetam.org
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Burkina Faso
The Gambia
Ghana
Guinea-Bissau
•Mali
• Nigeria
• Senegal
• United States
Central Africa: CANTAM
Website: www.cantam.org
• Cameroon
• Congo, Republic of the
• Gabon
• France
• Germany
Eastern Africa: EACCR
Website: www.eaccr.org
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•
•
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Kenya
Sudan
Ethiopia
Tanzania
Uganda
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Germany
Sweden
United Kingdom
United States
Southern Africa: TESA
Website: www.tesafrica.org
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•
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Botswana
Malawi
Mozambique
South Africa
Zambia
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Zimbabwe
France
Germany
Netherlands
United Kingdom
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64 institutions in 21
African countries
Offered short- and
long-term training to
1000 researchers
Leveraged additional
€ 24 M
Published 38 peerreviewed papers
Strengthening of capacity for
clinical trials
Addressing inequality
Proliferation and sharing of
expertise and facilities
Achievements of EDCTP
funded grants
•
•
•
•
•
FDC paediatric formulation: contributed to the evidence base that led
FDA approval and WHO prequalification of a fixed-drug combination
formulation for the treatment of HIV in children (CHAPAS trial)
Influenced revision of 2010 WHO guidelines on PMTCT: 43% reduction in
HIV infections in infants and >50% reduction of PMTCT (Kesho Bora)
Informed national policy for the treatment of severe malaria: 3 novel ACT
drugs were found to be safe and efficacious in treating children with
uncomplicated malaria (4ABC study)
Establishment of four Regional Networks of Excellence for Conducting
Clinical Trials (NoE): the Central African Network for Tuberculosis, HIV/
AIDS and Malaria (CANTAM); the East African Consortium for Clinical
Research(EACCR); the Trials of Excellence for Southern Africa (TESA);
and the West African Network for TB, AIDS and malaria (WANETAM)
Establishment of the Pan-African Clinical Trials Registry (PACTR,
www.pactr.org), which is the only WHO-endorsed primary registry in
Africa.
Thematic project funding:
2003-2013
Area
Intervention
HIV/AIDS projects supported
by EDCTP
HIV clinical trials
•PMTCT (pregnancy and breastfeeding)
and paediatric treatment – 9 trials
•Nutritional support for patients starting
on ARVs – 1 trial
•TB/HIV co-infection – 1 trial
•Microbicides - 3 trials
•HIV vaccine – 7 trials
•Adherence to ART – 2 trials
•Evaluation of antiretroviral drugs - 7
trials
HIV/aids capacity building (16
projects)
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Feasibility studies in preparation
for clinical trials (e.g. preparing for
phase III vaginal microbicide trials
in Rwanda and Kenya)
Community and adolescent
involvement (e.g. exploring
attitudes towards participation in
clinical trials)
Establish baseline ranges of
biomarkers (e.g. Related to
vaginal environment in women
targeted for microbicide trials)
Epidemiological studies – site
characterisation
Funding mechanisms
• Minimum requirement: participation of at least 2 European
Participating States and 1 sub-Saharan African country
(collaborators from other EU countries can also participate)
• Integrated Activities: selected and managed by EDCTP
•
Funding: 100% (+25% overhead)
• Participating States’ Initiated Activities: selected, funded
and managed by Participating States according to national
rules
•
PSIA cofund: 33% EDCTP and 67% PSs
• Joint Activities: cofunding of strategic activities with other
funders
•
Funding: up to 33% from EDCTP
The second EDCTP
programme (EDCTP2)
• Public-Public Partnership
• Operates as an independent
legal entity (offices based in
the Netherlands and South
Africa)
• Financial and structural
support to phase I to IV
clinical trials in sub-Saharan
Africa
• EDCTP2 will operate from
2014-2024 (part of H2020)