Summary
BACKGROUND
There are few research ethics committees (RECs) with capacity to review and provide oversight for clinical trials in Sub-Saharan Africa (SSA), and hardly any national accreditation systems used to evaluate the quality of review by these RECs. Although digital protocol submission systems improve RECs efficiency, up to 48% RECs in SSA still use paper-based systems. Additionally, many (single country) clinical trials in SSA are not registered with any internationally recognized clinical trials registry. The SECRET project seeks to address these challenges in Uganda and Ethiopia, by establishing national RECs accreditation systems, building capacity of RECs to review clinical trials (including during outbreaks and emergencies), establishing national clinical trials registries linked to the Pan African Clinical trial registry (PACTR), and developing digital protocol submission systems.
METHODOLOGY
The SECRET project includes partners that have worked together in other EDCTP-funded projects, to address the identified gaps through four objectives and six work packages. We will leverage the experience of the Uganda National accreditation system to establish a national accreditation system for Ethiopia and accredit at least two RECs in Ethiopia and two in Uganda. We will also leverage the expertise of the PACTR to set up the Uganda National Clinical Trial Registry. Nuvoteq that have experience in digital solutions for health care services will support Ethiopia to set-up the digital protocol submission systems. We shall also leverage the expertise of Makerere University bioethics training unit and the National Drug Authority of Uganda to build capacity for clinical trial review and oversight for the RECs to be accredited. The Uganda National Health Research Organisation and Institute of Tropical Medicine in Antwerp, which are the coordination institutes, have worked together on ALERRT, an epidemics preparedness consortium funded by EDCTP.
There are few research ethics committees (RECs) with capacity to review and provide oversight for clinical trials in Sub-Saharan Africa (SSA), and hardly any national accreditation systems used to evaluate the quality of review by these RECs. Although digital protocol submission systems improve RECs efficiency, up to 48% RECs in SSA still use paper-based systems. Additionally, many (single country) clinical trials in SSA are not registered with any internationally recognized clinical trials registry. The SECRET project seeks to address these challenges in Uganda and Ethiopia, by establishing national RECs accreditation systems, building capacity of RECs to review clinical trials (including during outbreaks and emergencies), establishing national clinical trials registries linked to the Pan African Clinical trial registry (PACTR), and developing digital protocol submission systems.
METHODOLOGY
The SECRET project includes partners that have worked together in other EDCTP-funded projects, to address the identified gaps through four objectives and six work packages. We will leverage the experience of the Uganda National accreditation system to establish a national accreditation system for Ethiopia and accredit at least two RECs in Ethiopia and two in Uganda. We will also leverage the expertise of the PACTR to set up the Uganda National Clinical Trial Registry. Nuvoteq that have experience in digital solutions for health care services will support Ethiopia to set-up the digital protocol submission systems. We shall also leverage the expertise of Makerere University bioethics training unit and the National Drug Authority of Uganda to build capacity for clinical trial review and oversight for the RECs to be accredited. The Uganda National Health Research Organisation and Institute of Tropical Medicine in Antwerp, which are the coordination institutes, have worked together on ALERRT, an epidemics preparedness consortium funded by EDCTP.
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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/101145783 |
| Start date: | 01-07-2024 |
| End date: | 30-06-2027 |
| Total budget - Public funding: | 1 148 180,00 Euro - 1 148 180,00 Euro |
Cordis data
Original description
BACKGROUNDThere are few research ethics committees (RECs) with capacity to review and provide oversight for clinical trials in Sub-Saharan Africa (SSA), and hardly any national accreditation systems used to evaluate the quality of review by these RECs. Although digital protocol submission systems improve RECs efficiency, up to 48% RECs in SSA still use paper-based systems. Additionally, many (single country) clinical trials in SSA are not registered with any internationally recognized clinical trials registry. The SECRET project seeks to address these challenges in Uganda and Ethiopia, by establishing national RECs accreditation systems, building capacity of RECs to review clinical trials (including during outbreaks and emergencies), establishing national clinical trials registries linked to the Pan African Clinical trial registry (PACTR), and developing digital protocol submission systems.
METHODOLOGY
The SECRET project includes partners that have worked together in other EDCTP-funded projects, to address the identified gaps through four objectives and six work packages. We will leverage the experience of the Uganda National accreditation system to establish a national accreditation system for Ethiopia and accredit at least two RECs in Ethiopia and two in Uganda. We will also leverage the expertise of the PACTR to set up the Uganda National Clinical Trial Registry. Nuvoteq that have experience in digital solutions for health care services will support Ethiopia to set-up the digital protocol submission systems. We shall also leverage the expertise of Makerere University bioethics training unit and the National Drug Authority of Uganda to build capacity for clinical trial review and oversight for the RECs to be accredited. The Uganda National Health Research Organisation and Institute of Tropical Medicine in Antwerp, which are the coordination institutes, have worked together on ALERRT, an epidemics preparedness consortium funded by EDCTP.
Status
SIGNEDCall topic
HORIZON-JU-GH-EDCTP3-2023-01-05Update Date
20-09-2024
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Organisations
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| PRINS LEOPOLD INSTITUUT VOOR TROPISCHE GENEESKUNDE (Coördinator)
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| MAKERERE UNIVERSITY
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| MINISTRY OF EDUCATION OF FEDERAL REPUBLIC OF ETHIOPIA,
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| NUVOTEQ (PTY) LTD
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| SAINT PAUL MILLENNIUM MEDICAL COLLEGE
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| SOUTH AFRICAN MEDICAL RESEARCH COUNCIL
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| THE NATIONAL DRUG AUTHORITY
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| UGANDA NATIONAL COUNCIL FOR SCIENCE AND TECHNOLOGY
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| UGANDA NATIONAL HEALTH RESEARCH ORGANISATION