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RER-CTO

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Reinforce the Ethical and Regulatory Ecosystem for the Transformation of Clinica...

Reinforce the Ethical and Regulatory Ecosystem for the Transformation of Clinical Trials Oversight in Ethiopia Tanzania and beyond Why RER-CTO?: The conduct of clinical trials requires competent ethics committee and regulatory authorities that can review clinical trial applications and monitor processes independently and efficiently ensuring the safety of cl... ver más

30/06/2027

Líder desconocido

926K€

Presupuesto del proyecto: 926K€

Líder del proyecto Líder desconocido

Fecha límite participación Sin fecha límite de participación.

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Financiación concedida El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2024-06-11

HORIZON-JU-GH-EDCTP3-2023-01-05: Strengthening ethics and regulatory... Expected Impact:Expected impacts of the calls under the 2023 work programme of the Global Health EDC...

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Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

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4 Participantes

UNIVERSITETET I OSLO

KAROLINSKA INSTITUTET

ARMAUER HANSEN RESEARCH INST...

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Duración del proyecto: 36 meses Fecha Inicio: 2024-06-11
Fecha Fin: 2027-06-30

Líder del proyecto Líder desconocido

Presupuesto del proyecto 926K€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto Why RER-CTO?: The conduct of clinical trials requires competent ethics committee and regulatory authorities that can review clinical trial applications and monitor processes independently and efficiently ensuring the safety of clinical trial participants, and the integrity and reliability of the generated data. The capacity of most African regulatory authorities regarding clinical trial review and oversight is weak due to poor infrastructure, limited resources both human and financial, lack of expertise, un-conducive working framework and lack of systems adequately supported by technology. Collaboration between academia, international organizations, National ethics committees (NECs) and national regulatory authorities (NRAs) are mandatory to produce sustainable regulatory skills and functional clinical trial oversight systems. The RER-CTO consortium consists of a group of well reputable clinical trial researchers, regulatory authorities, ethics committees, universities and research institutes in Ethiopia, Tanzania, Norway, and Sweden. Our aim is to achieve ethics and regulatory excellence and harmonization in sub-Saharan Africa in clinical trial oversight (CTO) by improving the legal and policy framework by identifying gaps and making recommendations, improving regulatory and research ethics oversight capacity and capability by digitalising the clinical trial oversight systems and developing training programs to strengthen competency of relevant stakeholders, and strengthening local, regional, and international collaborations and coordination of NECs and NRAs for clinical trial oversight by developing joint clinical trial review guidelines. These efforts are geared towards increasing clinical trials in sub-Saharan Africa, standardization of clinical trial review and monitoring processes, and promoting ownership, efficiency, linkages for data sharing, transparency, and accountability of clinical trial review processes.

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