Periodic Reporting for period 1 - SCALE-IT (SCALING UP CAPACITY TO SUPPORT CONDUCT OF CLINICAL TRIALS IN THE EAST AFRICAN COMMUNITY)
Reporting period: 2023-06-01 to 2024-11-30
The EAC has experienced significant increase in volume and complexity of clinical
research driven by epidemics of emerging and remerging infectious diseases such as HIV, Ebola and COVID-19,
requiring expertise in scientific and ethical review and conduct of research and a robust and pragmatic research
regulatory framework. The overall goal of the proposed project is to strengthen scientific and ethics capacity in
EAC for high quality research review, conduct and oversight, at international standards.
The specific objectives are:
1.To train National Research Regulatory Agency (NRRA) personnel, Research Ethics Committee (REC) members,
researchers and clinicians on scientific and ethics review and conduct of research with emerging and complex study
designs including adaptive platform trials
2.To train NRRA personnel and REC members and clinical trials monitors
on monitoring and pharmacovigilance of clinical trials and
3.To train NRRA, REC and research administrators on
personal effectiveness and leadership skills (PELS) to manage the increasingly complex research processes.
Methods: We will implement this project within a partnership of Infectious Diseases Institute (IDI), Uganda;
Epicenter, France (EU partner) and Kenya Medical Research Institute, and participants from the six partner states of
the EAC, with the East African Health Research Commission as the nucleus for coordination and dissemination of
results. This proposal fits within the scope of GH-EDCTP3-2022-01-05 call, whose aim is to strengthen clinical
research capacity and improve efficiency of the regulatory environment for effective development, delivery and
uptake of new and improved safe health technologies and rapid response to emerging epidemics guaranteeing
international standards and attainment of SDG3 “Ensure healthy lives and promote well-being for all at all ages in
sub-Saharan African countries”
research driven by epidemics of emerging and remerging infectious diseases such as HIV, Ebola and COVID-19,
requiring expertise in scientific and ethical review and conduct of research and a robust and pragmatic research
regulatory framework. The overall goal of the proposed project is to strengthen scientific and ethics capacity in
EAC for high quality research review, conduct and oversight, at international standards.
The specific objectives are:
1.To train National Research Regulatory Agency (NRRA) personnel, Research Ethics Committee (REC) members,
researchers and clinicians on scientific and ethics review and conduct of research with emerging and complex study
designs including adaptive platform trials
2.To train NRRA personnel and REC members and clinical trials monitors
on monitoring and pharmacovigilance of clinical trials and
3.To train NRRA, REC and research administrators on
personal effectiveness and leadership skills (PELS) to manage the increasingly complex research processes.
Methods: We will implement this project within a partnership of Infectious Diseases Institute (IDI), Uganda;
Epicenter, France (EU partner) and Kenya Medical Research Institute, and participants from the six partner states of
the EAC, with the East African Health Research Commission as the nucleus for coordination and dissemination of
results. This proposal fits within the scope of GH-EDCTP3-2022-01-05 call, whose aim is to strengthen clinical
research capacity and improve efficiency of the regulatory environment for effective development, delivery and
uptake of new and improved safe health technologies and rapid response to emerging epidemics guaranteeing
international standards and attainment of SDG3 “Ensure healthy lives and promote well-being for all at all ages in
sub-Saharan African countries”
- Stakeholders meeting held in November 2023, involved 40 members from across the EAC partner states. The meeting aimed at providing guidance in areas of greatest need consquently improving the curriculum developement and review
-TAC meeting attended by over 11 members selected from across the EAC partner states was held in decemeber 2024. The meeting saw the review and approval of the curricula and memebers guided on implementation process of the project
-The three curricula on Emerging and complex study designs, clinical trials monitoring and perosonal effectiveness and leaderships skills was approved
-Since 2024 Jan up to date, the project has carried out training of 530 members including (research ethic committee members, National regulatory authority members, researchers, clinicians in research, REC and project admins and clinical trial monitors) on the 3 objectives
-TAC meeting attended by over 11 members selected from across the EAC partner states was held in decemeber 2024. The meeting saw the review and approval of the curricula and memebers guided on implementation process of the project
-The three curricula on Emerging and complex study designs, clinical trials monitoring and perosonal effectiveness and leaderships skills was approved
-Since 2024 Jan up to date, the project has carried out training of 530 members including (research ethic committee members, National regulatory authority members, researchers, clinicians in research, REC and project admins and clinical trial monitors) on the 3 objectives
The project has yielded significant advancements in research capacity-building across the East African Community (EAC) partner states, surpassing initial expectations in several key areas.
Enhanced Knowledge and Competency in Emerging and Complex Study Designs (ECSDs): Observed knowledge shift from 62% to 80% (pre-test vs. post-test) was observed among trained National Research Regulatory Agency (NRRA) personnel, Research Ethics Committee (REC) members, researchers, and clinicians.
Qualitative feedback from participants indicated a deepened understanding of adaptive platform trials and other complex designs, improving their ability to critically review clinical trial protocols.
The curriculum could now serve as a benchmark for future regulatory and ethical training programs in the East African Community (EAC)
Training on clinical trials monitoring and pharmacovigilance resulted in a knowledge gain from 60% to 79%, equipping NRRA personnel, REC members, and clinical trial monitors with essential clinical trial monitoring skills and knowledge. This enhanced expertise supports more rigorous monitoring of clinical trials, aligning with international standards for ethical and scientific integrity.
The Personal Effectiveness and Leadership Skills (PELS) training led to a knowledge shift from 64% to 85%, demonstrating improved leadership capacities among NRRA, REC, and research administrators.
Participants reported greater confidence in managing complex research processes, improving decision-making and operational efficiency in regulatory institutions.
The standardized curricula on ECSDs, clinical trial monitoring, and PELS can be adopted by national regulatory agencies and academic institutions, ensuring long-term capacity strengthening.
Expanding the training to French-speaking stakeholders in Burundi and beyond could further enhance regional harmonization.
There is a need to explore the long-term impact of these trainings on regulatory decision-making and research oversight.
Future research could assess the application of training knowledge in real-world clinical trial approvals and monitoring processes.
Strengthening cross-border collaboration between NRAs and RECs in the EAC will facilitate a harmonized regulatory framework for clinical research oversight.
Engagement with global regulatory bodies (e.g. WHO, EMA, FDA) can ensure alignment with best practices and international ethical standards.
Expanding the IDI e-learning platform to provide continuous professional development (CPD) certification could increase accessibility and scalability of training.
Developing multi-language versions of the curricula (English, French, Swahili) would further enhance inclusivity across diverse stakeholder groups.
Enhanced Knowledge and Competency in Emerging and Complex Study Designs (ECSDs): Observed knowledge shift from 62% to 80% (pre-test vs. post-test) was observed among trained National Research Regulatory Agency (NRRA) personnel, Research Ethics Committee (REC) members, researchers, and clinicians.
Qualitative feedback from participants indicated a deepened understanding of adaptive platform trials and other complex designs, improving their ability to critically review clinical trial protocols.
The curriculum could now serve as a benchmark for future regulatory and ethical training programs in the East African Community (EAC)
Training on clinical trials monitoring and pharmacovigilance resulted in a knowledge gain from 60% to 79%, equipping NRRA personnel, REC members, and clinical trial monitors with essential clinical trial monitoring skills and knowledge. This enhanced expertise supports more rigorous monitoring of clinical trials, aligning with international standards for ethical and scientific integrity.
The Personal Effectiveness and Leadership Skills (PELS) training led to a knowledge shift from 64% to 85%, demonstrating improved leadership capacities among NRRA, REC, and research administrators.
Participants reported greater confidence in managing complex research processes, improving decision-making and operational efficiency in regulatory institutions.
The standardized curricula on ECSDs, clinical trial monitoring, and PELS can be adopted by national regulatory agencies and academic institutions, ensuring long-term capacity strengthening.
Expanding the training to French-speaking stakeholders in Burundi and beyond could further enhance regional harmonization.
There is a need to explore the long-term impact of these trainings on regulatory decision-making and research oversight.
Future research could assess the application of training knowledge in real-world clinical trial approvals and monitoring processes.
Strengthening cross-border collaboration between NRAs and RECs in the EAC will facilitate a harmonized regulatory framework for clinical research oversight.
Engagement with global regulatory bodies (e.g. WHO, EMA, FDA) can ensure alignment with best practices and international ethical standards.
Expanding the IDI e-learning platform to provide continuous professional development (CPD) certification could increase accessibility and scalability of training.
Developing multi-language versions of the curricula (English, French, Swahili) would further enhance inclusivity across diverse stakeholder groups.