The ECOWAS-RegECs project, funded by the European and Developing Countries Clinical Trials Partnership (EDCTP), is a critical initiative aimed at bolstering the regulatory and ethical frameworks for clinical trials across the West African region. This project, implemented under the auspices of the Economic Community of West African States (ECOWAS), is designed to enhance the capabilities of National Regulatory Authorities (NRAs) and Ethics Committees (ECs) in ECOWAS member states, ensuring that they are well-equipped to oversee and regulate clinical trials in alignment with international standards.
Rationale
West Africa has been the focus of several clinical research initiatives, especially in response to emerging and re-emerging infectious diseases like Lassa fever, Ebola, and COVID-19. The Lassa fever virus, in particular, poses a significant public health threat in the region, with recurrent outbreaks that necessitate urgent development and testing of vaccines and therapeutics. Effective regulation and ethical oversight are paramount in ensuring that clinical trials for these interventions are conducted safely, ethically, and with scientific rigor.
Despite ongoing efforts, many NRAs and ECs in West Africa face challenges such as limited resources, lack of technical expertise, and varying levels of experience in managing complex clinical trials, particularly those involving novel vaccine candidates. To address these challenges, Work Package 2 (WP2) of the ECOWAS-RegECs project focuses on providing targeted training and capacity-building opportunities for regulators and ethics professionals across the region.
Trainings
The combined training module (simulations 3 and 4) involves a scientific advice simulation and an assessment of a clinical trial application on an investigational vaccine developed by Emergent for the prevention of Lassa fever. It specifically targets the assessment of an investigational vaccine developed by Emergent for the prevention of Lassa fever. The training uses online simulations, joint assessments, and discussions via the African Vaccine Regulatory Forum (AVAREF) platform, focusing on the entire clinical trial application (CTA) assessment process. AVAREF is a strategic platform that has been instrumental in harmonizing regulatory processes across Africa, providing a collaborative environment for regulators and ethics committees to share best practices and align on decision-making processes.
As with the previous simulations, the selection of this specific CTA for the training is deliberate, since it provides a relevant and timely case study that aligns with the pressing public health needs of the region.
Facilitated Virtual Joint Advice Session
The first virtual scientific advice simulation took place from 31st July 2024 to 1st August 2024 via Zoom using the first-in-human Clinical Trial Application (CTA) for INO-4500. Prior to the virtual simulation, which took place on 31st July 2024, trainees participated in an orientation and preparatory training on the scientific advice process. They provided responses to the developers' questions, which were discussed and finalized during the simulation meeting.
Lessons Learned Exercise
A virtual lessons-learned session was held on 1st August 2024. In this session, participants took part in a debriefing session to reflect on the process, discuss challenges, and identify lessons learned to improve future assessments and encourage continuous learning.
Collaborations
To be able to achieve the objectives of the project, the FDA Ghana is collaborating with the under-listed NRAs:
National Agency for Food and Drug Administration and Control (NAFDAC) and National Health Research Ethics Committee (NHREC), Nigeria
Liberia Medicines and health Products Regulatory Authority (LMHRA) and National Research and Ethics Board (NREB), Liberia
National Medicines Regulatory Authority (NMRA) and Ethics Committee, Sierra Leone
Autorité Ivoirienne de Régulation Pharmaceutique (AIRP), Côte d’Ivoire
Agence Béninoise du Médicament et des autres produits de santé (ABMed) and Comité National Ethique pour la Recherche en Santé (CNERS), Benin
Agence sénégalaise de Réglementation pharmaceutique (ARP), Senegal
Entidade Reguladora Independente da Saúde (ERIS), Cape Verde
Department of Pharmacy, Medicines and Laboratories, CHAD
AFRAME, Guinea Bissau
Medicines Control Agency (MCA), Gambia
Agence Nigérienne de Presse (ANRP), Niger
Comité de Bioéthique pour la Recherche en Santé (CBRS), Togo
WP2 First Joint Scientific Advice Simulation Activity
The first joint scientific advice simulation activity under WP2 was successful, and based on the success and challenges identified, it is expected that the next activity under the work package, which is a virtual joint CTA assessment, would see a tremendous improvement.
Looking Forward
At the end of the period, it is expected that FDA regulators would have advanced their skills and technical knowledge to effectively assess clinical trial documents and train researchers. Additionally, regulators from other African National Medicines Agencies will apply these skills to harmonize clinical trial regulations across their countries.
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