The EDCTP funded ECOWAS RegECs project 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.
West Africa's clinical research initiatives, especially for Lassa fever, Ebola, and COVID-19, require stringent regulation and ethical oversight. Work Package 2 (WP2) of the ECOWAS-RegECs project aims to address challenges faced by NRAs and ECs by offering targeted training and capacity-building for regulators and ethics professionals.
The project titled, Practical Strengthening of Regulatory and Ethics Oversight on Clinical Trials in West Africa using Lassa Fever Vaccine Development Projects is expected to last for 36 months. The primary objective is to strengthen the technical skills and capacity of NRAs and ECs in ECOWAS member states by offering simulations and observational opportunities related to the scientific advice and clinical trial application (CTA) processes. By using a practical, hands-on approach, this work package seeks to ensure that regulatory and ethics bodies can effectively oversee clinical trials, thereby protecting participants' safety and ensuring the integrity of the research. The project officially commenced in November 2023.
This training module specifically targets the assessment of the First-in-Human Clinical Trial Application (CTA) for INO-4500, an investigational vaccine developed by Inovio Pharmaceuticals for the prevention of Lassa fever.
The training uses online simulations, joint assessments, and discussions via the AVAREF platform, focusing on the entire clinical trial application (CTA) assessment process.
Facilitated Virtual Joint Advice Session
The first virtual scientific advice simulation took place from 31st July 2024 – 1st August 2024 using the first-in-human Clinical Trial Application (CTA) for INO-4500. Trainees participated in orientation and preparatory training on the CTA process. They used AVAREF templates and reviewed CTA documentation individually or in groups, with optional supervisory support, to prepare for the joint assessment.
Lessons Learned Exercise
A virtual lessons-learnt session was held on 1st August 2024 via Zoom. 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.
Self-Benchmarking Exercise
As part of the activities of Work Package 3 (WP3), which focuses on enhancing the regulatory systems and clinical trial oversight functions of two National Regulatory Authorities (NRAs) in the West African region, experts from the Food and Drugs Authority (FDA) conducted a two-week assisted self-benchmarking of the regulatory systems (RS) and clinical trial (CT) oversight functions of the Liberia Medicines and Health Regulatory Authority (LMHRA) using the World Health Organization’s (WHO) Global Benchmarking Tool (GBT).
The exercise began with an introductory training session on the GBT to equip participants with the necessary skills to understand and utilize the tool. Over 15 staff members from the LMHRA participated in this training, with 12 successfully passing the computerized self-test and receiving certificates of completion from WHO.
The self-benchmarking exercise was conducted via Zoom using video conferencing. Two breakout rooms were created for the respective regulatory functions, with officers assigned based on their areas of expertise. Experts from the FDA engaged LMHRA officers in an interactive session, discussing the sub-indicators of the RS and CT functions. Relevant supporting documents were uploaded to a shared MS Teams folder, where FDA experts guided LMHRA staff on how to meet the requirements for each sub-indicator. In cases where the LMHRA lacked certain documents, the experts provided sources and advice on how to develop them.
The FDA experts will maintain close contact with LMHRA officers as they continue their desk review of the supporting evidence uploaded to the MS Teams folder.
Below is a picture taken during the exercise.
Looking Forward
At the end of the 36 months, 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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