STRENGTHENING THE REGULATORY FRAMEWORK TO UPGRADE ETHICAL REVIEW OF CLINICAL RESEARCH AND DRUGS SAFETY MONITORING IN CAMEROON (BREEDSAFCA)

In Cameroon, knowledge about the ethical and administrative evaluation of clinical research and participant protection remains limited; and the recommended system for detecting, reporting, investigating and preventing known and unknown adverse events following drug exposure exists, but it is not implemented in health facilities and does not work well in drug-using health programmes.

BREESAFCA (« Strengthening the regulatory framework to upgrade ethical review of clinical research and drugs safety monitoring in Cameroon ») is a project that aims to strengthen the protection of research participants and pharmacovigilance through the strengthening of regulatory frameworks in research ethics and pharmacovigilance, the establishment of Human Health Research Ethics Committees and pharmacovigilance units, and the training of Human Health Research Ethics Committee

members, researchers, and pharmacovigilance personnel in Cameroon. This project is funded by EDCTP (« European&Developing Countries Clinical Trial Partnership ») and is implemented by the Division of Operational Health Research, the Directorate of Pharmacy, Medicines and Laboratories of the Ministry of Public Health of Cameroon, the Research Ethics Committee and the NGO M.A. SANTE (Better Access to Health Care). The prerequisite for the above-mentioned training is the conduct of a needs assessment study on training in research ethics and pharmacovigilance by M.A. SANTE. It is expected that this study will identify and prioritise training needs and targets in terms of the protection of research participants so that these can be used in the programming and design of the training modules planned within the framework of the BREEDSAFCA project.

RESEARCH QUESTION

What are the different training needs in ethics for the protection of research participants and in pharmacovigilance in Cameroon

OBJECTIVES

Assess training needs for the protection of research participants and in pharmacovigilance in Cameroon.

Methodology

It was a descriptive cross-cutting study that collected data on one hand on the training needs in research ethics from members of Human Health Research Ethics Committees, researchers, and training institutes; and on the other hand on the training needs in pharmacovigilance for health personnel, pharmacists, health training and health programmes in Cameroon using specific questionnaires pre-tested and administered face-to-face. The data was collected during the period of June 2020 by trained investigators.

ACTIVITIES

The activities that are carried out so far are :

– Development of the protocol and data collection tools ;

– Pretext of the data collection tools ;

– Submission of the Protocol to the National Research Ethics Committee;

– Submission of the protocol to the different target institutions of the project for obtaining administrative authorisations;

– Development of the digital tools for the survey;

– Training of supervisors and investigators;

– Data collection;

– Data processing;

Future activities to be carried out are data analysis, report writing and dissemination of results to project partners. The results of this research will be used for the programming and design of the training modules planned within the framework of the BREEDSAFCA project.