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

This project aims to strengthen the regulatory framework to improve the ethical review of clinical research and the monitoring of drug safety in Cameroon.

Funder: EDCTP (European & Developing Countries clinical Trials Partnership)

Partners

  • Cameroon Ministry of Public Health
  • Division of Operational Health Research (DROS)
  • Directorate of Pharmacy, Medicines and Laboratories (DPML)
  • National Ethics Committee of Human Health Research (CNERSH)
  • A. SANTE (Meilleur Accès aux soins de Santé)

Period: 1st November, 2018 to 30th April, 2021.

Project team :

  • Principal investigator : ATEUDJIEU Jérôme (DROS)
  • Focal point CNERSH: OKOMO ASSOUMOU Marie Claire
  • Focal point M.A. SANTE : Miss DOUANLA KOUTIO Ingrid Marcelle
  • Project Coordinator : ZOUNG KANYI BISSEK Anne Cécile(DROS)
  • Focal point DPML: Dr MBWE MPOH Maurice
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Abstract

The burden of tropical infectious diseases remains a hindrance for the development of African countries. Research is needed to provide evidence guiding decision makers in the process of defining health policies and head of health programs in developing health interventions. In addition, it is needed in the development of drugs and vaccines which are necessary for the primary and secondary preventions of these diseases.

Many studies and reports have underlined weaknesses in most developing countries regarding research participant protection and post market drug safety monitoring. Thus, significantly contributing in limiting population access to research results and marketed drugs. The actual situation in Cameroon is characterized by limited coverage of some key aspects of research participant protection and drugs safety monitoring by existing regulations. The prerequisite indispensable for good performance of existing research ethics committees (RECs) and regulatory bodies are still in its early stage of development. The distribution of preparedness of researchers and RECs’ members to protect research participants and of healthcare personnel to participate in drug safety monitoring is yet to be mapped. The recommended system to detect, report, investigate and prevent adverse events following exposure to drugs performs poorly in one out of eight health programs using drugs and is not implemented in health facilities.

M.A. SANTE contributes to the present project by conducting training needs assessment of key actors involved in research participants protection and drugs safety monitoring. This is being done by developing two research protocols that were approved by competent ethics committee and are being implemented by conducting surveys targeting RECs, health training and research institutions, REC members and researchers to identify needs and targets of interventions to improving research participants protections and drugs safety monitoring in Cameroon.

It is expected from the M.A. SANTE’s contribution, to provide evidence that will be used to guide actors in charge on improving the:

  • conditions of RECs functioning and performances in protocol evaluation,
  • organization and implementation of pharmacovigilance activities in health programs and health facilities,
  • curricular development regarding research participants’ protection and drugs safety monitoring in health training institutions,
  • skills of RECs members and researchers in insuring research participants’ protection
  • skills of health personnel in contributing in drugs safety monitoring

Progress of activities

  • Development of protocol, procedures and tools
  • Training of field teams
  • Data collection
  • Meeting for report drafting

Publication