During the past decades researchers from Cameroon has positioned the country has a reference in clinical
Trials in the Central African region. As an indication, a search in “clinical trial.gov” listed 96 trials registered in Cameroon against 53 in Gabon, 35 in Congo 7 in chad, 7 in the Central African Republic and 3 in Equatorial Guinea. Despite this, the country still lack the necessary regulation to efficiently guide the researchers and ensure that the right and safety of CT trials participants are safeguarded.

This is of particular concern as research activities are on the rise and it is expected that regulators will be required to oversee an increased number of clinical trial applications probably more complex in design or with regard to the nature of the investigational medicinal products assessed.

 

The S-ROC project is an EDCTP funded project initiated by the Ministry of Health of Cameroon. It is designed as a regulatory/capacity strengthening project and aims at addressing the lack of Clinical Trials regulation in Cameroon. It involves the participation of the Direction of Operational Research and the Direction of Pharmacy, Drug and Laboratory at the Ministry of Health of Cameroon as well as MEDRAC-Africa. The S-ROC project has officially been launched in June 2021 by the General Secretary of the Minister of Health of Cameroon.

 

Since then substantial milestone has been reached:
-    The project consortium was able to finalize the preparation of a draft of the first CT regulation and guideline for Cameroon. These drafts were validated during a series of stakeholder validation workshops.
-    An assessment of the training need for the regulators of the National Regulatory Authority (NRA) was performed and a training curriculum was developed 
-    A regional workshop on Clinical Trial Harmonization in the Central African Region was organized. This workshop hosted by the Gabon NRA in Libreville. It was opened by the Minister of Health of Gabon and was chaired by the General Secretary of the Minister of Health of Cameroon. The meeting conveyed regulators from Cameroon, the republic of Congo, Equatorial Guinea and the Central African Republic.

The developed clinical trials regulation and guideline are expected to significantly change the research landscape in Cameroon, provide an elaborated framework to researchers and sponsors and increase the safety of subjects participating in clinical trials.