Background The West African Network for Clinical Trials of Antimalarial drugs second edition (WANECAM2) is an Africa-Europe consortium funded by EDCTP2. In collaboration with Novartis and Medicines for Malaria Venture WANECAM2 is contributing to the development of KAF156-LUM SDF and improving clinical studies capacity in the sub-Region. A novel team was identified in Niger, where clinical trial capacity is lagging and was targeted for focused capacity building.

Methods A series of trainings in clinical trial procedures, GCP and GLP were provided by the MRTC-team in July 2019 in Bamako, Mali. A second GCP training was done on site in Niamey, Niger by the MRTC in November 2019 where the entire Niger team participated. Two Niger Biologists visited the MRTC for training and certification in August 2022 while one physician received advanced training in clinical trial procedures, embedded in one of the Mali trial sites. Three nurses were trained on the REDcap platform on medication data entry. One PhD student and one MSc student were registered at USTTB, Mali. Site visits of WANECAM2 teams in Burkina-Faso were organized for the Niger leadership.

Results From November 2019 to December 2020, with on-site assistance from two experienced physicians and one laboratory certified technician from Mali, the Niger team conducted a Phase IV in vivo study on the efficacy of Artesunate-Pyronaridine versus Artemether-Lumefantrine and enrolled 240 participants. A second study on biological parameters completed in May 2022 with a total of 1052 participants enrolled. Quality control and data analysis are underway. A new building was refurbished and fully equipped.

Conclusion A new study team and infrastructure was built from scratch in Niger through South-South collaboration and is ready to contribute to an upcoming Phase III trial.

Funding: WANECAM2 which is part of the EDCTP2 (RIA2017T-2018 WANECAM2).