WP1: Establishing a Filarial Clinical Trial and Research Platform (F-CuRE).
The F-CuRE seeks to harmonise phase 1 and phase 2 clinical trial procedures across the different participating countries. Modules to be carried out include implementation of International Council of Harmonisation/ Good Clinical Practice (ICH-GCP) procedures at all clinical trial sites under careful consideration of the special needs of filarial infections, joint GCP (and where appropriate, GLP) training for study clinicians, nurses and research scientists by regulatory authorities (e.g. Ghana FDA, CSC Bonn, etc.). Harmonised approaches on regulatory issues including monitoring strategies, pharmacovigilance processes, and electronic data capture systems to allow exchange and comparison of safety data and trial outcomes are integral aspects of the F-CuRE. Additionally, a biobanking unit will be created for all bio-specimens (blood, saliva, plasma, urine and other biological materials) collected during the clinical trials for future biomarker validation. Guidance on the establishment of a robust F-CuRE in partner African countries will be provided by experts from the DNDi and EDCTP. It is envisaged that once fully established, this clinical trial and research platforms will provide services for other diseases of the tropics, already existing or emerging (e.g. MRSA or multi-resistant Gram-negative infections). This task will be led by Dr. Alexander Yaw Debrah and supported by all the PIs of the various partner institutions.