Project: Enhancing capacity for Phase 1 clinical trials in Uganda

Acronym	Capa-CT (Reference Number: EDCTP-CSA-Ebola-353)
Duration	01/02/2016 - 31/01/2018
Project Topic	There are no licensed therapies for viral hemorrhagic fevers. Effective treatments for Ebola Virus Disease and other viral hemorrhagic fevers are urgently needed. However, in developing countries where the burden is greatest, there is often inadequate capacity to conduct the initial drug trials that are critical to understand the safety and possible efficacy of novel drug candidates. The CAPA-CT project was a two-year project funded by the European & Developing Countries Clinical Trials Partnership and World Health Organization Tropical Diseases Research. The project aimed to enhance capacity for the conduct of early phase clinical trials at the Infectious Diseases Institute, Makerere University College of Health Sciences, Uganda. The project aimed to accomplish this through four objectives. 1. Train clinical trial and support staff at IDI to conduct early phase clinical trials 2. Deploy equipment and tools to enhance performance of trained staff 3. Implement an enhanced quality system for clinical trial and support services processes 4. Establish robust local referral hospital linkages and facility transfer arrangements. During Year two, four training workshops were held including: Viral Hemorrhagic Fever Ebola Virus Disease Case Management, Advanced Cardiac Life Support, Physiologically Based Pharmacokinetic Modelling and Advanced Statistical Methods for Drug Development. Three of the four workshops were supported through a Professor-in-Residence Program supported by the project. Individual staff completed diploma training in Pharmaceutical Medicine (PHARMED) and a Master’s in Public Health related to Infection Prevention and Control. Translational laboratory audits were conducted. Laboratory staff continued work on pharmacology techniques to quantify drugs in body fluids. Emergency equipment, clinical and laboratory supplies were procured at IDI and emergency equipment was provided for Fort Portal Regional Referral Hospital. The research pharmacies at IDI were upgraded. Monitoring of performance, audit and feedback was performed for the management of severely ill patients at the IDI urgent care unit. A cost analysis was completed which informed selection of procurement strategy for ambulance services and audits of potential intensive care unit referral sites were performed. The project activities were disseminated through local and international meetings. The institute joined a major international consortium for filovirus drug development research, individual staff registered career advancements and one staff member secured a one-year Phase I clnical trial unit industry placement through a separate EDCTP Career Development award. Capa-CT project website
Project Results (after finalisation)	•Capacity development (Human resources): Delivery of four training workshops for staff of the Infectious Disease Unit Clinic on: Viral Hemorrhagic Fever Ebola Virus, Disease Case Management, Advanced Cardiac Life Support, Physiologically Based Pharmacokinetic, Modelling and Advanced Statistical Methods for Drug Development. •Capacity development (Systems and infrastructure): Implementation of laboratory audits, procurement of clinical and laboratory supplies, provision of emergency equipment for Fort Portal Regional Referral Hospital, upgrade of research pharmacies at Infectious Disease Unit, delivery of cost analysis to inform selection of procurement strategy for ambulance services.
Network	EDCTP2
Call	Coordination and Support Action: Research and capacity development in support of the EVD response

Project partner

Number	Name	Role	Country
1	Infectious Diseases Institute Limited	Coordinator	Uganda