Project: EDCTP-TDR TMA 2015 - Zemsi Kala

Acronym	ARLA (Reference Number: TMA2015-1168)
Duration	01/05/2017 - 30/10/2018
Project Topic	I am a general practitioner. For the past 3 years, added to my routine clinical activities, I have been working with my institution in Cameroon, contributing as sub-investigator in various research programs and health promotion activities in the fields of HIV and Tuberculosis. I have also been actively involved at site level in the planning, set up and conduct of a GSK funded Ebola vaccine trial. I have acquired experience in implementing health and research projects in resource constrained settings, but for the specific field of clinical trials, I found myself deficient in various aspects namely the design of the study, the specific regulatory requirements and the trial reporting. I will be pursuing 12 months training at Janssen Pharmaceutica NV, Beerse Belgium with the main aim of gaining knowledge and practical expertise in many aspects in the set up and conduct of a clinical trial in SSA. Specific objectives: - To learn how to conduct feasibility and optimal study placement based on intelligence data, - To pro-actively identify investments to be made/gaps in terms of regulatory framework, capacity building (infrastructure/resources) and make proposals for operational readiness of investigational sites and countries. - To gain expertise in the management of complex multi-country trials with a cross-functional matrix trial management team - To learn various aspects of the trial from protocol design to clinical study reporting. - To actively build relationships /network with local stakeholders (academia, NGOs, local CROs or other development partners) and regulatory bodies in various countries of SSA and build a framework for operational excellence Reintegration activities that will be implemented at the home organisation over 6 months: - Organization of a 4 days training workshop on research methodology for 60 medical students - To use the knowledge received from the fellowship to design and implement 2 research projects alongside with the 2 medical students mentees - To set an online forum on which junior researchers can be discussing with more experienced researchers on issues faced on their projects
Project Results (after finalisation)	Capacity development (Human resources): completion of placement at host institution Janssen Pharmaceutica, Belgium: oWorked on Ebola vaccine portfolio; VAC52150EBL2002 (Phase 2 multi-countries and VAC52150EBL3001 (Phase 3 Ebola vaccine trial conducted in Sierra Leone) Ebola vaccine trial) oActively contributed to the Good Participatory Practices task force for implementation of the of AVAC/UNAIDS guidelines on in the Janssen’s HIV trials oUndertook various trainings (171) and obtained certificates of completion Capacity development (Human resources, Systems and Infrastructure): implementation of transferable skills at the Bamenda Center for Health Promotion and Research, Cameroon: o Organised knowledge transfer sessions for staff and a workshop for medical students; on topics such as team communication, data presentation, protocol development, GCP-ICH and informed consent. o Set up CROPS- Cameroon Research Online Platform for Students to provide mentorship for junior researchers oImproved samples management at the Site in Sierra Leone, resulting in the successful execution of 7 shipments (approx. 8000 samples) and with less than 5% of samples flagged for queries (compared to approx. 70% initially). Following his placament the fellow was admitted for an online Master’s in clinical trials at the The London School of Hygiene & Tropical Medicine (LSHTM).
Network	EDCTP2
Call	EDCTP-TDR Clinical Research and Development Fellowships 2015

Project partner

Number	Name	Role	Country
1	The Bamenda Center for Health Promotion and Research	Coordinator	Cameroon