Project Objectives
Be exposed to the cutting edge aspects of clinical trials at Merck in order to acquire advance knowledge and skills, and to develop training modules in systematic review, protocol development, advance statistical analysis, AE and SAE data management and analysis, leadership, communication and team working.
Project Summary
Centre Muraz is a biomedical research Centre located at Bobo-Dioulasso (Burkina Faso) experienced in the conduct of clinical trials in tropical diseases (HIV, malaria, Tuberculosis, Ebola etc.). However there is a need to strengthen the capacities of its new Department of clinical Research (DRC) and to ensure the long-term sustainability of thes DRC and then ensure the retention of local young scientists in Burkina Faso. The objectives of this grant are to acquire advance knowledge and skills in clinical trial design and operations at MERCK in Darmstadt (Germany), to Strengthen research capacity of Centre MURAZ by conducting training workshops at Centre MURAZ using the training module developed at MERCK, and by providing administrative support to the Department of Clinical Research of Centre MURAZ, and by building a long-term partnership for the conduct of clinical trial by the Merck in the new Department of Clinical Research of Centre MURAZ. During the reintegration phase, upon my return to Burkina Faso, it is planned to conduct statistical analysis and publish the existing data collected during previous studies conducted in Centre MURAZ, and to develop and submit a specific epidemiological study protocol in order to identify the potential participants that could be enrolled in future HIV and malaria trials in Bobo-Dioulasso (Burkina Faso). The first year of the action was dedicated to the implementation of the WP1: Training at MERCK in Darmstadt (Germany). It is related to the acquiring of advance knowledge and skills in clinical trial design and operations. During this first year, the first six months spent at Merck allowed me to start the rotation to different departments, in order to update my competency check list and to have a deep understanding of MERCK’s activities and organization. The other activities carried out during these first 6 months included: the tour of the MERCK headquarters at Darmstadt, Immersion in the Department of the Global Clinical Operation, attendance of the Clinical Trial Management (CTM) and governance meetings, completion of 194 training modules in Security, ICH GCP, GPVP), Merck’s Policies, SOPs and Work Instructions. To become proficient in clinical trials operations and study implementation, I have been involved in the management of a BTK inhibitors Phase I/II trials (TC with CRO, SMC meeting, meeting with the Clinical Trial Supply Team, and meeting with the Biostatistician etc.). In addition in order to start to build the strategic partnership with MERCK for the conducting of future clinical Trial at Centre MURAZ, I have adapted a site assessment Check list which has been shared with Centre MURAZ and I have learnt the drugs which are in Merck’s development pipeline. At MERCK, I am mentored by Dr. Oliver Leip (Director: Early Stage Clinical Operations, Global Clinical Operations) and David Schumacher (Head of Financial &performance planning&analysis). So far I have share two progress reports sent via email to my home institution (Centre MURAZ). Each report contains a list of best practices identified at Merck and could be implemented to strengthen the ongoing capacity development of the Centre MURAZ Department of Clinical Research (DRC). The impacts of my ongoing placement at MERCK Global Clinical Operations, are both at individual and institutional levels. The advance knowledge and skills I am acquiring will enhance my career development upon my return in Burkina Faso. They will help me to increase the quality of my research protocols and the number of my publications in peer-reviewed journals. This advanced knowledge and the other capacity development activities, will also sustain Centre MURAZ research platform by improving the administrative management of the Department of Clinical Research and by establishing a long term partnership with MERCK.
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