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Project Topic
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The main goal of my placement at Merck KGaA was to become proficient in clinical trials, design and operations. During my placement in the Global Clinical Operations I was under the mentorship of Dr. Oliver Leip, Director; Early Stage Clinical Operations, and David Schumacher; Head of Financial Performance, Planning & Analysis. With both mentors I held regular meetings to keep updated with various objectives of the programme. The meetings also provided a learning platform in the form of didactic materials and discussions on topics including clinical trial management, clinical trials operations and study implementation, finance and forecasting, KPIs and benchmarking and project management systems. Other discussions provided a sneak peak into the Global Schistosomiasis Alliance and the ongoing clinical trials to optimise use of praziquantel in children. I completed some learning materials which are provided in-house (My learnings), attended seminars, town hall meetings and a training session in Corrective and Preventive Action (CAPA). I then remained in RCO under the guidance of Jan Sadewasser (Senior Clinical Research Manager). I was allocated specific tasks on the study ENCORE. This was an observational trial for recurrent metastatic head and neck cancer and the use of Erbitux (Cetuximab) which is ongoing in 5 countries. I attended project meetings and had an opportunity to oversee some activities including protocol amendments, drug safety and SAE reporting, data management, risk assessment, SAP, interim snapshot analysis and conference abstract preparation. This involved regular interactions with Medical Affairs, Drug Safety and Data Management departments as well as the CROs. After I was introduced to this trial and the trial team (both, internally as well as the Front-End and Back-End CRO), I took over the team leadership focusing on an Interim Analysis for this trial. I set team deadlines and encouraged the team in problem solving of upcoming issues related to the above task. During the time at Merck, I was also exposed to various networking opportunities which would support capacity building for clinical research in Africa. Although these are outside the scope of the work proposed in the re-integration period, the activities could complement the efforts being put in place for capacity building and thus can be conducted by other fellow researchers in our institutions. 1. As there is increased interest in clinical trials in Africa and other LMIC regions, it is important to understand the current status and needs at the local level. Together with another EDCTP Fellow, Isidore Traore, we proposed to assess the capacity for conducting clinical trials in selected diseases including immunology, oncology and endocrinology, which are focus areas for Merck. This kind of checklist provides clinical researchers an overview of gaps and needs for resources which will enable successful implementation of clinical trials in Africa and other LMICs. The questionnaire based survey was developed and will be piloted at our respective institutions in Burkina Faso and Zimbabwe. In both cases we anticipate that the work will be published and potentially develop an electronic database in the future. 2. The Merck CAP programme aims to build capacity for clinical research in Africa, through education of health professionals, community engagement and provision of basic services. This programme is active in various African countries already. During my time at Merck, I had the opportunity to explore this possibility and indicate interest on behalf of my institution for participating in such a programme. Of interest is the growing number of cases with noncommunicable diseases (NCDs) such as diabetes and cancer and yet with the background of infectious diseases. There is need to tackle such health challenges in a combined manner. This could ensure that the same level of attention given to diseases such as HIV and TB is also given to NCDs which are currently neglected in terms of their surveillance, management and availability of medicines. We aimed to find areas of common interest with the Merck Cap programme towards addressing this gap. 3. Diabetes cases are increasing in Africa and yet there is limited research to indicate the true burden as well as improving preventive and treatment strategies. A discussion was held with Medical Head Dr Ulrike Gottwald-Hostalek, MD) who agreed that there is a need for actions to increase the awareness on diabetes and to conduct in Africa observational and clinical trial on this disease. In future there could be a possibility to develop partnershps with local health authorities and NGOs to support screening programmes and to also include African populations in future observational trials which could expand the market for current drugs.
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