It is now exactly one year after return to my home institute completing the one year WHO/TDR clinical development fellowship (CDF) program hosted by Astellas pharma Global Development, IL USA. After my return, I settled back within a month and resumed working as a lecturer in the Department of Internal Medicine, University of Gondar (UoG). I am one of the few female medical doctors working as a lecturer and researcher in the university. Based on my experience, I was also given the opportunity to run a new clinical trial as a principal investigator that is starting at our site. This is a clinical trial on use of Tafenoquine for vivax malaria and it is sponsored by GlaxoSmithKline limited (GSK). The research coordinators from GSK side were happy to know that I had the WHO/TDR fellowship program and really encouraged me. Since I was hosted by a drug company, during my fellowship, it gives me tremendous experience in international and country specific regulatory requirements and a lot more, which makes working with GSK easier for me. Also it gave me the experience to communicate, lead and handle the clinical trial process from the inception. Currently I am leading 24 team members, which include co-investigator physicians, nurses, laboratory technicians and outreach coordinator. I have facilitated trainings on Good Clinical Practice, the protocol, standard operating procedures and good documentation practices.
I have got the opportunity to work with several partners including Institute of Tropical Medicine (ITM), Antwerp; University of Vienna, Austria; Drugs for Neglected Diseases initiative, Geneva; Medicine for malaria venture (MMV), Geneva on different research projects. My collaborative research work focuses on the major diseases of public health significance here in Ethiopia such as Malaria, Leishmaniasis, Tuberculosis and HIV.
We are now applying for EDCTP together with MMV for a new anti-malarial drug development. I am participating actively as a local principal investigator in grant application processes with our partners. My experience from the fellowship program has given me the confidence, the knowledge and skill to handle this phase two trial at my site.
Additionally, I have developed a PhD research proposal and applied at ITM, Antwerp. ITM and UoG have a collaborative agreement for research and training (CART project) since 2014. My fellowship program have helped me to identify research gaps, formulate research question and develop a proposal.
I am sharing my experience from the fellowship to the UoG staff through trainings on GCP. As a principal investigator I have given GCP trainings for my study team members and staff working in another clinical trial at the site. This training was a very successful and valuable training for the University of Gondar Staffs’ who are involved in doing clinical trial. Within the CART project activities I was giving training on Leishmaniasis for health professionals. Also I continued to publish papers in peer reviewed journals. Apart from giving training recently I have attended a Short course on Clinical Research and Evidence based Medicine (SCREM) at Institute of Tropical Medicine (ITM), Antwerp, Belgium.
I am also making an impact not only by conducting researches but also by assisting in the ethical review process of research proposals submitted to the Institutional Review Board.
In General, In addition to the clinical and research activities that I was conducting in leishmaniasis research and treatment center before the fellowship, I am now a principal investigator for a phase three trial, a lecturer, clinician, potential candidate for PhD program, site PI for phase two trial and independent reviewer for the institutional ethics committee. I strongly believe this is the start of my journey. I will continue to do more and to make an impact on improvement of human health.
At last, I would like to thank my families, friends, my supervisors, my home and host institution, WHO TDR CDF program coordinators and to all who helped me to be in a position that I held now.