Human African trypanosomiasis (HAT), known as sleeping sickness, is fatal if left untreated and a most neglected disease in Africa. An estimated 350,000 people are infected in 36 countries, the majority living in Angola, DRC, Uganda, Sudan and RoC. New di agnostics and treatments are urgently needed. Diagnostics require invasive methods and lack sensitivity and specificity. Drugs in use are old, toxic, losing efficacy, and require prolonged therapies. For over forty years, negligible clinical research has been done for new HAT treatments; thus, clinical research infrastructure and professional capacity in disease endemic countries is extremely limited. With new treatments in the pipeline, constraints in clinical evaluation and registration of new interve ntions for HAT must be urgently addressed. In August 2005, DNDi sponsored a regional workshop on HAT Clinical Trial Capacity that brought together endemic country HAT disease specialists and European clinical research and disease experts. This initial me eting resulted in the formation of a regional group who will work together to determine and implement a strategy to create sustainable regional and national clinical trial capacity for HAT. The present proposal seeks specific support for the primary acti vities of this group, which will include: HAT clinical trial methodology development Strengthening & harmonising regulatory practices throughout the region Developing strategies for national policy change Targeted HAT clinical trial capacity stren gthening Implementation will be through north-south and south-south exchange of expertise and best practice, specific training and workshops, and concurrent participation in clinical studies. Support to this project will enable the disease endemic count ries to conduct quality multicenter scale clinical trials in a timely manner with the ultimate aim of getting improved treatments registered and to patients as soon as possible.
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Funding SchemeSSA - Specific Support Action