Ethics & Engagement across the Wellcome Trust Major Overseas Programmes
I am writing a paper on the development of drugs for severe malaria in children.
Although important progress has been made during the last decade, severe falciparum malaria remains a major cause of mortality, especially in children under five in sub-Saharan Africa. Even with the current first line treatment, parenteral artesunate, mortality remains high at around 10%. It is clear that new drugs are needed. Artesunate was first evaluated in healthy volunteers for safety and pharmacokinetic properties, followed by safety and pharmacokinetic studies in adults with uncomplicated malaria, then mortality studies in adults with severe malaria, and finally mortality studies in children with severe malaria. In sub-Saharan Africa, where malaria transmission is high, severe malaria is a pediatric disease, and malaria is declining in almost all Asian countries. This means that large trials in adults with severe malaria and mortality as the primary endpoint are becoming increasingly difficult.
My paper will focus on the ethical and practical issues of the development of drugs for severe malaria in children, and will propose an alternative research pathway.
Hope to get in done soon.
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