Antivenom Clinical Methodology Development

There is a desperate lack of quality assured antivenoms for use in Africa. Many antivenoms in current use have undergone only limited pre-clinical testing and have never had formal clinical evaluation. To address this problem, a substantial clinical evaluation programme of antivenoms will be needed. Clinical trials of antivenom are challenging. A number of factors including multiple species, multiple different antivenoms, heterogeneity of clinical manifestations, need for studies in different geographical locations and lack of clear endpoints have all contributed to a dearth of trials. This proposal is to undertake the preliminary work necessary for the establishment of a major antivenom clinical trial network. Following a review of existing studies and methodologies to inform the discussion, a workshop will bring methodology and snakebite experts together. Expected workshop outputs will be as follows: a) Preliminary identification of suitable sites b) Priorities for antivenom testing c) Agreed endpoints for clinical trials of a variety of species d) Agreed methodologies, including potential adaptive designs for rapid assessment of new antivenoms.