Recommendations of the Informal Consultation on issues for clinical product development for Human African Trypanosomiasis

Document produced by: Innovative and Intensified Disease Management (IDM), Department of Control of Neglected Diseases (NTD), WHO

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Publication details

Publication date: 1 January 2007
Number of pages: 78
Languages: English

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Summary

Researchers involved in clinical trials for the evaluation or development of new treatment modalities for human African trypanosomiasis (HAT), also known as "sleeping sickness," convened in an Informal Consultation to review and discuss available data, and to develop a consensus framework for planning, conducting and analysis of clinical trials.

The recommendations of the Informal Consultation were driven by the need for an evaluation of the efficacy of new treatment regimes, but are in most cases either directly applicable or easily adaptable to the evaluation of new diagnostics. They focused on the acquisition of data from clinical trials.

The Consultation also discussed the need for comparability of published data on drug efficacy, and made recommendations for the analysis and reporting of drug efficacy of treatment regimens under evaluation.