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The current evidence-base for recommendations on the treatment of cutaneous leishmaniasis (CL) is generally weak. Systematic reviews have pointed to a general lack of standardization of methods for the conduct and analysis of clinical trials of CL, compounded with poor overall quality of several trials. For CL, there is a specific need for methodologies which can be applied generally, while allowing the flexibility needed to cover the diverse forms of the disease. This paper intends to provide clinical investigators with guidance for the design, conduct, analysis and report of clinical trials of treatments for CL, including the definition of measurable, reproducible and clinically-meaningful outcomes. Having unified criteria will help strengthen evidence, optimize investments, and enhance the capacity for high-quality trials. The limited resources available for CL have to be concentrated in clinical studies of excellence that meet international quality standards.

Original publication

DOI

10.1371/journal.pntd.0002130

Type

Journal article

Journal

PLoS neglected tropical diseases

Publication Date

01/2013

Volume

7

Addresses

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (WHO/TDR), Geneva, Switzerland. olliarop@who.int

Keywords

Humans, Leishmaniasis, Cutaneous, Antiprotozoal Agents, Treatment Outcome, Biomedical Research, Research Design, Clinical Trials as Topic, Statistics as Topic