title: Methodology of clinical trials aimed at assessing interventions for cutaneous leishmaniasis.
abstract: 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.
authors.affiliation: UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (WHO/TDR), Geneva, Switzerland. olliarop@who.int
authors.forename: Piero
authors.initials: P
authors.lastname: Olliaro
authors.forename: Michel
authors.initials: M
authors.lastname: Vaillant
authors.forename: Byron
authors.initials: B
authors.lastname: Arana
authors.forename: Max
authors.initials: M
authors.lastname: Grogl
authors.forename: Farrokh
authors.initials: F
authors.lastname: Modabber
authors.forename: Alan
authors.initials: A
authors.lastname: Magill
authors.forename: Olivier
authors.initials: O
authors.lastname: Lapujade
authors.forename: Pierre
authors.initials: P
authors.lastname: Buffet
authors.forename: Jorge
authors.initials: J
authors.lastname: Alvar
mesh_terms: D000981:Antiprotozoal Agents / Q000627:therapeutic use*; D035843:Biomedical Research / Q000379:methods* / Q000592:standards; D002986:Clinical Trials as Topic; D006801:Humans; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy*; D012107:Research Design / Q000592:standards; D013223:Statistics as Topic / Q000592:standards; D016896:Treatment Outcome
chemical_list: D000981:Antiprotozoal Agents
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