Methodology of Clinical Trials Aimed at Assessing Interventions for Cutaneous Leishmaniasis

Piero Olliaro*, Michel Vaillant, Byron Arana, Max Grogl, Farrokh Modabber, Alan Magill, Olivier Lapujade, Pierre Buffet, Jorge Alvar

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

76 Citations (Scopus)

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.

Original languageEnglish
Article numbere2130
JournalPLoS Neglected Tropical Diseases
Volume7
Issue number3
DOIs
Publication statusPublished - 2013

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