Methodology of clinical trials aimed at assessing interventions for cutaneous leishmaniasis

PLoS Negl Trop Dis. 2013;7(3):e2130. doi: 10.1371/journal.pntd.0002130. Epub 2013 Mar 21.

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.

MeSH terms

  • Antiprotozoal Agents / therapeutic use*
  • Biomedical Research / methods*
  • Biomedical Research / standards
  • Clinical Trials as Topic
  • Humans
  • Leishmaniasis, Cutaneous / drug therapy*
  • Research Design / standards
  • Statistics as Topic / standards
  • Treatment Outcome

Substances

  • Antiprotozoal Agents

Grant support

The authors have indicated that no funding was received for this work.