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Researchers have found that despite an ongoing trend for a decreasing proportion of males being enrolled in antileishmanial therapeutic efficacy trials over time, there are still 1.8 times as many males as females involved in clinical trials. A new systematic review and meta-analysis suggests that existing knowledge on drug efficacy is derived from a study population that is heavily skewed towards adult males. At the same time, substantially less is known about the optimal treatment response in female patients.

Three young girls at a clinic in Asia © Credit: Rama George-Alleyne, World Bank

The study identified 135 clinical treatment trials of visceral leishmaniasis published in the past 40 years enrolling 32,177 patients of whom 21,193 (65.9%) were male and 10,984 (34.1%) female, overwhelmingly from high-burden countries of the Indian subcontinent and Eastern Africa.

Visceral leishmaniasis is a neglected tropical disease that currently has an annual estimated incidence of 50,000 to 90,000 cases in 2019 but the case burden used to be much higher. This drop is mostly the result of the ongoing elimination campaign that begun in the Indian subcontinent in 2005.

The Infectious Diseases Data Observatory (IDDO) is currently working towards collating and standardising datasets from several clinical studies included in this systematic review which could provide a valuable resource to understand if differences in treatment outcomes can be expected and what the underlying factors might be.

The full story is available on the IDDO website

Read the publications: Gender disparity in cases enrolled in clinical trials of visceral leishmaniasis: a systematic review and meta-analysis

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