Pooling patient data could improve VL treatment options

TDR news item
12 September 2017

The findings of a systematic literature review, published in PLOS Neglected Tropical Diseases, suggest that that there is sufficient data to justify a dedicated data platform on visceral leishmaniasis clinical trials. Combining patient data would give scientists and clinicians more tools to understand and treat the disease which can be fatal if untreated.

Credit: Anita Khemka/DNDi

VL affects the most vulnerable populations in areas of Africa, Asia, South America and the Mediterranean Basin. The disease is caused by protozoan parasites transmitted by sand flies. The few treatment options that exist are often expensive, poorly adapted for use in the field or have life-threatening toxicity. Consequently, clinicians and researchers have identified a significant need for effective, safe, affordable treatments, in addition to methods of detecting the emergence of drug resistance.

The need for systematic reviews of trial data to summarise clinical trial results and improve consistency in trial design has been highlighted by the World Health Organization. However, VL clinical trial reports typically release only summary statistics rather than individual patient data (IPD), making comparison of efficacy between drugs and regions challenging.

Numerous factors affect the efficacy of VL treatments and the risk of resistance, including geographical area, malnourishment and HIV co-infection. “Establishing a workable database of VL patient information could transform the way we understand, diagnose and treat the disease,” said Prof Philippe Guérin, the senior author of the paper and director of the Infectious Diseases Data Observatory.

Authors include physicians and scientists from the University of Oxford, Drugs for Neglected Diseases initiative, and TDR.

The review identified 145 VL clinical trials conducted in the last three decades. Those trials have enrolled nearly 27,000 patients, the majority in the last 15 years.

More information on the review is available at the Infectious Diseases Data Observatory .

For more information, contact:
Jamie Guth
TDR Communications Manager
Telephone: +41 79 441 2289
E-mail: guthj@who.int.

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