An improved understanding of the clinical outcomes of VL treatment could be obtained through creation of a central data repository populated with individual patient data (IPD) from clinical trials or programmatic data. By bringing together available data we can maximise the utility of existing resources to address priority questions in VL treatment and create a framework to assemble future studies, guide best practice in data collection and optimise the efficiency of research design and therapeutic selection. A repository of IPD from VL clinical trials or programmatic data could serve two primary functions:
- Provide an accessible, comprehensive and up-to-date archive of VL clinical trials, describing the protocols, methods, patient populations and outcomes of each trial. This resource would be valuable to clinicians, drug developers and healthcare policy makers, helping to improve the efficacy of VL treatments and regimens in specific regions or populations. This would also guide the design of future trials of drugs under development and improve consistency in trial outcomes. This resource could be expanded to programmatic data if deemed useful by the VL scientific community.
- Enable detailed pooled analyses to compare treatment outcomes in specific regions and sub-groups of patients. These analyses could provide a better understanding of the determinants of treatment efficacy and identify sub-populations at particular risk of treatment failure due to factors such as age, geographic origin, or coinfection.
We are currently consulting with stakeholders to develop a research agenda with a set of questions that are both important to the VL research community, and answerable with the data currently available. Once a draft agenda is available, we will display it on this page for comments and suggestions.