The development of a global research agenda and individual participant data platform for visceral leishmaniasis: challenges and future opportunities

Abstract

Background: Visceral leishmaniasis (VL) is one of the neglected tropical diseases (NTDs) listed by the World Health Organization (WHO). The disease is currently in the elimination phase in the Indian subcontinent (ISC) and being targeted for elimination by 2030 in East Africa (EA). Maintaining the necessary financial and political commitments to achieve and sustain the current elimination efforts remains challenging. As with other NTDs, VL research is constrained by limited funding, and drug development has relied largely on partnerships between not-for-profit organisations and the pharmaceutical industry. Conducting robust clinical studies remains difficult, and therapeutic innovations have been limited. However, re-use of existing data offers an untapped opportunity to generate new evidence. Methods: We describe the process of developing a global VL research agenda and the establishment of an individual participant data (IPD) platform at the Infectious Diseases Data Observatory (IDDO). Key steps included a systematic scoping review of VL clinical trials, consultations with the Scientific Advisory Committee, expert and public reviews, and implementation of an equitable governance framework to harmonise and share IPD. Results: The VL research agenda, finalised in 2019, identified priority methodological and clinical questions suited to IPD analyses. The IDDO VL platform currently hosts harmonised data from nearly 15,000 patients across more than 50 studies (VL and post-kala-azar dermal leishmaniasis, PKDL). The platform is an inclusive resource guided by an equitable governance framework and provides a critical asset to support new evidence generation and can serve as a historical data to support accelerated drug development. Conclusions: The development of a global VL research agenda has provided an inventory of priority research questions of public health importance. A shared IPD platform aligned with this agenda was developed to complement ongoing global efforts. In addition, such a platform can accelerate secondary evidence generation, support methodological innovation and inform future trial designs and policy. Sustained collaboration and investment are needed to maximise the scientific and public health value of data re-use in VL and PKDL. © The Author(s) 2025.