Non-commercial clinical research in neglected tropical diseases

Around one billion of the world’s poorest and most marginalized people suffer from neglected tropical diseases (NTDs), i.e. a group of chronic parasitic and related bacterial and viral infections that “promotes poverty” because of their impact on child development, pregnancy outcome, and work productivity. Despite tremendous progress over the past decade, India has the highest burden of NTDs in the world. Also Bangladesh has a huge burden of NTDs, particularly for Kala-azar, Lymphatic Filariasis and helminths. Globally only around 1% of R&D cost is spent on developing new drugs in NTDsi . Therefore, much more clinical research is needed in this field. Because of NTDs’ specificities, such clinical trials must be conducted at research-naïve, remote settings in low- and middle-income countries (LMICs), where achieving Good Clinical Practice (GCP)-compliance and ethically soundness may be very challengingii. This is true also in the specific context of research in NTDs in India and Bangladesh, where there is a great need to create or strengthen clinical research infrastructures and capacities, in order (a) to facilitate the conduct of GCP-compliant, ethically sound clinical trials addressing the health needs of local communities and (b) to generate sustainable local capacity to conduct independent research that has a reasonable likelihood to deliver products that become available to all those in need. Unfortunately, very few trials have been conducted up to now in the Indian and Bangladesh government sector at district or primary health care level, which are the only settings where the new NTDs treatments’ feasibility can be demonstrated (“real-life settings”). In addition, the impact on NTDs research of the complex regulatory and legal structure in these two countries has not (to the best of our knowledge) been assessed yet. This project will therefore aim at addressing this complex set of problems by conducting two clinical trials, at clinical sites in the public health sector in India and Bangladesh, in order to deliver improved and affordable treatments for visceral leishmaniasisiii,iv,v; generating new knowledge from these two clinical trials about the optimal approach to implementation of GCP when working in “real-life settings” and with socially vulnerable communities; and analyzing the local regulatory and legal factors that may hinder or favor future research in NTDs within public health sector in India and Bangladesh. In other words, we will attempt to generate new knowledge centered around the work of clinical trials, but not limited to the clinical trial’s results: we will also explore innovative approaches to conduct GCP-compliant clinical trials in limited resource settings and we will investigate the local regulatory challenges. It is hoped that this project will allow to develop a replicable model, applicable in other NTDs clinical research settings.

Trefwoorden:B680-epidemiologie