Current Pipelines for Neglected Diseases.

This paper scrutinises pipelines for Neglected Diseases (NDs), through freely accessible and at-least-weekly updated trials databases. It updates to 2012 data provided by recent publications, and integrates these analyses with information on location of trials coordinators and patients recruitment status. Additionally, it provides (i) disease-specific information to better understand the rational of investments in NDs, (ii) yearly data, to understand the investment trends. The search identified 650 clinical studies. Leishmaniasis, Arbovirus infection, and Dengue are the top three diseases by number of clinical studies. Disease diffusion risk seems to be the most important driver of the clinical trials target choice, whereas the role played by disease prevalence and unmet need is controversial. Number of trials is stable between 2005 and 2010, with an increase in the last two years. Patient recruitment was completed for most studies (57.6%), and Phases II and III account for 35% and 28% of trials, respectively. The primary purpose of clinical investigations is prevention (49.3%), especially for infectious diseases with mosquitoes and sand flies as the vector, and treatment (43.2%), which is the primary target for parasitic diseases Research centres and public organisations are the most important clinical studies sponsors (58.9%), followed by the pharmaceutical industry (24.1%), foundations and non-governmental organisations (9.3%). Many coordinator centres are located in less affluent countries (43.7%), whereas OECD countries and BRICS account for 34.7% and 17.5% of trials, respectively. Information was partially missing for some parameters. Notwithstanding, and despite its descriptive nature, this research has enhanced the evidence of the literature on pipelines for NDs. Future contributions may further investigate whether trials metrics are consistent with the characteristics of the interested countries and the explicative variables of trials location, target (disease) choice, and the object of the trials. Author Summary: Neglected diseases lead to illness, long-term disability and affect economic development in poor populations. There is evidence that clinical research on neglected diseases has increased starting from the second half of the '90s. This paper aims at updating this evidence to 2012 and at integrating available data (groups of target of the clinical projects, phase in the clinical development process, sponsors) with other data that have not been investigated or published so far (recruitment status of patients, and trials location of the trials coordinator). Our study has confirmed previous findings on the important investment in NDs, highlighting, thanks to a disease-specific approach, a particular focus on diseases with a higher diffusion risk, but not necessarily the higher prevalence and the most unmet need. In most studies, patients' recruitment has been completed, and many trials are also in the very terminal phases: this means a high probability that new treatments will be available in the next years. In addition, trial coordinator centres are increasingly located in low income countries; as a consequence, the investment in clinical research has become an opportunity to further enhance clinical and organisational expertise in these countries. [ABSTRACT FROM AUTHOR]