Background: Concerns exist about whether the allocation of resources in health research is aligned with public health needs, in particular in low-resource settings.

Objectives: We aimed to evaluate the alignment between the effort of health research through the conduct of randomised-controlled trials (RCTs) and health needs attributable to the burden of diseases for all regions and all diseases.

Methods: We grouped countries into 7 epidemiological regions and diseases in 27 groups. We mapped all RCTs registered at the International Clinical Trials Registry Platform started in 2006-2015 to each region and group of diseases. We mapped the burden in 2005 as disability-adjusted life years (DALYs) based on the Global Burden of Diseases 2010 study. Within regions, we identified local research gaps, i.e. groups of diseases for which there is little research as compared to the local burden.

Results: We mapped 117 180 RCTs and 220 million DALYs. In high-income vs. non high-income countries, 130.9 vs. 6.9 RCTs per million DALYs were conducted. We did not identify local research gaps in high-income countries. In sub-Saharan Africa, South Asia and Eastern Europe and Central Asia, we identified local research gaps for the respective major cause of local burden. There were no local research gaps in sub-Saharan Africa for Malaria and HIV, which were the second and third highest causes of burden. We identified few local research gaps in other regions.

Conclusions: Most RCTs were conducted in high-income countries, and their share across groups of diseases was aligned with the burden of those countries. Despite an overall low number of RCTs in non high-income regions, the local research effort was generally aligned with the regional burden except for some major causes of burden.