Drugs for Neglected Diseases initiative

The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit medical research organisation that discovers, develops, and delivers safe, effective, and affordable treatments for neglected people. DNDi is developing medicines for sleeping sickness, leishmaniasis, Chagas disease, river blindness, mycetoma, dengue, paediatric HIV, advanced HIV disease, cryptococcal meningitis, and hepatitis C. Its research priorities include children’s health, gender equity and gender-responsive R&D, and diseases impacted by climate change. Since its creation in 2003, DNDi has joined with public and private partners across the globe to deliver twelve new treatments, saving millions of lives.

Role within eWHORM

In eWHORM, DNDi will lead work related to the master trial protocol and the shared database. Together with partners, DNDi will develop an adaptive basket trial master protocol that will include product characteristics, available pre-clinical and clinical data, drug-drug interactions, and a dose rationale. DNDi will also prepare the documents for the European Medicines Agency protocol/scientific advice procedures. In a second work package led by DNDi, our office in Kenya will be the lead partner to develop, implement, and maintain study-specific data management documents. This will include database set-up and validation, performing data management activities, and performing CDISC data transformation.