GLOBHELS-Global helse

Emerging international standards and regulations will in few years require complete electronic systems for management of a vaccine trials. Clinical trials conducted in low-income countries need to have the same level of quality and reliability as comparab le studies conducted in high-income countries. This will require data collection and management systems specifically designed and developed for these settings. Research data in low-resource settings are currently mostly collected on paper forms, a proce ss which is susceptible to errors and inefficiency. The lack of control and compliancy to study protocol is a great challenge. To solve this and related problems we will replace the paper based process with a completely digitalized mobile system for con ducting clinical trials. Researcher and field workers will use handheld computers and directly enter the collected information. This will drastically reduce the logistical challenges related to paper handling and digitalizationThis project will enable res earch institutions in low-income countries to conduct high quality vaccine trials. We will build upon existing projects 1) EpiHandy, a generic electronic open source and free mobile data collection and management system, that is being used for regular studies in low-income countries, 2) R, a widely used and renowned open source statistical analysis tool and 3) Nesstar, a research data publishing system. This will form a complete and integrated electronic data chain from point of collection through t o sharing and publishing of data. The consortium includes TDR/WHO, HandheldsForHealth.org (Linux, Bangalore India), Makerere University Uganda, INDEPTH Network / Malaria Clinical Trial Alliance, NSD, Promise Consortium and 2 faculties at Univ of Bergen . Two currently active trial consortia in Africa will field test the software prototypes along the development process in order to secure usefulness and user-friendlyness.