Data collection and pregnancy registries: How PROTECT is strengthening the clinical trials infrastructure in Africa
Globally, only a fraction of clinical trials are conducted in Africa. The reasons for this are varied and include limited funding, inadequate research infrastructure, and a lack of trained personnel. PROTECT aims to tackle these barriers and demonstrate how low- and middle-income countries can set up electronic health records, collect quality data, and eventually take part in clinical trials.
PROTECT partners are supporting hospital sites in Kenya, Malawi, Mozambique, and Uganda to establish pregnancy registries, which will generate longitudinal data on pregnancies, deliveries, and infant follow-up for maternal vaccine safety assessment and generating comparable essential data across the four countries on adverse pregnancy, neonatal and infant outcomes using consensus definitions for maternal vaccine safety assessment. More than a year into the project, the researchers have now mapped out the current capacities in the four project countries and are working with national and local authorities to build on existing data collection processes and set up uniform registries.
PROTECT meetings with the Ministry of Health in Uganda.
Despite the different systems currently in place, PROTECT researchers are supporting the selected hospitals to develop pregnancy registries that will facilitate the estimation of baseline rates of pregnancy and neonatal Adverse Events Following Immunisation (AEFI)/Adverse Events of Special Interest (AESI) using consensus definitions for maternal vaccine safety assessment. In the future, these hospitals will be able to conduct maternal vaccine trials, while the example of the PROTECT data collection framework could be used to strengthen data collection capacity in other medical facilities around the world.
If you’re interested in finding out more about this work, watch the interview with Gordon Rukundo, who leads the work on setting up pregnancy registries in PROTECT:
