Clinical trial data management in environmental health tailored for an African setting

Abstract

Clinical trial data management tools are widely available—some free to access and others relatively expensive, particularly for low- and middle-income countries. Such tools also do not always permit adaptation for local conditions nor include options to capture environmental and meteorological data. In the context of climate change and pressing environmental health threats, more studies that aim to assess the impacts of environmental change on public health are being carried out. Here, using freely available software, we tailor-made a clinical trial data management tool that managed all aspects of an intervention-based clinical trial to assess the impact of personal solar ultraviolet radiation exposure on vaccine e ectiveness. Data captured and associated procedures included patient data, scheduling, reporting, analysis and data management. Moreover, patient enrolment, recruitment, follow-up and decision-making in response to patient data were managed. Given the multidisciplinary study approach, the tool also managed all environmental and meteorological data for the rural African study site. Application of the tool ensured e cient communication between rural sites, a relatively high overall participant response rate (87%) and minimal loss to follow-up. This study suggests that it is possible to tailor-make a clinical trial data management tool for environmental and public health studies.