An open-source mobile digital platform for clinical trial data collection in low-resource settings

Background Governments and pan-African research networks are building durable infrastructure and capabilities for biomedical research in Africa. This offers the opportunity to adopt from the outset innovative approaches and technologies that would be challenging to retrofit into fully established research infrastructures such as those regularly found in high-income countries. In this context we piloted the use of a novel mobile digital health platform, designed specifically for low resource environments, to support high quality data collection in a clinical research study. Objective Our primary aim was to assess the feasibility of a using a mobile digital platform for clinical trial data collection in a low resource setting. Secondarily, we sought to explore the potential benefits of such an approach. Methods The investigative site was a research institute in Nairobi, Kenya. We integrated an open-source platform for mobile data collection commonly utilized in the developing world with an open-source, standard platform for Electronic Data Capture (EDC) in clinical trials. The integration was developed using common data standards (CDISC ODM), maximizing the potential to extend the approach to other platforms. The system was deployed in a pharmacokinetic study involving healthy human volunteers. Results The electronic data collection platform successfully supported conduct of the study. Multi-disciplinary users reported high levels of satisfaction with the mobile application and highlighted substantial advantages when compared with traditional paper record systems. The new system also demonstrated a potential for expediting data quality review. Discussion and Conclusion This pilot study demonstrated the feasibility of using a mobile digital platform for clinical research data collection in low resource settings. Sustainable scientific capabilities and infrastructure are essential to attract and support clinical research studies. Since many research structures in Africa are being developed anew, stakeholders should consider implementing innovative technologies and approaches