title: Open-source mobile digital platform for clinical trial data collection in low-resource settings.
abstract: BACKGROUND
  Governments, universities 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 used in the developing world with an open-source, standard platform for electronic data capture in clinical trials. The integration was developed using common data standards (Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model), maximising 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. Multidisciplinary 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Novartis Institutes for BioMedical Research Inc , Cambridge, Massachusetts , USA.
authors.forename: Joris
authors.initials: J
authors.lastname: van Dam
authors.affiliation: Kenya Medical Research Institutes and Center for Research in Therapeutic Sciences Strathmore University , Nairobi , Kenya.
authors.forename: Kevin
authors.initials: K
authors.lastname: Omondi Onyango
authors.affiliation: Kenya Medical Research Institutes and Center for Research in Therapeutic Sciences Strathmore University , Nairobi , Kenya.
authors.forename: Brian
authors.initials: B
authors.lastname: Midamba
authors.affiliation: Dimagi , Cape Town , South Africa.
authors.forename: Nele
authors.initials: N
authors.lastname: Groosman
authors.affiliation: Dimagi , Cape Town , South Africa.
authors.forename: Norman
authors.initials: N
authors.lastname: Hooper
authors.affiliation: Novartis Institutes for BioMedical Research Inc , Cambridge, Massachusetts , USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Spector
authors.affiliation: Novartis AG , Basel , Switzerland.
authors.forename: Goonaseelan Colin
authors.initials: GC
authors.lastname: Pillai
authors.affiliation: Kenya Medical Research Institutes and Center for Research in Therapeutic Sciences Strathmore University , Nairobi , Kenya.
authors.forename: Bernhards
authors.initials: B
authors.lastname: Ogutu
keywords: Global Health; Reverse Innovations; clinical research; eSource; mHealth