03003nas a2200253   4500000000100000008004100001260004400042653002200086653002000108653001100128653001600139653002600155100001000181700001500191700001400206700001500220700001300235700001400248700001400262700001200276245010100288856009100389520226900480       2017                            d  bAll India Institute of Medical Sciences10aMobile technology10aData Collection10aAfrica10arural areas10aLow resource settings1 aDam J1 aOnyango KO1 aMidamba B1 aGroosman N1 aHooper N1 aSpector J1 aPillai GC1 aOgutu B00aOpen-source mobile digital platform for clinical trial data collection in low-resource settings.  uhttp://innovations.bmj.com/content/early/2017/01/06/bmjinnov-2016-000164.full.pdf+html3 a<p>Background<br />
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.</p>

<p>Objective<br />
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.</p>

<p>Methods<br />
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.</p>

<p>Results<br />
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.</p>

<p>Discussion and Conclusions<br />
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.</p>