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Health IT, systems and process innovations
Original article
Open-source mobile digital platform for clinical trial data collection in low-resource settings
  1. Joris van Dam1,
  2. Kevin Omondi Onyango2,
  3. Brian Midamba2,
  4. Nele Groosman3,
  5. Norman Hooper3,
  6. Jonathan Spector1,
  7. Goonaseelan (Colin) Pillai4,
  8. Bernhards Ogutu2
  1. 1Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA
  2. 2Kenya Medical Research Institutes and Center for Research in Therapeutic Sciences Strathmore University, Nairobi, Kenya
  3. 3Dimagi, Cape Town, South Africa
  4. 4Novartis AG, Basel, Switzerland
  1. Correspondence to Joris van Dam, Novartis Institutes for BioMedical Research, 250 Massachussetts Ave, Cambridge, Massachusetts 02139-4133, USA; joris.vandam{at}novartis.com

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.

Discussion and 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.

  • mHealth
  • Global Health
  • Reverse Innovations
  • clinical research
  • eSource

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjinnov-2016-000164

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    Footnotes

    • Contributors JvD, KOO, NH, JS, GP and BO were involved in conception or design of the work. KOO, BM, NG, NH and BO collected the data. KOO, BM, NG, NH and GP analysed and interpreted the data. JvD, KOO, BM, NG and NH drafted the article. JS, GP and BO critically revised the article. JvD, KOO, BM, NG, NH, JS, GP and BO approved the final version of the article to be published.

    • Funding Novartis Institutes for BioMedical Research, Investigator Initiated Trial Agreement, dated October 2014.

    • Competing interests NG and NH are employees of Dimagi , the company that developed the CommCare platform. JvD, JS and CP are employees of Novartis.

    • Ethics approval KEMRI SERU (Scientific and Ethics Review Unit).

    • Provenance and peer review Not commissioned; externally peer reviewed.