Individual Study / van Dam et al.; BMJ Innov. 2017

Open-source Mobile Digital Platform for Clinical Trial Data Collection in Low-Resource Settings

Open-source Mobile Digital Platform for Clinical Trial Data Collection in Low-Resource Settings

Initiatives -
The 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. Note: All published information has been collected from the article referenced in the Marker Paper box below. Therefore, there may be variations with more advanced versions of the study.
Start Year
2017
Funding
Novartis Institutes for BioMedical Research,Investigator Initiated Trial Agreement, dated October 2014.

Design

Study design
Clinical trial cohort

Marker Paper

van Dam J, Omondi Onyango K, Midamba B, et al. Open-source mobile digital platform for clinical trial data collection in low-resource settings. BMJ Innov. 2017;3(1):26‐31. doi:10.1136/bmjinnov-2016-000164

PUBMED 28250964

Number of participants

Number of participants
54
Number of participants with biosamples

Access

Availability of data and biosamples

Data
Biosamples
Other

Timeline

Population

The study involving healthy human volunteers.
Selection Criteria
Newborns
Twins
Countries
  • Kenya
Territory
Nairobi
Ethnic Origin
Health Status

Recruitment

Number of participants

Number of participants
54
Number of participants with biosamples
Data Collection Event
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.
Start Date
2017
End Date
2017
Data sources
  • Mobile data collection
    • Smartphone apps