Experience of using an open source clinical trials data management software system in Kenya

Area of Science:

• Clinical Research
• Health Informatics
• Open-Source Software

Background:

• Clinical trials data management (CTDM) is challenging in resource-poor settings due to insufficient resources and poor internet connectivity.
• Open-source software presents a viable solution for overcoming these CTDM hurdles.

Purpose of the Study:

• To evaluate the effectiveness of OpenClinica, an open-source software, for clinical trials data management in resource-poor environments.
• To share experiences and lessons learned from adopting and implementing OpenClinica at the KEMRI-Wellcome Trust Research Programme (KWTRP).

Main Methods:

• Adoption and implementation of OpenClinica community edition since 2007 at KWTRP.
• Utilized OpenClinica in three distinct data entry modes: direct remote entry, centralized data entry, and offline data entry.
• Applied OpenClinica across eleven trials/studies involving over 6000 participants in East Africa.

Main Results:

• Successfully managed data for large, complex multi-site trials in East Africa using OpenClinica.
• Developed significant local capacity in clinical trials data management through hands-on training and mentorship.
• Initiated sharing of developed expertise with other regional institutions.

Conclusions:

• Open-source data management systems, like OpenClinica, are effective for managing clinical trial data to international standards in resource-poor countries.
• Successful implementation demonstrates the potential for sustainable and high-quality CTDM in challenging settings.