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

BMC Research Notes

Greg Fegan¹  Trudie Lang¹  Patricia Njuguna²  Roma Chilengi³  Naomi Waithira²  Moses M Ngari² 

[1]Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, UK

[2]KEMRI-Wellcome Trust Research Programme, Centre for Geographic Medical, Research Coast, PO Box 230, Kilifi 80108, Kenya

[3]Center for Infectious Disease Research, Lusaka, Zambia

关键词: OpenClinica;    Open-source systems;    Data management;    Clinical trials;   

Others  :  1118204
DOI  :  10.1186/1756-0500-7-845

 received in 2014-04-30, accepted in 2014-11-18,  发布年份 2014

【 摘 要 】

Background

Clinical trials data management (CTDM) remains one of the many challenges in running state of the art trials in resource-poor settings since most trials do not allocate, or have available, sufficient resources for CTDM and because of poor internet connectivity. Open-source software like OpenClinica could be a solution in such scenarios.

Findings

In 2007, the KEMRI-Wellcome Trust Research Programme (KWTRP) adopted OpenClinica (OC) community edition, an open-source software system and we share our experience and lessons learnt since its adoption. We have used OC in three different modes; direct remote data entry from sites through Global System for Mobile Communications (GSM) modems, a centralized data centre approach where all data from paper records were entered at a central location and an off-line approach where data entry was done from a copy of database hosted on a field-site server laptop, then data uploaded to a centralized server later. We have used OC in eleven trials/studies with a cumulative number of participants in excess of 6000. These include large and complex trials, with multiple sites recruiting in different regions of East Africa. In the process, we have developed substantial local capacity through hands-on training and mentorship, which we have now begun to share with other institutions in the region.

Conclusions

Our experience demonstrates that an open source data management system to manage trials’ data can be utilized to international industry standards in resource-poor countries.

【 授权许可】

   
2014 Ngari et al.; licensee BioMed Central Ltd.

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