ArticleBMC research notes2014
Experience of using an open source clinical trials data management software system in Kenya.
Article in BMC research notes, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed.
- The Development of a Clinical Registry Digital Database on Invasive Fungal Infections in India: Advancing Epidemiological Understanding and Patient Care.Journal of fungi (Basel, Switzerland) · 2024Article
- Data management system for diabetes clinical trials: a pre-post evaluation study.BMC medical informatics and decision making · 2023Article
- StudyU: A Platform for Designing and Conducting Innovative Digital N-of-1 Trials.Journal of medical Internet research · 2022Article
- Article
- A Clinical Data Management System for Diabetes Clinical Trials.Journal of healthcare engineering · 2022Article
- An Open-Source, Standard-Compliant, and Mobile Electronic Data Capture System for Medical Research (OpenEDC): Design and Evaluation Study.JMIR medical informatics · 2021Article
- Issues, challenges, and the way forward in conducting clinical trials among neonates: investigators' perspective.Journal of perinatology : official journal of the California Perinatal Association · 2019Article
- Use of the data system for field management of a clinical study conducted in Kolkata, India.BMC research notes · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundClinical 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.
findingsIn 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.
conclusionsOur experience demonstrates that an open source data management system to manage trials' data can be utilized to international industry standards in resource-poor countries.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.