The introduction of mobile device-based electronic data capture system (mEDC) technology is indeed a boon for clinical trials, as per a research report. According to the new research paper published by the Journal of Medical Internet Research, the mobile device is of immense help in terms of supporting a slew of services within clinical trials such as project management, tele-monitoring, and data management, among others.
A mobile device-based electronic data capture system (mEDC) has been developed by the research at the George Institute of Global Health, Peking University Health Science Centre. The doctors, with little experience, are being able to use the electronic data capture systems (EDC) with much ease and navigate the duties of clinical trial management.
Zhang et al wrote in the research paper, "The significant and specific features of mEDC include data collection, monitoring, and project management in real time. Although computer-based trials proposed that they could recruit patients and collect data in real time by using the Internet, in most cases, doctors were more likely to rely on transferring data by means of paper-to-computer when they captured clinical data, particularly in trials wherein data sources involved health records.”
According to the paper, the EDCs are gaining traction for clinical trial use. Zhang noted that few phases of clinical trial lacked real-time data collection that could provide potentially critical insights.
Put on the clinical trial to patients with mild to moderate hypertension (who were not on medication), the study found mEDC were a resounding success. Around 14 hospitals already have the mEDC that has accurately captured the data of 1,037 of the 1,333 patients. The patients were asked to visit four hospitals and re-submit their data successfully to get the “Complete” mark. To complete 144 data entry questions under the mEDC, across all visits, the average time it took a patient was just 53 minutes. Both the patients and doctors termed it as an acceptable amount of time.
The satisfaction quotient among those interviewed who used mEDC included 24 doctors, 53 patients, and a clinical research associate, a project manager and a data manager were 9.2 out of 10. The mECD’s have immense potential to manage and coordinate higher-phase clinical trials due to the exceptional user-friendliness for the stakeholders in a clinical trial.
“The mobile device-based data capture and project management system, mEDC, could help doctors complete a phase IV pharmaceutical clinical trial and were feasible for the management of this trial. Furthermore, doctors expressed their willingness to use this tool for study implementation. The validity, reliability, real-time feature, and user friendliness of mEDC are beneficial not only for doctors without clinical trial experience but also for CRAs and PMs. Taken together, there is a possibility for mEDC to be used in other pharmaceutical clinical trials in the future”, Zhang noted.
Areas of concern
The researchers felt the maintenance and stability of Wi-Fi or mobile network that connected mEDC tools as main areas of concern, as it is operated through smart phones, the reliability of an Internet connection are crucial.
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