Like it has with most aspects of our lives, the internet has revolutionized the process of capturing and managing data for clinical trials. Electronic data capture (EDC), which has provided a reliable and manageable alternative to paper for the storage of patient data, has begun to shift toward cloud services, significantly expanding researchers’ abilities to share and access clinical data. However, in something of an ironic twist, there are some areas within clinical research for which the internet – or, to be more precise, dependence upon it – serves as a barrier rather than a catalyst. In these areas, one cutting-edge EDC offering, offline data entry, can fill in the gaps in connectivity that could otherwise keep researchers from reaping the full benefits of modern data capture technology.
A product of eSource technology, offline data entry allows researchers to capture data on a mobile application, such as a tablet, even in the absence of an internet connection. The data then automatically syncs with an EDC when connectivity is restored. What kinds of researchers stand to benefit the most from offline data entry, and how does it serve their needs?
Where connectivity is an issue, and why it matters
One may expect that, a decade-plus into the 21st Century, internet access in the developed world is all but a given. The reality, though, may come as a surprise. Last year, the FCC reported that a full 53% of the population of rural areas in the United States lacks high-speed internet access1, creating severe limitations for clinical research in those areas. The problem becomes even more acute beyond U.S. shores. In places like India and other developing countries considered hubs of clinical research, internet connectivity is by no means taken for granted. And as outsourcing of clinical research services across international borders increases in prevalence, these concerns will only become more relevant.
For researchers in such areas who depend on the internet for their EDC, this creates a real problem. Insufficient or unreliable internet access poses a threat to timelines and data integrity. A slow connection can delay data entry; a spotty one can put data at risk of being lost. Offline data entry eliminates these threats. The ability to continue the conduct of a trial – not to mention the peace of mind that comes from knowing that entered data is safe – in the event of a lapse in connectivity can make an enormous difference in productivity for researchers working in these areas.
Offline data entry can also help researchers capitalize on an emerging practice taking clinical trials beyond the clinic. Home visits, wherein data is collected at the patients’ homes instead of at a clinical trial site, is a manifestation of the industry-wide trend toward patient engagement – especially as it pertains to patient recruitment. One of the most formidable obstacles recruiters face is the travel burden: the inconvenience, for subjects, of traveling to trial sites is a strong deterrent from enrollment.2 And just as rural areas pose a particular risk of insufficient internet access, they pose a particular risk of presenting this deterrent, as they require, of patients, longer travel times than other areas. Home visits address this challenge; offline data entry makes them practical in the places where they may be the most beneficial.
Offline data entry for animal health
Perhaps the most value for offline data entry lies in animal health research. While clinical trials on companion animals often take place in the clinic, production animals are usually studied out in fields and other remote areas where internet connectivity is sparse at best. The inability to depend on the internet in such circumstances could create an aversion to internet-based tools, possibly explaining why EDC adoption has been slower in animal health than in other areas of clinical research. The capacity for offline data entry can be reassuring for a sector with understandable reservations about data management procedures that require an internet connection. And as current environmental and agricultural conditions lend significant growth potential to animal health research, that resource may become even more valuable.
The difference that the internet has made in catalyzing clinical research is inestimable. But as clinical research continues to be outsourced to regions where internet connectivity is not a given, many researchers are not yet able to fully reap the benefits of this technological revolution. Offline data entry addresses this disparity. Ideally, there will come a day when internet access is truly universal; in the meantime, offline data entry levels the playing field.
1 Garner, Rochelle; President Obama presses for high-speed Internet for rural Americans; CNET; 13 January 2015;
2 Kim, SH; Tanner, A; Friendman, DB; Foster, C; Bergeron, CD; Barriers to clinical trial participation, a comparison of rural and urban communities in South Carolina; National Center for Biotechnology Information; June 2014