Recent estimates of the extent of adoption of electronic data capture (EDC) systems in clinical trials vary. Published adoption
rates range from 24% of all Phase I to Phase IV trials using EDC,1 with 15% of all newly initiated trials using some form of EDC,2 20% of Phase II and Phase III studies using EDC,3 and no more than 20% of all current clinical trials using EDC.4 Therefore, one can say that around 20% of clinical trials are currently using some form of EDC. What is also clear is that
adoption is increasing.1,5The potential benefits of EDC are plenty: rapid access to trial data, more efficient monitoring, higher quality data due to
real-time edit checks and validation logic, elimination of the need for double data entry, reduced queries, less paper, instantaneous
alerts, and faster time to data lock.6,7 Evidence indicates that EDC can reduce overall trial costs, improve patient recruitment, and improve data quality.7-9
Current practice with EDC technology is to have a user working on a fixed personal computer for data entry and reporting.
This is most likely through a Web interface. However, this approach can interrupt the workflow of a trial. For example, a
fixed computer may not be in the same room where the patient visits will take place. This results in data being collected
on paper CRFs and then entered into the EDC at a later time.
Furthermore, not all visits are at a health care facility. For instance, interviews may be conducted at a patient's residence
or place of work, or a coordinator may have to travel to multiple sites to collect data. In such scenarios, data is collected
on paper and entered into the EDC back at the office. In fact, in many cases the advent of EDC has not eliminated paper in
clinical trials. 
Figure 1. In a typical configuration there is a central database with Web as well as mobile access. Each of the devices may
be used at a different site.
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Adding mobile technology to an EDC system can help reduce the reliance on paper and streamline the workflow even further.
Some types of mobile devices are already in common use in health care settings. A recent systematic review10 estimates that the adoption rate of personal digital assistants (PDAs) in health care settings ranges from 45% to 85%, with
adoption currently at its steepest point of increase. Therefore, many health care professionals are already accustomed to
using PDAs personally and professionally. A systematic review of randomized controlled trials comparing handheld (mobile) devices to pencil and paper methods for data
capture concluded that handheld devices improve the timeliness of data handling and are preferred by the subjects, which could
result in improved adherence to protocols.11 Improved data quality was also reported under certain conditions. Therefore, there is evidence that the general benefits
of EDC extend to mobile devices as well.
The following is an explanation of what mobile technology is, how it can be used in clinical trials, and presents some of
the practical issues that need to be considered when deploying it.
Background on mobile technology
Mobile technology means two things: 1) a mobile device is used to enter and view data, and 2) the device can operate when
disconnected from the network (e.g., a user can still do data entry and reporting). All mobile devices tend to be relatively
small and can be carried around easily. Examples of mobile devices are PDAs (such as Palm and Pocket PC devices), smart phones,
Tablet PCs, and laptops.
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