Smart phones: calling up apps for new CR uses
New technology works globally
The vanguard of new technology includes multiple uses of mobile phones during the clinical research process. These devices have a penetration that laptops and land lines will never have, and so they are becoming an important tool for use in recruiting and monitoring subjects, an expert says.
Clinical trial recruitment that uses new mobile telephone technology is especially important in many areas of the world where cell phones can be found in four-to-five times as many homes as land phone lines or computers, says Tim Davis, BSc, chief executive officer and co-founder of Exco InTouch Ltd. in London, England.
In resource-poor countries the land line technology is poor, but it has been easier to install mobile phone networks nationwide, so these countries leaped ahead to mobile technology, Davis explains.
"When we do clinical trials in South Africa or Kenya, it’s incredibly simple to use mobile phone networks, which are reliable and easy to work with and can support all different languages across the networks," Davis says.
For example, mobile phones can be used when research participants keep electronic diaries. They can transmit data from home across their phone networks, and a central site can review that information remotely.
"If they have patients in South Africa or China, the information is transmitted across real time across mobile networks, and then the principal investigator can log onto our secure reporting and review that data, taking appropriate action," Davis explains.
"We’re looking at integrating medical devices without a platform, such as glucometers and those kind of devices that could have blue tooth technology associated with them," Davis says. "There could be the ability to connect to those devices so when a patient is at home, you could take a peak flow reading remotely."
Using mobile phone technology, remote research nurses can monitor study participants for problems, such as infections. They can track their temperatures through a transmission across the mobile network in real time and alerting the investigator if there’s a finding that indicates a health problem, he adds.
Another progressive use of new technology is that clinical research organizations can do remote verification of clinical trial site data, says Laurel Bonner, RN, BSN, principal CRA with PPD, a Wilmington, NC-based global clinical research organization.
"You actually see what the site has entered into the system before you get there," she adds. "Another aspect that’s excellent is seeing your old reports and site issues prior to the visit."
A monitor can run the report and let the site know there are issues still outstanding at the site, so the site can address these before the next visit.
With new technology, there is a lot monitors can do prior to a site visit so their time is spent more productively when they do travel to the site, Bonner says.
"Your time can be spent actually doing the source data verification, data entry, looking over the regulatory documentation and investigational product accountability," she explains. "These things you do as a monitor at every visit, and now you have time to do a higher quality review within the time frame you have available."