Using mobile tools in clinical trials offers a long list of benefits, from helping patients stay on medication routines to the ability to change gears quickly, but mHealth is also a double-edged sword as data collection and deeper insight could propel trials off course, according to a report at Hospital & Health Networks.
Mobile tech can gather data from trial subjects anywhere and anytime, allow researchers to remotely interact with patients and boost communication, monitor trial compliance and help keep trial participants involved.
"The promise of adding new technology, especially informatics and mobile devices, is right now viewed as [an advance] that could dramatically change the way clinical trials are run," Rob Franco, a principal with consulting firm PricewaterhouseCoopers, told Hospital & Health Networks.
Yet not everyone in the clinical trial environment is ready to embrace mHealth, especially given the millions involved and concerns regarding data collection and development of new theories that can deride a trial.
"There's a basic, high-level, somewhat unspoken premise about regulatory trials, which is, 'Ask the questions you need to, don't ask the questions you don't need to.' Because the goal is to get approved, right?" Donald Jones, chief digital officer of Scripps Translational Science Institute, said in the article. "When you use devices that collect a lot of data, it opens the possibility that it might raise more questions."
Remote monitoring is nothing new within the healthcare sector as it's proven to be viable, cost-effective and beneficial. A telemedicine platform developed for the Mayo Clinic and Mayo Clinic Health System will provide patients with real-time interactive communication with healthcare providers using high-definition videoconferencing. In early September Scripps Health initiated a 60-day software pilot that delivers critical-care patient monitoring data from multiple systems to mobile devices used by doctors in and out of the hospital setting.
AMC Health, in New York City, is not deterred by some of the cons and is running five trials that incorporate remote monitoring, according to the HHN report. The goal is to assess how mHealth can help recruit trial participants, keep participants engaged and monitor patient adherence to trial protocol.
"The problem in most trials is that you don't know when there's non-adherence," John Holland, AMC Health senior vice president for research and business development, said in the article. The ability to remotely monitor patient involvement aids in compliance, drives more substantive results and saves time and money.
"Delays are extremely costly. So, if you can make it easier for patients, you're more likely to keep them enrolled," Holland said.
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