Nov. 13, 2007 | At the University of Maryland Medical Center, the Greenebaum Cancer Center views telemedicine conferences as occasions to remind community-based physicians of clinical trial options and the particulars of the enrollment process, says Mohan Suntha, vice chairman of the center’s department of radiation oncology.
The same trial treatment options available at the University of Maryland are available at four affiliated community hospitals where university-employed clinical research associates have been placed, says Suntha. Over the past several years, 25 percent of participants in radiation oncology trials — or roughly 50 patients a year — have enrolled in their own communities rather than at the university’s main campus in downtown Baltimore.
“We’ve integrated telemedicine technology with our commitment to clinical trial access,” says Suntha. Telemedicine links provide a means for university-based investigators to communicate with patients while they’re in a study. They also allow CRAs to seamlessly transmit data mined at community-based sites.
Other academic institutions — Johns Hopkins and the universities of Arizona, Texas, North Carolina, and Michigan among them — likewise use telemedicine as a means to get clinical data from remote sites, including hospitals abroad.
The same technology can aid in the recruitment and management of subjects in clinical trials. Pharmaceutical companies would have much to gain by encouraging the use of telemedicine at community-based investigative sites and even in subjects’ own homes, according to Jay Sanders, founder and CEO of The Global Telemedicine Group (McLean, Va.).
For starters, trial participation would be more convenient and less stressful for people miles from major research institutions if they could accomplish study visits at home or in a familiar, nearby hospital or physician’s office, says Sanders. Data collection via telemedicine could also significantly cut monitoring costs of contract research organizations (CROs) and ensure the quality and integrity of the information. “Wireless sensors now exist that allow real-time recording of [all] critical physiological parameters on a continuous basis.” From anywhere equipped with a computer, “clinical data can be immediately inputted by email to a central data repository.”
This is neither a complicated nor expensive proposition, says Sanders. “There is a telemedicine system today [manufactured by BL Healthcare, Boston] that consists of a small set-top box with a single input and output outlet that immediately converts a channel on a normal television set into a totally interactive, 30-frames-per-second channel.”
Long Distance Monitoring
Tele-homecare today is taking place in roughly 30,000 households, most notably for patients of the Veterans Administration. “The more we looked at our ability to provide access where people live and work, the more we found out that the ‘exam room’ needs to be where the patient is, not where the doctor is,” says Sanders. Blood pressure values are generally better at home than at the doctor’s office. It’s also “more appropriate to assess pulmonary functioning at the location where patients breathe air most of the day.”
In terms of the transmission of imaging studies, ECGs, and results of in-home patient monitoring devices, there has been “significant use of telemedicine” in conducting clinical trials, according to Mark Goldberg, president of the perceptive informatics and clinical research services divisions of Parexel, and former president of the American Telemedicine Association. Use of in-home telemedicine technologies, in particular, have the added benefit of making trials more appealing for people to participate in because they are more convenient.
The technology is useful for trials only to the extent that the tools and devices are validated to collect data in a manner consistent with the applicable computer system regulations.
Telemedicine is, to a lesser extent, potentially valuable in the direct recruitment of patients into trials, or at least those seeking patients with rare diseases or conducted in remote locations like sub-Saharan Africa, says Goldberg. But people with unusual conditions may well travel to specialty centers for care, and trials conducted in far-flung regions of the world increasingly receive on-the-ground CRO support as clinical trials have become a truly global activity. On the other hand, telemedicine — particularly in the form of electronic data capture — could help reduce the amount of required on-site monitoring.
Another area in which telemedicine might be useful is in qualifying people for trials, says Goldberg. If the inclusion criteria for an arthritis trial include a minimum of disease, as evidenced by x-rays of the hands, telemedicine could be used to transmit those images from various, patient-convenient locations to a qualified image reader.
Study sponsors, rather than study sites, are likely to drive telemedicine usage and do so across studies, says Goldberg. Investigators who want to adopt a telemedicine tool — i.e., a scale to monitor weight for a congestive heart failure study — may well have to obtain both sponsor and institutional review board approval before using it in a trial.
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