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Monday, February 24, 2014

ONLINE FIRST: Using Telemedicine to Improve Clinical Trial Accrual




One reason many patients don't volunteer for clinical cancer trials is simple: They can't or don't want to commute to the cancer center for the extra visits a trial would require.


If traveling more than 30 miles for a clinic visit is considered a burden, then a new study shows that enrolling in a clinical trial would be a burden for more than 30 percent of men with advanced prostate cancer in the U.S.


The data are from a study presented at the Genitourinary Cancers Symposium, which showed that clinical trial sites are “poorly accessible geographically to a large subset of U.S. prostate cancer patients, a finding that likely contributes to dismal accrual,” the researchers reported (Abstract 59).


The same researchers, from Mount Sinai School of Medicine in New York City, reported in a separate study that 10 percent of clinical cancer trials are not completed because of failure to accrue a sufficient number of patients (Abstract 288; OT Online-First article).


“Innovative solutions are required to address geographic barriers to access,” the researchers, led by Matthew Galsky, MD, Director of Genitourinary Medical Oncology and Associate Medical Director of the Cancer Clinical Trials Office at Icahn School of Medicine at Mount Sinai, concluded, and indeed they are trying an innovative solution of integrating new information technology approaches to increase accrual and break down geographic barriers to participation.


Disruptive Innovation Fills New Needs

Telemedicine is not new to medical care, of course, but its use in clinical trials to overcome the geographic barrier would be a “disruptive innovation – i.e., technology that may not immediately displace the current way of doing things but opens new processes that eventually will replace the old ones, he said.


“Telemedicine won't be applicable to every clinical trial from day one, but in 10 years could there be a new way of thinking about doing clinical trials? We think maybe so.”


Galsky acknowledged that it will be easy for some to say chemotherapy can't be given remotely, or that Phase I first-in-human studies can't be done remotely. “We certainly appreciate those potential criticisms, but this is really creating a new model for an activity that was carried out in different ways historically.”


As described in a separate OT article, Galsky has partnered with Transparency Life Sciences ( to test the feasibility of a telemedicine approach to clinical trials, with a pilot prospective study of metformin in advanced prostate cancer, expected to be open for enrollment this spring.


Patients who volunteer for the trial will come to Mount Sinai for a single visit, and the rest of study will be done via telemedicine visits once a month for the six months of the study. Patients will be given the supply of medicine at that first visit, but the drug could also be mailed if necessary.


Monitoring of safety, side effects, and quality of life will be done through a secure video monitoring platform on tablets given to patients. In a setup similar to that of Skype, the doctor and patient will see and talk to each other. Galsky said the system is HIPAA and HITECH (Health Information Technology for Economic and Clinical Health) compliant.


He is also exploring a system of monitoring compliance by telemedicine. He described a medication adherence monitor that will register a Bluetooth signal to the data base each time patients open the drawer to take out their medicine. “It doesn't tell us that they have actually taken the medicine, but it will tell us that they have accessed the medicine,” he said.


The next level of the concept will be using telemedicine to integrate local physicians with study physicians, and he is also in discussions with a company that has a process that allows blood to be drawn in very small quantities so that the sample could be mailed to a central lab.


30 Miles a Travel Burden

For the trial reported at the GU Symposium, Galsky and colleagues used to identify all active U.S. clinical trials exploring first-line therapies for metastatic prostate cancer on Sept. 16, 2012. The researchers evaluated the geographic distribution of trial sites and estimated the minimum driving distance from each ZIP code in the contiguous U.S.


A distance of more than 30 miles was defined as high travel burden. There were 958 sites associated with 42 metastatic prostate cancer clinical trials. Among 3,185 counties, 2,669 (about 84%) had no clinical trials available for first-line treatment of metastatic prostate cancer, although counties with larger populations of patients with advanced prostate cancer did have significantly higher numbers of clinical trial sites.


The team determined the relationship between the number of sites and the number of patients with advanced prostate cancer per county, and found a high degree of inaccessibility, since approximately 31 percent of the U.S. population resided more than 30 miles from a prostate cancer trial site.


We have prior research showing that cancer clinical trials are geographically inaccessible to a large proportion of patients in the U.S.,” Galsky said. “There are centers that are very skilled in doing clinical trials, but that is not necessarily where the patients are.”


The project he and colleagues are launching will integrate telemedicine into the clinical trial process as patients visit a study center for their initial exams, and the rest of the visits will take place via secure video telemonitoring –thus easing the travel burden and the expense of participation as well as, it is hoped, the costs of the clinical trial process and speeding drug development, he said.


PCF Targets Stake Holders

The Prostate Cancer Foundation (PCF) played a role in getting the telemedicine project off the ground because they were interested in targeting a large number of the stake holders in prostate cancer research and treatment – i.e., patients, advocates, and researchers.


Jonathan W. Simons, MD, PCF President and CEO, said he is excited by the prospect: “If Amazon and Netflix customers can access all kinds of transactions via the Internet, why can't cancer patients access cancer trials?”


Telemedicine will not be a replacement for sophisticated, tertiary-level designated cancer center clinical research. “But for outpatient, low-complexity but high-scientific merit clinical trials couldn't the Internet be used ethically to improve accrual?” he asked rhetorically. After all, he said, he has an app on his iPhone by which he can look at a patient's MRI with HIPAA confidentiality.


The problem of low trial accrual has been thought due to poor health literacy, Simons said – i.e., that patients are afraid they'll be on placebo, or are not well educated about the goals or requirements of a trial.


“But maybe a lot of the problem with accrual is that patients can't afford the time or the expense of getting to the trial site,” he said. “Up to now, the Prostate Cancer Foundation has been doing what everyone else has done, using all the 20th Century methods, educating patients and nurses, CME, but we've never done anything about driving time, and that may be the biggest barrier.”


“If using the Internet could increase the current standard accrual rate for adult cancer patients of only three to four percent to, say, 12 percent, that still means you get the answer three to four times faster, speeding the time to answers of efficacy and side effects from the trial.”


The next step, Simons said, is for Galsky to show that accrual is increased with telemedicine and that the quality of research is the same or better.


Meanwhile, Simons said, “if it's a great idea, someone will have to oppose it -- that's human nature.”