Posted: Jun 21, 2018
Dr. Matthew Galsky is the Director of Genitourinary Medical Oncology at the Tisch Cancer Institute.
He is keenly interested in developing novel treatments for genitourinary cancers.
Prostatepedia spoke with him about his work exploring the feasibility and safety of using telemedicine to conduct clinical trials.
Dr. Matthew Galsky: Only a small portion of patients throughout the world, and in particular, the United States, enroll in clinical trials. Yet, this is really the only way that we advance the field in terms of understanding the risks, benefits, and comparative effects of new treatments. We noted that the conduct of clinical trials in the United States had several inefficiencies that could be addressed with technological solutions.
One of our initial studies looked at a large group of clinical trials that had been done in the United States and that had been captured in a large, public database. We looked at thousands of clinical trials done in the United States over a period of about a decade. About 25% of those clinical trials closed early due to poor accrual: not enough patients enrolled in the studies. The studies ultimately closed and didn’t answer the questions they set out to answer, which is a huge waste of financial and patient resources. The patients who enroll are altruistic and want to advance the field. But their participation did not accomplish what they had signed up for. This is a big problem.
Our next study was related. We looked at the zip codes of all of the sites that had open trials, we matched those to different cancers in the United States, and then we asked a very simple question. What was the average distance that a patient would need to travel to reach the nearest clinical trial? We focused on trials for some major cancers: prostate, lung, colon, and breast cancer. We found that 40-50% of the population resides greater than one hour driving time, one way to the nearest clinical trial site.
Wow! That’s far.
Dr. Galsky: It’s far and prohibitive for a large number of patients. It’s not surprising, but it’s disappointing.
We have one problem, that we don’t have enough patients enrolling, and then we have this related problem, that the studies are not geographically accessible to patients. This really hit home.
A study published in the Institute of Medicine in 2010 reported that clinical trial sites are typically opened where the nvestigators are located rather than where the patients are located.
That makes sense.
Dr. Galsky: Absolutely. But it creates barriers to enrollment.
We thought there might be a technology solution to this, and so we set out to test the feasibility of a prospective clinical trial with an intervention (studying a drug in prostate cancer), enrolling patients who lived at a distance by replacing the on-site study visits with telemedicine study visits.
It was a small study to establish proof-of-concept for this approach. The intervention was a drug called metformin, which is FDA approved for the treatment of diabetes. In various epidemiologic studies, it has been associated with potential anticancer activities and specifically anti-prostate cancer activities. For this pilot study, we had patients come to our site to enroll in the study because we figured that would require the least number of visits and at least one face-to-face interaction.
After that visit, the rest of the study was conducted by telemedicine, so patients took their pills at home. This medicine is oral. It’s a pill. We connected with them via telemedicine visits once a month to review their side effects and the numbers of pills that they had taken or missed. The patients had laboratory testing done locally with the results sent into us.
We were ultimately able to show that this is feasible in this specific context. Obviously, the deck was stacked in our favor to ensure we could do this safely, but it was possible.
Break down what you mean by telemedicine. Was this email contact?
Dr. Galsky: This involved video visits with patients. We had to use a platform that was HIPAA compliant and optimized for security, so we partnered with a company that had developed a technology they were using for purposes outside clinical trials, such as trying to prevent hospital readmissions by having nurses monitor patients remotely.
We gave patients a mobile device at that initial visit, a Samsung phone running the software for this platform. On our end, we connected with the software loaded on our desktop computers. With these tools, we were able to conduct video visits once a month.
Did you do any training for the participants?
Dr. Galsky: We did about ten minutes of training at that initial visit, and then we had prepared a pamphlet with troubleshooting questions and answers.
What can you conclude from your results?
Dr. Galsky: The primary endpoint of this study was to show that telemedicine was feasible. We defined feasibility as greater than two-thirds of the enrolled patients completing all of the eligible telemedicine visits. Each patient on the study had six planned telemedicine visits, but if they went off of the study because their cancer progressed, they had less than those six visits. Six visits per patient times 15 patients enrolled, means 90 total visits. We conducted 84 televisits with patients during the course of the study, so we met that primary endpoint of feasibility.
If patients had to go off the trial because their cancer progressed, that’s not really a failure as far as the telemedicine element, is it?
Dr. Galsky: Exactly. The primary endpoint was feasibility.
The secondary endpoint was safety and effects of the drug. We saw that seven of the patients had a minor decline in PSA while on the study.
So, metformin may have some activity warranting further evaluation of the treatment.
We did questionnaires at the end of the study regarding the patient’s rating of their experience with the telemedicine approach. We asked whether they would participate in a similar type of study in the future, and the majority agreed or strongly agreed that they would.
You made it easy for them to participate.
Dr. Galsky: That’s the key; absolutely.
What does this mean going forward? Should this kind of approach be integrated into more trials?
Dr. Galsky: There is certainly the ability to integrate telemedicine into existing studies using lower toxicity oral interventions to replace some of the study visits. That’s low-hanging fruit.
In terms of expanding to more complicated areas, there is potentially a pathway for investigational sites to partner with local groups to offer trials that are monitored and conducted on a remote basis with local physicians at the bedside. This is similar to what’s happened in the intensive care unit field.
There are a huge number of intensive care units within the rural United States that are staffed and monitored by intensivists that are sitting miles away in front of computer screens and interacting with the nurses and the physicians at that hospital just to manage the patients.
If it can be done for some of our sickest patients, then certainly there is a path forward to do this in other contexts. It’s just a matter of making sure that the regulatory environment is ready for this and that there is a buy-in from all of the stakeholders involved. We have proof that we can think differently about our entire clinical trials enterprise if we want to.
Dr. Galsky: We’re really focused on clinical trials. That’s our main interest. But we’re already seeing telemedicine in standard of care applications.
My colleagues here and at other institutions are already doing second opinions appointments via telemedicine. They’re doing postoperative visits via telemedicine. For prostate cancer and for other genital urinary malignancies like bladder cancer, where there’s been a centralization of surgeries and patients travel a distance for their surgery, then return to the care of their local teams, the ability to do postoperative checks at a distance offers the potential for significant value added. There is a range of applications for this type of technology.
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