Where Technology is Reducing or Increasing Burden on the Clinical Trial Site Level
Clinical research coordinator Jillian Agnew, RN, CCRC, St Johns Center for Clinical Research, highlights how technology has enabled her patients to connect virtually to clinical trials, but how some devices are increasing burden on her staff when they are not 100% fit-for-purpose.
Where have mobile and digital technologies been the most useful to you in treating patients?
We use mobile study apps for patients who take a study drug every day or once a month, while participating in multi-year trials. They record their study doses at home, which reduces the burden of site visits to check their compliance. The apps also send us notifications when participants miss doses, so we can follow up before it becomes a protocol deviation.
Effective technology allows patients to stay away from the site longer, and makes what could potentially be a really burdensome commitment to a long trial more manageable. They can travel without having to worry about rescheduling visits or being out of the protocol-specified visit window.
How did that technology reduce the burden on you?
As a site, it frees up our schedules because I'm not seeing that many patients every single month. It allows me to focus on other trials or recruiting more for these trials.
When patients come in with questions about the technology, it is an opportunity to build rapport and trust. That helps with retention.
"Effective technology allows patients to stay away from the site longer, and makes what could potentially be a really burdensome commitment to a long trial more manageable."
What have been the challenges you’ve faced, in implementing these devices and tech?
Most supplied devices are Android. The patient population I work with are often 65+ and don’t have a smartphone by choice. When they do have a smartphone, it’s an iPhone.
If you’re only familiar with an iPhone, it’s not intuitive to use an Android. It’s difficult for our taff to use, and to teach to patients, particularly when that patient doesn’t even want to use it in the first place. That leads to some protocol deviations, between when they take the dose and when they record it.
What is the solution you’d like to see?
I would love to see patients be given the option to use either an Android or an iPhone if they are required to use a mobile device for a trial. Patients do have the ability to use their own phone and download the app, but they often choose to use the device provided by the trial for convenience.
What’s a mobile/technology hurdle you’re currently working through?
Shipping IP to patients’ homes. There has been a rise of shipping IP to homes, and using local home health agencies and in-home visits. We have a lot of patients in Florida who will go north in the summertime and be away from the site for multiple months. For those patients, I have to ship the drug to them and coordinate the home health visit.
What makes it such a challenge?
It is cumbersome. For example, we are shipping IP to a patient in Nevada. It took my CRA going down a few different avenues to figure out how to do it – how to get the vendor, where to pick up the drug, what forms needed to be filled out.
What made it more difficult is that, at a certain point, she had to be cut out of the loop because the process included direct patient information, and the CRA is blinded. That left me dealing with the vendor on my own. There were challenges with temperature, with delivering to the right location, etc. If we have consistently faced challenges, I imagine other sites have as well. I don’t have a solution yet, as we’re still working through it.
"I want to see more research going into the choosing of the device to ensure that they are fit-for-purpose for the specific population. Any device you’re giving to patients should be ready to go live."
Is there anything you’ve learned about administering IP at home that you want to make aware of for sponsors?
When a patient comes into the site for lab work, drug administration and monitoring, it is an hour-long visit for which they get a stipend. When a nurse goes to a patient’s home, patients are expected to set aside a four hour window of time for this to all take place, but the stipend remains.
They don’t have to travel to the site, but while we aren’t paying them for travel, we’re still paying them for their time. If this is going to take a huge block of their day, I think that should be reflected in their compensation.
For the industry readers, where would you like to see more problem-solving behind?
For any sponsor reading this, be very mindful of the technology you're asking us to use. Whether you realize it or not, you’re asking us to teach it to an older population and serve as their tech support. The less we need to trouble-shoot, the less burden we’re facing. I want to see more research going into the choosing of the device to ensure that they are fit-for-purpose for the specific population. Any device you’re giving to patients should be ready to go live.
Sometimes it can feel like that technology is still in “focus group mode.” For example, my patients don’t have great eyesight, and they can’t often read the text on the device. I’ve had a patient say to me, “It feels like this trial was set up for someone 20 years younger than I am.” That increases site burden, because when patients do have trouble, they want the site to figure it out.
