Can you picture a clinical trial site coordinator getting a text message about a patient at risk of dropping out of a study? What if that text comes automatically from the supporting technology inside the patient’s home?
This isn’t a far-fetched scenario. Digital technologies are at work today helping make clinical trials and patient care more efficient, effective, and patient-centered. Thanks to technology, we can collect better data and ultimately get better health outcomes through advances such as decentralized trials and real-world evidence.
But using technology in the patient setting does not guarantee success. If you’re responsible for selecting and deploying digital tools for clinical trials, you have some big decisions that can make the difference between a successful outcome and a process that leaves you asking what went wrong.
I had the chance recently to discuss a novel, collaborative approach to these critical technology choices with Kelly Roland, associate director at Otsuka. Kelly and I presented at the SCOPE 2021 virtual conference in March. The audio and slides from our talk give an inside look at the steps Otsuka took to making sure their technology choices could support gathering real-world data.
To expand on the talk, Otsuka and Spencer took away a couple of important learnings from working closely together in the early stages. These are lessons that I think other pharma companies and researchers may consider in deciding on digital tools and technologies.
First, get your hands on the technology and use it. A lot of new tools and applications have come on the scene in the last few years in the clinical trials market. It’s one thing to read third-party reports on a piece of technology and talk to the technology provider. But it’s another step altogether to personally use the device or platform and then apply those learnings to the design for patient protocols.
At the outset of our work with Otsuka, Kelly and her team established an internal focus group that used the spencer smart hub. We established a protocol and shipped spencer units directly to the homes of focus group members. Like a patient, they got to set up the device, experience using a spencer, and evaluate it.
In instances where patients are using biometric devices, apps, or in-home platforms, it’s a relatively easy step for the trial sponsor or research team to evaluate and use the technology first-hand and learn from that personal experience.
And that leads to the second lesson we learned in working with Otsuka: Get as close to the patient experience as possible. As trials continue to shift to meet patients where they are, technology choices become more important. There are varying levels of tech literacy in any group of patients, so it’s important for trial sponsors to make sure the technology is not a barrier to participants.
Hands-on experience with the technology will help the research team see what the patient experiences. This could include how easy or difficult it is to set up, whether the materials are easy to read, how intuitive it is to use every day, and what to do if there’s a problem. This is what the Otsuka team did, and this step of putting themselves in the patient role helped deliver valuable insights for their approach going forward.
I hope this type of collaboration between pharma and technology providers will become more common. There’s no substitute for getting the first-hand experience with the technology and using it as a patient would. With all that’s at stake in any clinical trial, especially decentralized trials, it just makes sense to know as much as possible about the technology upfront so you can make informed decisions throughout the process.
Tom Rhoads, MBA, has been leading the development and launch of healthcare technology for 25 years. As founder and CEO of Spencer Health Solutions, he led the development of the direct-to-patient spencer® medication dispensing, telehealth, and in-home monitoring platform. Prior to his current role, Rhoads was CEO of Parata Systems pharmacy automation company and previously held leadership roles at Baxter Healthcare and Cardinal Health Corporation. He is a member of the Advisory Panel Member for the Centers for Medicare and Medicaid Innovation (CMMI) Services, Payment and Program Evaluation grant in North Carolina.