In the world of digital endpoint design, taking a two-pronged approach is key, and Dr Joe Newman, a clinical researcher at the University of Cambridge, has some insights to share in a recent Garmin Health Research webinar.
He discussed his approach to working with Aparito and Garmin Health to conceptualise digital endpoints for clinical trials with a focus on both the patient and research perspectives.
Engaging with patients
What really sets this approach apart is the emphasis on engaging patients early in the process.
As Joe explained, the questions researchers ask are different from those patients ask. Researchers focus on technical aspects like validity, test-retest repeatability, and responsiveness to change. Patients, on the other hand, care more about usability, engagement / long-term use over time, and safety. By designing endpoints in parallel and cross-talking between both perspectives, Joe believes we can create digital tools that patients will actually use.
This is especially relevant to Joe’s area of interest: pulmonary arterial hypertension. This rare disease is characterised by increased resistance and pressure in the blood vessels in the lungs, leading to symptoms like breathlessness. While there are treatments available, the prognosis remains poor. Current endpoints are largely hospital-based, but Joe and his team have developed patient-reported outcome measures that can be administered remotely. They’ve also partnered with a company called Thriva to test whether blood tests from finger prick capillary samples can be used in the home setting to measure a cardiac biomarker called NT-proBNP in relation to pulmonary hypertension.
The approach started with the patients themselves. Through a collaboration with the Pulmonary Hypertension Association (PHA UK), a patient advocacy group in the UK, he conducted focus groups and an online survey.
The results were promising: 95% of patients in the UK have a smartphone, and 87% are confident in using apps. Even more encouraging, 93% of patients who don’t currently use a wearable device would be willing to do so to measure their activity most of the day if it was provided for free as part of a clinical trial.
The Digital 6MWT
But the real focus of Joe’s talk was on exercise capacity testing. The most familiar test in this field is the 6-Minute Walk Test, where patients walk up and down a corridor for 6 minutes while their physiological parameters are measured. This test is used in many different types of diseases, and Joe believes it can be adapted for remote use.
With digital tools such as the Aparito Atom5TM platform and Garmin® smartwatches, patients could perform this test at home and make clinical trials more accessible and convenient*.
This approach to digital endpoint design is refreshing in its patient-centeredness. By engaging patients early and often, Joe believes we can create digital tools that will make clinical trials more efficient and inclusive. Patient-reported outcome measures, blood tests from finger prick capillary samples, and exercise capacity testing can all be delivered from the comfort of patients’ homes. With this approach, patients can stay engaged, comfortable, and safe, making it easier to ensure the success of a clinical trial.
Solution accepted?
But the question remains: what does it take to accelerate the acceptance of these digital solutions?
According to Joe, it all comes down to acceptance. Patients need to be willing to use the technology that’s designed for them, and providers need to trust in its accuracy and clinical relevance. So what’s needed to make this happen?
For patients, Joe emphasises the importance of usability and simplicity. This means designing interfaces that are aesthetically pleasing, minimising button clicks, and gathering extensive feedback from patients to optimize the technology’s design. Patients also need to see the value in the data being collected, which is where providing digital diaries and progress tracking comes in handy. And perhaps most importantly, patients need reassurance that their data is being used and governed responsibly.
But what about providers? For them, Joe stresses the importance of trust in the data being collected and its clinical relevance. To achieve this, it’s important to work closely with patients and optimize the signal-to-noise ratio to filter out irrelevant data. Ultimately, the technology needs to make healthcare providers’ lives easier, not harder, by reducing workloads.
And when it comes to using wearables in clinical research, Joe believes that patients should not incur the costs themselves.
After all, we don’t want to create health inequality between those who can afford the technology and those who can’t, or those who have the digital literacy skills to use it and those who don’t.
Watch the webinar on-demand
Want to know more about Dr Joe Newman’s work with Aparito and Garmin? Watch the Garmin Health webinar on-demand here.
About Garmin Health
Garmin Health provides custom enterprise business solutions that leverage Garmin’s extensive wearable portfolio and high-quality sensor data for applications in the corporate wellness, population health, and patient monitoring markets. As part of a global company that designs, manufactures and ships products worldwide, Garmin Health supports its customers’ commerce and logistics needs, allowing enterprises to scale with a single, trusted partner.
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