In today’s real-time, data-driven world, clinical trials are also reaping the benefits of this data influx. The increasing usage of integrated devices, like personal medical devices, and the integration of electronic Clinical Outcome Assessments (eCOA) with electronic Patient Reported Outcomes (ePRO) platforms have brought a wave of innovation and improvements.
Medical Devices
To begin, let’s focus on simple and easy-to-use FDA-cleared medical devices that offer patient convenience with clinical accuracy. They are revolutionizing how clinical trials are conducted and how patients are monitored. The importance of medical devices is their data accuracy. This provides confidence in the reliability of collected clinical trial data, regardless of where the patient is located.
A necessity in today’s decentralized trials and real-world evidence is the desire to continuously monitor and record real-time health data of a patient’s expanded vital signs. This includes medical-grade heart rate, brachial and central blood pressure, arterial stiffness, and others that directly link to a category referred to as ‘digital vascular biomarkers’. These biomarkers provide a holistic perspective of a patient’s vascular health. They share key clinical insights into associations related to disease, sleep, prescribed medications, physical activity, and therapeutic programs. The result is a vast collection of high-quality, patient-centric, and real-time data to personalize the interaction with patients during a clinical trial. They also include alerts to detect adverse events sooner to improve patient safety during the clinical trial.
The benefit of patient monitoring is the positive impact on patient enrollment and engagement. By expanding the sphere of patients who have the opportunity to participate in trials from the comfort of their homes, these devices encourage higher enrollment and retention rates. It’s an undeniable fact that when patients feel comfortable and involved, they are more likely to remain engaged and continue to participate in the trial.
eCOA and ePRO Platforms
Now, let’s turn our attention to eCOA and ePRO platforms. These electronic tools facilitate the collection of patient-reported data. As tools, they provide patients with convenient and intuitive access to provide updates on their health and well-being. They also supplement the physiological data collected from medical devices. Essentially, the patient voice is captured through these quick-to-access technology platforms.
The complementary use of integrated medical devices with eCOA/ePRO platforms provides a patient-first clinical trial perspective. This enables patients to monitor their expanded vital signs in real-time. This instant feedback allows for a more proactive approach to actioning interventions and personalizing how a patient’s health is managed.
Patient Experience
How does this impact the patient experience? Simply put, it’s a game-changer. Patients gain a better understanding of their health journey during a trial, which can be a powerful motivator for continuous engagement. Patients may become active participants in their healthcare journey rather than passive observers, motivated to make a change and remain enrolled.
In addition to enhancing the patient experience, the increase in data availability positively impacts clinical trial patient outcomes. Essential and high-quality vital signs data collected in real-time provides for actionable interventions to allow a clinical research coordinator to be alerted to a patient’s digital biomarker prior to an adverse event. This significantly advances patient safety in clinical trials. It increases the likelihood of detecting small and significant clinical and vital signs changes for each patient.
The rise in data obtained from integrated devices, coupled with the powerful partnership of eCOA and ePRO platforms, is a benefit to researchers. These advancements are improving patient engagement, ensuring higher trial retention rates, and, most importantly, improving patient outcomes. The future of clinical trials is here, and it’s data-driven.
Conclusion
Datacubed Health recognizes the value of wearables in clinical trials. Recently we partnered with ATCOR Medical to improve patient safety and engagement with the real-time monitoring of digital vascular biomarkers as enhanced vital signs data. Check out our press release to learn more. When you’re ready, schedule your personalized demo with our team to discover how eClinical and integrated devices can level up your studies.