Digital Health

Digital health is here to stay. Consumers are seeking insights into their own health, while providers want to follow patients’ vitals between visits and researchers rely on remote data capture for decentralized clinical trials (DCTs). These trends are driving the digital health market, which is poised to more than double — reaching upwards of $220.9 billion — by 2026.

The growth of digital health — wearable sensors, devices, mobile health, telehealth and health information technology — and its increased reliability has meant consumers and researchers have access to a wider range of options to collect patient data. Devices and apps count steps, track heart rate, assess sleep quantity and quality, and continuously track blood glucose and blood pressure levels.

Remote patient monitoring (RPM) is critical in gathering objective, high-quality data that enables researchers to assess safety and efficacy of a therapeutic in real time. And while there are risks inherent in this (and any) digital process, those risks can be mitigated to realize a tremendous potential upside.

Benefits of digital health in clinical practice and DCTs

The value of digital health and remote data grew clearer during the COVID-19 pandemic. Over the past 20 months, patients and providers have grown more comfortable with telehealth, and the DCT model became more necessary. But the benefits of digital health extend far beyond this moment in time.

Improved outcomes/population health. Real-time remote data capture allows providers in a clinical setting as well as DCT staff to closely monitor patients’ vitals. At any sign of a problem, clinicians can call the patient to request additional information and data, change course on treatment, or remove a participant from a trial. They could even stop a trial completely before undue harm is done.

Better patient experience. Using digital health devices that remotely monitor important metrics, patients and participants are able to provide key health data without having to regularly disrupt their lives for clinic visits. Especially for patients who need to travel great distances for care, the minimization of this burden cannot be overstated. They save money on fuel and mass transit, don’t have to take time off work, and don’t have to pay for childcare.

Empowered patients. Remote patient monitoring may be designed to give clinicians objective data in real time, but patients also have access to the data via their activity trackers, sleep monitors, and other devices to empower their own personal health decisions.

Improved provider experience. Cutting down on unnecessary clinic visits helps reduce provider load, allowing them to spend time with patients more productively. They also have visibility into how their patients health is tracking between visits which can bring greater insights and patient monitoring to the physician

Enablement of DCTs. Decentralized clinical trials and the platforms they run on are only as good as the robustness of the digital data collected in the trial. As the digital health industry continues to expand, the types of the data — and the quality of that data — only stand to grow.

Digital health risks

It’s important to understand the various risks presented by the digital health landscape. First, because medical devices are not regulated by the U.S. Food & Drug Administration, it’s important to thoroughly vet any product used to remotely monitor patients. Also, security of patient data is always at the forefront of digital health conversations. When discussing remote patient monitoring, it’s incumbent upon providers and clinical trial sponsors to partner with platforms that have the strictest IT security protocols.

Other potential risks include device malfunction, sustainability and supply chain, cost and privacy or ethical issues, like the possibility for RPM to exacerbate health inequities, as digital device use tends to favor a population that is already inclined toward better health.

Of particular concern in DCTs is the standardization of patient data capture. Without standardized methods and formats, clinical trial results can be in a position to be misinterpreted.

Improving remote patient data capture

With a few key steps, it’s possible to reduce the risks around remote patient monitoring and improve the process for the population you serve.

Enhance patient/participant education. Ensuring that patients have all the information they need to make an informed decision to participate in remote patient monitoring — and are educated on their responsibilities in the process — is essential. A well designed and implemented eConsent solution can support an enhanced education for patients when it is designed around the patient experience.

Develop clear protocols. Clear, well-thought-out provider or trial protocols are essential to ensuring standardized patient data collection, a consistent patient/participant experience, and the best possible outcomes. Data collection workflows should be designed around the patient and remove burden where possible, collecting measures which matter bring compliance and patient retention

Ensure timely evaluation of data. When clinicians review patient data in a timely manner, they are able to make important real-time decisions that affect patient/participant health and safety. Aggregating data and unifying visualizations can bring patients insights which support clinicians to make individual and timely patient relevant decisions.

Partner with The RC Clinic to mitigate risks

Working with an established software solutions provider like The RC Clinic can help improve the patient and site experience whilst mitigating IT- and data-related risks. TRC's remote patient monitoring solution:

• Increases patient monitoring while reducing patient burden, allowing patients to collect trial data without interrupting their lives
• Empowers real-world patient data collection through TRC's fully integrated connected sensors and measurement ecosystem
• Decreases deployment time by using readily available sensors, while giving participants more choice
• Provides study teams with real-time patient oversight as well as context and quality of life data
• The ability to connect to an end-to-end platform that centralizes eConsent, Telehealth, connected sensors, eCOA, and ePRO data in one place for investigators, supporting study teams in their decision making