The Digital Health Continuum – Connecting Clinical Trials to Care Delivery

By Efren Rael, M.D. - Senior Medical Director, Clinical Affairs – Biofourmis

When a patient visits a doctor’s office, the physician may assess vital signs, conduct a physical examination, perform blood work, or run other diagnostic tests to evaluate the patient's health at that particular moment. These interactions provide a snapshot of the patient’s health at a given time. While this form of assessment has long been considered the gold standard of care, it falls short of providing a complete picture of the patient’s day-to-day health. This limitation makes it challenging to identify underlying factors that affect long-term health outcomes.

We are currently experiencing a digital healthcare revolution that is shifting the paradigm from asynchronous snapshots to a continuous film reel. Connected digital platforms and the widespread use of user-friendly wearable biometric sensors and devices offer continuous monitoring capabilities that integrate with electronic medical records. These tools supplement the episodic record and allow for the assessment of the real-world impacts of lifestyle choices and changes in care plans.

These digital tools also have significant value in drug development, as scalable clinical research platforms now enable the collection of continuous real-world data and support the shift of trials from clinic sites to patient homes. By remotely collecting data using a combination of novel digital endpoints integrated with in-home care delivery and study visits, sponsors can alleviate the burden on patients, thereby improving patient retention. These technologies also enable sponsors to accelerate patient recruitment in a wider geographic area, identifying diverse patient populations that meet study-specific inclusion and exclusion criteria, and ultimately enabling faster trial initiation.

Overcoming technical challenges

There have been some technical hurdles to overcome in the path to healthcare digitization. For instance, some early devices were linked to patients' phones, which caused compatibility and connectivity issues. These concerns can now be addressed by connecting devices directly to the cloud via adaptable cellular networks.

Digital literacy and comfort with technology previously restricted some patients and physicians. However, as more people have incorporated connected wearables such as smartwatches and fitness trackers into their everyday lives, the adoption of digital devices in healthcare settings has become easier.

Often times, organizational barriers hinder the adoption of digital tools. For instance, physicians at a medical center may be eager to adopt a new digital solution, but their IT department may be hesitant to integrate novel technologies into existing systems. Healthcare technology companies can help overcome these barriers by providing flexible connectivity options that give physicians direct access to digital platforms without requiring direct IT integration.

Long-term monitoring and prevention of adverse events

Many clinical trials today are incorporating continuous real-world evidence to assess long-term outcomes. Digitally connected devices enable ongoing patient monitoring and remote data collection, which is less expensive than frequent in-person visits and more convenient for study participants.

Digital devices that provide continuous monitoring can also minimize the risk of reportable serious adverse events and reduce hospitalizations. For example, consider a patient with chronic heart failure who takes multiple medications that must be balanced to work together. Continuous remote monitoring can facilitate home-based management of the treatment regimen and medication titration by collecting symptomatology and physiological parameters. At the same time, the patient can be monitored for any changes in physiology that could indicate clinical deterioration, allowing for timely intervention before hospitalization becomes necessary.

More information leads to better care

As a physician, I was taught that a physical exam is essential, and it has been the medical dogma for centuries. Person-to-person direct care will undoubtedly continue to play a vital role in healthcare, but we also need new approaches to address the growing demand for care.

Physician shortages are becoming increasingly prevalent as many providers retire early, and new physicians are expected to manage ever-increasing patient loads. Therefore, we need a more adaptable healthcare delivery model to meet the pressures that the system will experience in the next few decades. Advanced digital technologies can help in providing care, performing triage, and developing new therapies to address previously unmet needs. These technologies offer immense potential in revolutionizing healthcare delivery and improving patient outcomes.

Digital healthcare tools have broad applications across various disease pathways, but their value is particularly evident in managing chronic conditions such as COPD, heart failure, and oncology care. These conditions often require long-term monitoring and careful tracking of health metrics. Digital tools excel in providing real-time data and insights that augment clinical decision-making, enabling healthcare providers to make more informed treatment choices.

By leveraging connected digital health tools, providers can access a wealth of information about their patients' health, both in clinical trials and chronic care situations. This wealth of data empowers providers to make more accurate diagnoses, tailor treatment plans to individual needs, and ensure patients receive the right therapies at the right time. Additionally, digital tools facilitate ongoing monitoring, allowing providers to track patients' progress remotely and intervene proactively when necessary.

Most importantly, the personalized nature of connected digital health tools fosters patient engagement and adherence to treatments. By providing patients with continuous feedback, reminders, and personalized insights, these tools empower individuals to take an active role in their own healthcare management. This personalized approach can help enhance treatment efficacy, leading to improved patient outcomes and ultimately enhance the quality of care delivered.

Join the digital health revolution today, and talk with Biofourmis about how to connect your drug development innovation with tech-enabled care delivery.

The editorial staff had no role in this post's creation.