The Rise of Remote Patient Monitoring and Decentralized Clinical Trials
In the past century, the concept of decentralized care has been a topic of interest. However, it is only in recent years that the necessary elements have evolved to make decentralized clinical trials (DCT) and remote patient monitoring (RPM) a reality. The COVID-19 pandemic has accelerated the adoption of these practices, leading us to question what comes next and how we can move forward in a pragmatic manner.
The Evolution of Decentralized Clinical Trials
While DCT is not a new concept, its definition and execution have been the subject of confusion. Craig Lipset, a clinical research pioneer, highlights early trials with a decentralized design that date back to the early 2000s. However, it is only recently that a more standardized definition has emerged.
According to the Clinical Trials Transformation Initiative (CTTI) guidance, DCT refers to trials in which some or all study assessments or visits are conducted at locations other than the investigator site. This definition highlights the role of technology in enabling participation and reducing the burden on patients, while also promoting broader access and diversity in clinical trial populations.
Pharmaceutical companies and contract research organizations (CROs) now have the necessary tools and technologies, such as remote patient monitoring devices and electronically gathered data, to conduct decentralized drug development trials. The COVID-19 pandemic has further pushed the boundaries of how these trials are established, conducted, and validated. The question now is how we can leverage the lessons learned from both pre- and post-COVID times to benefit all stakeholders.
The Patient Perspective on Decentralized Trials
From the patient’s perspective, decentralized trials offer several advantages. Many aspects of clinical trials can now be performed remotely, increasing convenience, accessibility, and diversity. Remote patient monitoring devices, such as wearables, enable patients to participate in trials without the need for extensive travel. These devices must be designed with patient comfort, reusability, and self-service in mind to ensure patient adherence.
The COVID-19 pandemic has forced populations to rapidly adapt to digital healthcare, including telemedicine. This presents an opportunity to further capitalize on this adoption by driving participation in decentralized trials and expanding access to previously underserved populations. However, it is crucial to address any issues and develop solutions to ensure that the progress made during the pandemic is not transient and that patient-centric drug development continues to evolve.
The Pharma Viewpoint on Decentralized Trials
From the pharma viewpoint, decentralized trials offer new possibilities for drug development. Remote patient monitoring has been used for disease management for many years, and its adoption has been accelerated by the pandemic. Recent studies have examined the adoption trends of remote patient monitoring by provider specialty, geographical location, and diagnosis.
One study analyzed remote patient monitoring claims from January 2019 to March 2021, involving 20 million commercial and Medicare Advantage enrollees. The research found that during the pandemic, there was a significant increase in general remote patient monitoring claims, with 50% of those claims coming from primary care providers. Notably, there were no significant differences in remote patient monitoring use based on condition complexity, number of chronic conditions, and disease control.
Another study focused on remote patient monitoring claims from February 2020 to September 2021, specifically looking at traditional Medicare enrollees. The research revealed a 555% increase in general remote patient monitoring claims during the pandemic, with primary care providers accounting for the majority of claims. The most common diagnoses associated with remote patient monitoring were hypertension, diabetes, and sleep disorders.
While the benefits of remote patient monitoring, such as reducing hospital admissions, have been observed in some cases, it is essential to balance the costs with the potential benefits. Randomized clinical trials of remote patient monitoring have shown mixed results, emphasizing the need for further research and targeted use cases to fully understand its clinical value.
The Value and Challenges of Remote Patient Monitoring
Remote patient monitoring has shown early promise in improving outcomes for patients with select conditions, such as obstructive pulmonary disease, Parkinson’s disease, hypertension, and low back pain. However, further research is needed to fully understand the potential benefits and determine which patients would benefit the most from remote patient monitoring services.
One notable area where remote patient monitoring has proven effective is in the management of hypertension. Studies have shown that remote patient monitoring can lead to significant decreases in systolic blood pressure for patients over 55 years old. This indicates that remote patient monitoring could be an effective tool in hypertension treatment for a specific patient cohort.
Furthermore, remote patient monitoring has shown potential in reducing costs and hospitalizations for patients with chronic obstructive pulmonary disease and heart failure. While the results haven’t always been statistically significant compared to the control group, the cost savings per person indicate that a larger study could yield significant cost and utilization savings.
As remote patient monitoring continues to be adopted and innovated, questions arise regarding its novel value and use cases, as well as how to address reimbursement going forward. Research is urgently needed to determine the patients who would benefit the most from remote patient monitoring and which devices and specifications provide the highest clinical value.
The Future of Remote Patient Monitoring and Decentralized Trials
The rise of remote patient monitoring and decentralized trials presents new opportunities and challenges for the healthcare industry. As the public health emergency subsides, the federal government will need to adjust reimbursement policies to support the long-term sustainability of these practices. Healthcare providers must analyze the value of remote patient monitoring and decentralized trials for their patients and clinicians, considering their potential to lower costs and scale care with current workforce constraints.
Further research and targeted use cases are crucial to fully unlock the potential value of remote patient monitoring and decentralized trials. By understanding which patients would benefit the most and which technologies offer the highest clinical value, we can continue to improve patient outcomes and drive innovation in the field of healthcare.
In conclusion, the evolution of remote patient monitoring and decentralized trials has been greatly accelerated by the COVID-19 pandemic. Patients can now participate in trials remotely, reducing the burden of travel and increasing accessibility and diversity. Pharmaceutical companies and CROs have the tools and technologies to conduct decentralized trials, but further research is needed to fully understand their value and optimize their implementation. The future of healthcare lies in leveraging remote patient monitoring and decentralized trials to improve patient outcomes and drive innovation in the field.