Prior to the pandemic, there was a growing interest in shifting clinical trials to virtual or decentralized models to boost patient recruitment, improve retention, reduce costs and more. The pandemic only accelerated the movement. Clinical research teams pivoted quickly to operate remotely as needed, while adjusting their standard operating procedures to account for the evolving lockdowns. The continuing popularity of web-based technology solutions supported a rapid transition. It enabled these teams to continue working with minimal disruption.
Today, clinical trials are a mix of traditional, hybrid, and virtual or decentralized designs; most trials lie somewhere on a continuum between traditional site-based and entirely virtual, decentralized models. These new models offer many benefits. Technology plays a key role, and a flexible platform is critical for success. Automation has the potential to increases data quality while reducing the time and resources required to manage data, and it will continue to drive innovations in this area. The initial investments in new technologies to enable virtual or decentralized practices has the potential to result in significant efficiencies over time.
Digital recruiting and enrollment campaigns will attract more diverse populations and provide more comprehensive and accurate results that are relevant to broader populations. In a recent Mednet customer survey, fifty-five percent of respondents said they are planning hybrid, virtual or decentralized trials because of the increased ability to recruit study participants. Passive, continuous data collection provides unprecedented amounts of patient data without requiring additional staff. These digital enhancements could show significant cost avoidance over time. Furthermore, the ability to gather data from new and varied sources brings the potential to deliver highly valuable insights to better inform the clinical trials and approval process.
Decentralized trials also have the potential to decrease clinical trial costs. Automation that increases data quality while reducing the time and resources required to manage data, will continue to drive innovations in this area. Initial investments in new technologies have the potential to result in significant efficiencies over time.
Challenges to Innovation
The evolution of decentralized trials brings some new challenges to research teams that impact every aspect of the clinical trial. Data integration is probably one of the biggest challenges. New data sources and formats being collected in greater volumes and speeds than previously imagined must be managed. Research teams must analyze the constant stream of data coming from wearables. Putting it into context with other data requires new levels of interoperability. This challenge will probably continue to grow as trials become more complex and new devices and technology come to the marketplace.
Decentralized trials have a potential risk of compromising patient safety. There may be aspects of a patient’s health not visible in a telehealth visit that might be more visible and / or apparent in an in-person visit. Decentralized trials must address the ability to recognize a safety issue without compromising a study participant’s health or privacy.
The concept of decentralized trials suggests an improved patient experience. However, it also indicates the patient takes on a more active role in the study by directly tracking and reporting data and outcomes. Automation may address this concern, but it may not be appropriate in some scenarios. If the patient population is older, they may have difficulty adapting to using a mobile application or device. A younger population using the same application may have completely different results.
Communication practices are changing, and this shift creates challenges for trial teams. As different technologies are deployed, automated triggers and alerts to patients and the care team can vary from merely convenient to critical for success. As patients have questions about an application, device or the study, their concerns must be quickly triaged and addressed as part of the patient experience.
Considerations for Choosing a Technology Solution
As we’ve witnessed in the past year, the demands and requirements of clinical research can change quickly. While the industry has typically been relatively slow to evolve, the past year has taught us that rapid evolution and innovation is indeed possible. New technologies, analytics and data sources, coupled with consumer expectations and demand, will push innovation further. Research teams need to be prepared with technology solutions able to meet the demands of the industry.
Comprehensive, flexible platforms offer a unique balance of the flexibility and scalability the evolving clinical research industry requires. As the requirements for the suite of tools needed to support clinical trials continue to grow, flexible platforms with a combination of robust features while allowing for integrations are poised to meet the needs of most clinical research designs. A robust native feature set delivers much-needed underlying consistency, while a highly functional API allows for integrations with a variety of technology vendors for key study processes. This flexibility is vitally important as the number of data sources continues to increase and study designs become more complex.
Over the course of two decades, Mednet has witnessed the rapid change and evolution in the industry. Our team has led efforts to deploy new technologies in complex trial designs. We have partnered with clients to deliver innovative solutions that position teams for clinical trials today and tomorrow. To learn more about the iMednet platform and our approach to decentralized trials and other study designs, contact us.