Decentralized Clinical Trials: The Future Of Clinical Research Is Here

Innovations in clinical trials are needed to significantly impact and improve key pain points in operational execution. Improvements in technologies and methods to drive clinical trial innovations have focused on the incorporation of decentralized clinical trials (DCTs)—also sometimes referred to as “remote,” “hybrid,” “virtual,” or “patient-centric” trials (Medidata, 2020). The COVID-19 pandemic has significantly accelerated the adoption of DCTs, which allowed sponsors and CROs to quickly virtualize many trial activities, including remote monitoring, telehealth visits, electronic consent (eConsent), electronic patient reported outcomes (ePRO), electronic clinical outcome assessments (eCOA), and use of wearables/sensors. The uptake in DCTs is expected to continue in a post-COVID-19 world due to the experience gained during the pandemic.

The major benefits of DCTs include their potential to enhance the patient trial experience, deliver medicines to market faster, drive value demonstration, and offer greater time, and cost efficiencies. These improvements may finally provide a realistic solution for offsetting the ever-increasing costs associated with drug and device development (Apostolaros, 2019; DiMasi, 2016). However, to reap the full benefits offered by DCTs, it is imperative that the patient experience is optimized by ensuring that novel technologies deployed in a DCT offer convenience, reduce burden, and are easy to use.

Since DCTs are independent of geographic location and are implemented using digital health technologies and mobile/ local healthcare providers, they have the potential to eliminate many of the constraints associated with traditional trial designs, including difficulties with recruitment and retention of sites and participants, and challenges in obtaining a wider variety and more frequent data points. By reducing the burden of participation, DCTs have the potential to increase the size of the patient pool for recruitment and shorten enrollment timelines. Improvements in data quantity and quality are more easily achieved, as measurements can be more frequent (e.g., sensors/wearables that take measurements 24 hours, 7 days a week), more robust (e.g., data collection can be integrated into a patient’s real-life routine), and more comprehensive. Combining disparate data streams—such as real-world data in combination with clinical trial data—offers the opportunity to develop highly comprehensive patient profiles that are more informative with regards to how patients are affected by drugs and diseases.

It is expected that the use of DCT technologies within trials will increase, with estimations that 70% of trials will use one or more of these digital health technologies within the near future (Myshko, 2019). Further, by combining DCT capabilities—including eConsent, ePRO, eCOA, virtual visits, sensors/wearables, and patient registries—into a single unified platform, study teams can work off of a single data architecture that provides streamlined workflows, and can shorten time to study close and database lock by leveraging automated and intelligent tools that employ a risk-based approach to data management. Ultimately, unified and flexible DCT platforms can drive value demonstration of new therapies, which can increase patient access and differentiation in the marketplace.

This white paper provides an introduction to DCTs and summarizes the state of the industry from the perspective of different stakeholders, including the pharmaceutical and medical device industries, regulators across the world, and patients.

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