DPHARM (Disruptive Innovations to Clinical Research) 2024 brought together senior clinical operations executives and innovative thought leaders to unveil the latest innovations in modernizing clinical trials. I had the opportunity to present on the challenges and opportunities of decentralized clinical trials (DCTs) in clinical research.

As the head of Evidence Development at UBC, I am actively involved in implementing DCT elements into our late-stage research programs. Through our experiences, we have learned valuable lessons about the real-world challenges of DCTs, and how to optimize hybrid study designs for more effective evidence generation.

Understanding the Limitations

One of the key challenges we have encountered is the mismatch between the hype surrounding DCTs and the reality of their implementation. While DCTs offer certain advantages such as access to a vastly expanded patient population, these trial designs also introduce new challenges that the clinical research infrastructure is not accustomed to.

One common misconception about DCTs is that they are inherently faster and less expensive than traditional site-based trials. The success of a DCT depends on careful planning and execution, including the centralization of a significant amount of work previously distributed across multiple sites. The time and resources required for this framework cannot be underappreciated.

Technology and Patient Preferences

Another challenge DCTs face is the fragmented technology landscape and the varying patient preferences for DCTs. While technology can enable remote participation, it can also add complexity and burden for both patients and investigators.

Moreover, not all patients are equally comfortable with the concept of remote participation in clinical trials. Some may prefer traditional in-person interactions with healthcare providers, while others may face barriers such as limited access to technology or internet connectivity.

Optimizing Hybrid Study Designs

To address these challenges and maximize the benefits of DCTs, we believe that a hybrid approach is often the most effective. This involves combining elements of traditional site-based trials with decentralized components, such as remote patient monitoring, e-consent, and virtual visits.

By carefully considering the specific needs of the study and the preferences of patients, we can design hybrid studies that are both efficient and patient-centric. This thoughtful approach will overcome the limitations of DCTs while still leveraging their potential advantages.

DCTs or, more aptly, 'hybrid modernized study designs' offer the promise to enhance clinical research, but it is essential to approach them with realistic expectations. By understanding the challenges and limitations of what is often called DCT and carefully designing hybrid studies, we can harness their potential to accelerate drug development and improve patient outcomes.

About UBC

UBC is the leading provider of evidence development solutions with an expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. Bringing over 30 years of experience, UBC is uniquely positioned to develop diversity action plans, end-to-end integrated evidence generation strategies, identify fit-for-purpose data sources, operationalize planned studies, and ensure regulatory-grade, publishable outputs.

About the Author

Aaron Berger serves as Senior Vice President and Head of Evidence Development Solutions for UBC. He leads a multi-disciplinary team that designs and executes modernized solutions leveraging forward-leaning technology and research designs that deliver fit-for-purpose evidence on the safety and effectiveness of treatments for patients. He is responsible for the development of real-world evidence technology architectures and modernized research solutions to drive greater insight into the safety profile and value proposition of medicines.

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