This interview features the innovative world of decentralized clinical trials (DCTs) with insights from Darcy Forman of Science 37. This discussion delves into the complexities and pioneering strategies of DCT. We explore how Science 37’s unique Metasite model navigates the evolving landscape of FDA regulations, balances patient-centricity with data integrity, and harnesses digitization to redefine clinical research. This conversation promises to shed light on the future trajectory of DCTs and the pivotal role of Science 37 in shaping this dynamic field through its virtual site.
Moe Alsumidaie: With the FDA’s guidelines not explicitly covering aspects like investigator training, how does Science 37’s Metasite model ensure compliance?
Darcy Forman: Our approach is intricately aligned with FDA guidelines, mirroring traditional clinical trial sites’ requirements but in a decentralized context. Our primary investigator is responsible for overall operations, supplemented by a team of investigators and healthcare professionals. These individuals are meticulously trained based on a decision tree we developed, which discerns their roles and the associated training needed. This method ensures compliance, leveraging our extensive discussions and coordination with the FDA.
Moe Alsumidaie: What unique challenges does Science 37 face in training and overseeing staff in decentralized clinical trials, and how do you address these?
Darcy Forman: The decentralized nature of our trials necessitates a comprehensive approach to staff training and oversight. Our teams are spread across various regions, requiring a robust learning management system to ensure consistent training. We’ve developed electronic systems to track completion and compliance with training protocols. One challenge is coordinating activities across time zones, necessitating advanced scheduling tools and strategies.
Moe Alsumidaie: With the ever-changing regulatory landscape, how is Science 37 adapting its model in anticipation of future FDA guidelines?
Darcy Forman: We’re in a unique position where our current model aligns closely with the FDA’s draft guidance. Minor adaptations might be needed, such as refining our documentation to meet specific FDA requirements. An example is ensuring our task lists and delegation of authority logs are in sync with FDA expectations. We’re actively preparing for potential changes based on feedback from the FDA and industry comments.
Moe Alsumidaie: How does Science 37 balance the focus on patient-centricity with the imperative of maintaining high-quality scientific data?
Darcy Forman: Patient centricity is at the heart of our model. We strive to provide trial opportunities to patients who otherwise might not have access, particularly those who can’t easily travel to traditional trial sites. This approach includes awareness initiatives and adapting trial execution to suit patient needs. For instance, we bring the trial to the homes of patients with severe illnesses or comorbidities. Our robust technology infrastructure is crucial here, offering real-time data visibility and enhanced investigator oversight, thus ensuring data quality and patient safety.
Moe Alsumidaie: Considering the ICH E6 (R3)’s emphasis on digitization, how does the Metasite model align with this approach?
Darcy Forman: Digitization is a cornerstone of our operations. We function in a paperless environment, collecting and managing all patient data digitally. This approach ensures efficient data handling and seamless integration into the sponsors’ Electronic Data Capture (EDC) systems. We continuously evolve to align with ICH guidelines, ensuring our digital infrastructure supports quality and safety enhancements.
Moe Alsumidaie: Could you provide an example of a specific operational challenge in a decentralized trial and how you overcame it?
Darcy Forman: A prominent challenge in DCTs is managing logistics, especially concerning supply chain management for lab kits and Investigational Medicinal Products (IMPs). An example is ensuring the timely delivery of these items to patients’ homes, coordinating with nurses’ schedules and investigator availability. We’ve developed sophisticated scheduling systems and contingency plans to manage these complexities, although factors like weather disruptions can still pose challenges.
Moe Alsumidaie: How do you see the future of decentralized clinical trials evolving?
Darcy Forman: The future of DCTs lies in making clinical research more accessible and patient-friendly. Our model is about leveraging the Metasite as a site to reach the patient rather than vice versa. This approach significantly reduces the burden on patients and increases trial accessibility. We’re focusing on distinguishing ourselves in the industry by enhancing our capabilities to bring research directly to patients’ homes, simplifying their trial participation.