In this interview, we speak with Dr. Stephen Deacon, Chief Scientific Officer at Pharmanovia, about the shift towards decentralized clinical trials (DCTs). With over 33 years of experience, Stephen discusses the benefits, challenges, and future directions of clinical trials, emphasizing digital innovation, collaboration, and patient-centric approaches.

Moe Alsumidaie: Why have decentralized trials become more prevalent, and what are their benefits?

Stephen Deacon: The shift towards decentralized trials is mainly due to the persistent challenge of patient recruitment, with over 80% of trials failing to meet recruitment timelines. The pandemic accelerated the adoption of remote monitoring and data collection, demonstrating the feasibility and importance of these methods. 

In terms of the benefits, decentralized trials enhance diversity and inclusion by enabling participation from individuals in varied geographical locations who might otherwise lack access. This inclusivity leads to more diverse

Stephen Deacon, Chief Scientific Officer at Pharmanovia

and meaningful data, optimizing patient care. Additionally, decentralized trials improve data quality through real-time collection, offering richer insights into how medicines perform in everyday settings. This approach also reduces patient burden, making participation more convenient and less stressful, decreasing study dropouts. I personally experienced this when my mother raised concerns over a few logistical challenges when participating in an on-site trial. Potential stressors for people which included basic elements such as the time for commute were front of her mind which are easily alleviated by decentralized clinical trials.

Moe Alsumidaie: How can data from DCTs bring greater insights and improve outcomes?

Stephen Deacon: Decentralized trials provide a more nuanced understanding of patients’ experiences by capturing data in real-world settings. This approach allows for continuous monitoring through wearables and apps, offering insights that traditional site-based trials might overlook. While specific clinical assessments, like scans, must occur in clinics, a significant amount of data can be collected remotely. This flexibility supports a tailored approach to data collection, accommodating individual patient needs. For example, data collection can involve community nurses visiting homes or collecting postal samples, ensuring inclusivity for patients without digital access. This shift from a one-size-fits-all model to a personalized approach enhances data quality and supports informed decision-making, ultimately improving patient outcomes.

Moe Alsumidaie: How can collaboration improve the success and scalability of trials?

Stephen Deacon: Collaboration is essential for optimizing medicines and improving patient outcomes. As a life cycle management company, we gather real-world evidence through partnerships with clinical research organizations, digital companies, and patient organizations. These collaborations enable us to collect high-quality data and expedite the process of bringing medicines to market. By leveraging the expertise of various organizations, we can tap into innovative ideas and tailor our approaches to best serve people and healthcare providers. This collaborative model is becoming increasingly prevalent in the industry, as it allows for integrating diverse skills and perspectives, enhancing the scalability and success of clinical trials.

Moe Alsumidaie: What are the primary challenges in clinical trials, and how can they be navigated?

Stephen Deacon: Diversity and inclusion are critical challenges, with a growing emphasis on ensuring appropriate trial representation. Decentralized trials help address these issues by breaking down geographical barriers, but additional efforts are needed to improve clinical trial literacy and awareness. Recruitment and retention remain significant concerns, particularly in rare disease spaces with smaller patient pools. Digitalization aids in reaching more patients, but we must ensure access for those without digital tools. Regulatory complexities, especially in global trials, can delay approvals, impacting patient access to treatments. Collaborating with regulatory authorities is crucial to streamline processes and meet patient needs more efficiently. For example, the new European clinical trial regulation aims to simplify the application process across multiple countries, demonstrating a step forward in addressing these challenges.

Moe Alsumidaie: How can life cycle management support sustainability and trial efficiency?

Stephen Deacon: Our business model focuses on revitalizing established medicines and promoting sustainability by reducing the need for resource-intensive new drug development. By reformulating existing medicines, we can decrease waste and expedite time to market. For instance, reducing the number of tablets needed per day through sustained-release formulations minimizes packaging and shipping requirements. Decentralized trials contribute to sustainability by reducing clinic visits and associated carbon emissions. Remote data collection minimizes the need for physical infrastructure and paper-based processes, allowing us to deliver care more efficiently and sustainably. This approach aligns with our goal of doing more with less, benefiting people and the environment.

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Moe Alsumidaie, MBA, MSF, is founder and Chief Editor of Vanguard Publications, which publishes Clinical Trial Vanguard, Pharma Vanguard and BullScope, and Head of Research at CliniBiz. He has two decades in clinical trial operations and data science, with earlier roles at Genentech, Abbott Vascular and Stanford University Medical Center, and is a guest lecturer in clinical trial sciences at Rutgers University.