In this interview, we speak with Dr. Stephen Deacon, Chief Scientific Officer at Pharmanovia, about the shift towards decentralized clinical trials (DCTs).Ā With over 33 years of experience, Stephen discusses the benefits, challenges, and future directions of clinical trials, emphasizing digital innovation, collaboration, and patient-centricĀ approaches.
Moe Alsumidaie: Why have decentralized trials become more prevalent, and what are theirĀ 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 recruitmentĀ timelines.Ā The pandemic accelerated the adoption of remote monitoring and data collection, demonstrating the feasibility and importance of theseĀ methods.Ā
In terms of the benefits, decentralized trials enhance diversity and inclusion by enabling participation from individuals in varied geographical locations who might otherwise lackĀ access.Ā This inclusivity leads to more diverse
and meaningful data, optimizing patientĀ care.Ā Additionally, decentralized trials improve data quality through real-time collection, offering richer insights into how medicines perform in everydayĀ settings.Ā This approach also reduces patient burden, making participation more convenient and less stressful, decreasing studyĀ dropouts.Ā 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 improveĀ outcomes?
Stephen Deacon: Decentralized trials provide a more nuanced understanding of patientsā 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 ofĀ trials?
Stephen Deacon: Collaboration is essential for optimizing medicines and improving patientĀ outcomes.Ā As a life cycle management company, we gather real-world evidence through partnerships with clinical research organizations, digital companies, and patientĀ organizations.Ā These collaborations enable us to collect high-quality data and expedite the process of bringing medicines toĀ market.Ā By leveraging the expertise of various organizations, we can tap into innovative ideas and tailor our approaches to best serve people and healthcareĀ providers.Ā 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 clinicalĀ trials.
Moe Alsumidaie: What are the primary challenges in clinical trials, and how can they beĀ 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 trialĀ efficiency?
Stephen Deacon: Our business model focuses on revitalizing established medicines and promoting sustainability by reducing the need for resource-intensive new drugĀ development.Ā By reformulating existing medicines, we can decrease waste and expedite time toĀ market.Ā For instance, reducing the number of tablets needed per day through sustained-release formulations minimizes packaging and shippingĀ requirements.Ā Decentralized trials contribute to sustainability by reducing clinic visits and associated carbonĀ emissions.Ā Remote data collection minimizes the need for physical infrastructure and paper-based processes, allowing us to deliver care more efficiently andĀ sustainably.Ā This approach aligns with our goal of doing more with less, benefiting people and theĀ environment.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.