In an insightful discussion, Tom White, Chief Product Officer of Nye Health, highlights the company’s innovations in clinical trial digital health for UK clinical trials. Emphasizing the importance of their partnership with Roche, White discusses how artificial intelligence (AI) and real-world data are revolutionizing healthcare solutions. He touches on Nye Health’s commitment to data privacy, the significance of interoperability, and the role of AI in improving clinical trial efficiency and patient engagement. White’s insights reveal Nye Health’s crucial impact on the future of clinical research and patient care.

Moe Alsumidaie: Can you explain how the strategic partnership with Roche influences Nye Health’s product roadmap, especially regarding AI and real-world data?

Tom White: The strategic partnership between Nye Health and Roche has been a catalyst for refining our approach towards developing and integrating advanced technologies, particularly artificial intelligence (AI), in our healthcare solutions. By leveraging AI, we aim to transform the vast volumes of real-world data we collect into actionable insights. This alliance also emphasizes the importance of integrating the patient perspective into the pharmaceutical landscape, an overlooked facet. The insights from real-world data through AI applications enable a more nuanced understanding of patient behaviors, treatment outcomes, and disease progression. This integration is key in advancing clinical research, enhancing drug development processes, and delivering superior patient care. In essence, our strategic partnership with Roche propels us towards realizing the potential of AI in clinical trials, making significant strides in developing innovative solutions that are both impactful and aligned with the future direction of medical research and patient management.

Moe Alsumidaie: How does Nye Health address the challenges related to data privacy, security, and regulatory compliance in product development?

Tom White: Nye Health’s commitment to addressing the challenges related to data privacy, security, and regulatory compliance in product development is foundational to our operations. By adhering to stringent standards, particularly in integrating NHS data, we go beyond simply meeting General Data Protection Regulation (GDPR) requirements to exceed them. We are also preparing for medical device classification, demonstrating our commitment to upholding privacy and compliance, as it involves rigorous scrutiny of our products and services to ensure they meet the highest safety and efficacy standards for medical use. Moreover, Nye Health’s

Tom White Chief Product Officer Nye Health

proactive approach to regulatory compliance involves a continuous review and adaptation process in response to evolving legal and industry standards. This agility allows us to anticipate and effectively navigate the complexities of global data protection laws, ensuring our products remain at the forefront of compliance.

Moe Alsumidaie: Interoperability is a significant concern in clinical trial digital health. How is Nye Health working to ensure seamless data integration and usability in clinical trials?

Tom White: Nye Health recognizes the critical importance of interoperability in the clinical trial digital health ecosystem, especially in clinical trials where data integration and usability can significantly impact research outcomes. In addressing this challenge, we actively explore our role within the clinical trial framework, assessing the benefits of serving as a standalone data endpoint or a comprehensive platform that facilitates trial management. Our efforts include developing robust APIs and employing standardized data formats to ensure our platform can easily integrate with other systems, fostering a cohesive ecosystem where data flows freely and securely between all stakeholders involved in clinical trials. Additionally, we are actively engaging with industry standards and participating in collaborative initiatives to help shape the future of clinical trial digital health interoperability.

Moe Alsumidaie: What trends and technologies will significantly impact digital health technologies in clinical trials?

Tom White: Integrating AI into digital health transforms clinical trials, enhancing patient engagement and retention—key to research success. AI analyzes data to detect engagement and compliance indicators, enabling preemptive actions to prevent dropouts. Additionally, its predictive analytics from clinical trial digital health applications can anticipate trial outcomes from early data, guiding decisions on trial adjustments or termination to optimize resources and speed up treatment availability. AI also streamlines data collection and analysis, revealing hidden trends that can improve data quality or endpoint detection. This evolution towards AI-enhanced clinical trial digital health solutions promises greater efficiency and a patient-centered approach to clinical research.

Moe Alsumidaie: What unique offerings can you provide to benefit clinical trial strategies?

Tom White: Nye Health distinguishes itself in the digital health sector, especially for those conducting clinical trials in the UK, by providing unmatched access to NHS data. This access enables us to improve patient recruitment, stratification, and engagement, making trials more efficient and based on detailed, accurate health records. Beyond integrating data, our approach involves patients and sponsors in developing digital health solutions, ensuring they meet actual needs through a co-creation strategy. This method boosts engagement by tailoring solutions to trial participants’ specific challenges and preferences, improving trial outcomes’ quality and reliability. Additionally, we view sponsors as partners in innovation, fostering a collaborative development of digital health solutions that align with each trial’s unique objectives and demands. By engaging with sponsors from the idea phase through to the deployment and feedback stages, our platform and services adapt to real-world insights and evolving trial requirements.

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Moe Alsumidaie Chief Editor
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.