di , 30/11/2023

Digital Health Technologies (DHTs) have revolutionized the landscape of clinical trials, particularly in neurology research, by enabling the collection of real-world data outside traditional clinical settings. After a decade-long evolutionary process, DHTs grew to facilitate remote patient monitoring, real-time data collection, and advanced analytics, allowing for a more comprehensive and accurate assessment of participants’ health. Furthermore, by fostering connectivity and automating tasks, DHTs reduce administrative burdens, accelerate recruitment, and improve overall trial transparency, ultimately contributing to faster and more reliable drug development.

Evolution and Benefits of DHTs in Neurology Trials

DHTs – like wearables, mobile health apps, and telemedicine platforms – have for example significantly impacted the design and execution of neurology trials. In a recent review paper appeared on Nature, Mittermaier et al. reported a substantial increase in the use of DHTs, from 0.7% in 2010 to 11.4% in 2020, with projections suggesting up to 70% of clinical trials incorporating wearable sensors by 2025. The shift from simple tracking methods to more complex measures like speech and cognition demonstrates the growing sophistication of DHT applications.

The use of DHTs in neurology trials produced consistent benefits on many levels. The continuous remote monitoring facilitated by DHTs allows for the collection of diverse, longitudinal data, offering insights into disease physiology and outcomes. This evolution has given rise to digital phenotyping and the creation of digital twins for precision medicine. The advantages extend beyond research efficiency, with decentralized and virtual trial settings reducing the burden on participants by minimizing travel time and costs.

Challenges and Considerations

While DHTs present promising opportunities, challenges such as the digital endpoint harmonization and the digital divide must be addressed. In particular, the Lancet and Financial Times Commission emphasized the need for investments in digital infrastructure to bridge the gap in internet access and technology literacy, ensuring equitable participation in clinical trials.

Importance is also associated with the need to build a solid and shared regulatory framework; and to generate consensus about data reliability methods. The incorporation of novel digital endpoints requires a standardized evaluation framework. Considerations of trustworthiness, explainability, usability, and transparency are crucial in evaluating Biometric Monitoring Technologies within DHTs. Authentication issues in virtual trials also necessitate innovative solutions, including biometric authentication and continuous user identification through AI models.

Maintaining data quality remains a challenge in real-world settings, with artifacts from the environment, devices, and patient behavior impacting reliability. Strategies for assessing data completeness and developing signal quality indices, as demonstrated for example in epilepsy studies, contribute to enhancing the credibility of DHT-derived measures.

Healthcare Industry Driving Change

Healthcare industry is rapidly becoming an engine of change for the use of DHTs in clinical trials. AstraZeneca has launched Evinova, an healthtech business focusing on providing digital solutions for clinical trials in the life sciences sector. Operating independently within the AstraZeneca group, Evinova offers established digital technology solutions globally, aiming to optimize clinical trial design and delivery. The company will supply solutions to AstraZeneca while extending services to pharma, biotech companies, and clinical research organizations. Evinova’s products, including AI and machine learning algorithms, reduce the time and cost of developing medicines, enhance patient experiences, and support digital remote patient monitoring and digital therapeutics. The portfolio covers clinical development support, automatic costings, and assessments of operational feasibility, along with software for comprehensive clinical program and trial management. Evinova, with support from CROs Parexel and Fortrea, collaborates with Accenture and Amazon Web Services to accelerate industry adoption and expand global reach.

Another example is CliniScout Recruit by Healthware – a digital service for recruiting subjects to clinical trials. It has been used in various studies in Europe with great results. As recruitment is one of the largest single challenges in clinical trials, the benefits are significant. Additionally, another of Healthware’s DHT services for clinical trials is CliniScout ePRO. It improves subject engagement and communication, as well as streamline the collection of real-world and quality-of-life data. The comparison to traditional tools like paper diaries and phone calls is remarkable, which also has been demonstrated in patient surveys of CliniScout users.

Conclusion: Shaping the Future of Clinical Trials with DHTs

In conclusion, the growing utilization of DHTs in neurology trials marks a transformative shift towards decentralized and virtual clinical research. While presenting unprecedented opportunities for data collection and trial efficiency, careful consideration must be given to address challenges, ensuring equitable access and maintaining data reliability. As DHTs continue to shape the future of clinical trials, collaborative efforts between stakeholders, regulatory bodies, and technology developers are essential to maximize their potential benefits and minimize potential pitfalls.