Why Should Companies Use Digital Endpoints Across Clinical Development?

The traditional clinical trials model is facing scrutiny. Marked by high costs ranging from $1 billion to $2 billion, lengthy timelines extending five to ten years and success rates falling below ten percent, there is a pressing need for reform. These daunting figures highlight the necessity for innovative solutions that can accelerate the journey of new drugs from the lab to patients.

VivoSense, a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research.

In this Xtalks Spotlight edition, Xtalks spoke with Dr. Ieuan Clay, Director of Science at VivoSense, who is involved in integrating validated and verified DHTs into clinical research.

Our discussion delved into the potential of DHTs to reshape how clinical trials are conducted, making them not only faster and less costly but also more patient-centric and reflective of real-world outcomes.

Dr. Clay’s insights offer a view into the changing landscape of clinical trials, where digital endpoints and wearable sensors are emerging as drivers of change in drug development.

The Case for Digital Endpoints in Clinical Trials

Dr. Clay outlines the benefits of using digital endpoints from wearable sensors in clinical trials. He points out that traditional methods provide only sporadic glimpses of a patient’s condition, typically during occasional hospital visits. This method does not accurately or continuously capture the daily realities and challenges of patients, particularly those with slowly progressing conditions like neurological or rare diseases.

“At VivoSense, we don’t prescribe a one-size-fits-all approach. It’s very much about what you are trying to achieve in your particular program or with your portfolio.”

— Dr. Clay

Digital measures, however, can bridge this gap. By providing real-time, objective data from patients’ everyday lives, these tools offer a clearer picture of disease progression and patient well-being. Dr. Clay highlights that these technologies not only improve clinical trial data but also foster greater patient engagement and can improve quality-of-life assessments — factors increasingly valued by regulatory bodies like the US Food and Drug Administration (FDA).

Moreover, Dr. Clay mentions the economic benefits of digital measures. A recent publication by the Tufts Center for the Study of Drug Development, Tufts University, and the Digital Medicine Society, among others, concludes that the use of digital endpoints in clinical trials can reduce trial duration and size, providing substantial extra value and high return on investment (ROI) to sponsors developing new drugs.

Integrating DHTs Across Drug Development Phases

Dr. Clay says that DHTs hold roles across all phases of drug development, with each stage offering unique opportunities for their implementation:

• Phase I trials: In these initial stages focused on safety, DHTs offer critical insights. Wearable sensors and digital tools enable continuous participant monitoring, providing real-time data on physiological responses and potential adverse events. This continuous monitoring may detect subtle or unexpected drug effects that might go unnoticed with infrequent clinical visits or conventional, intermittent monitoring techniques.
• Phase II trials: As trials progress to Phase II, focusing on efficacy, DHTs may enhance decision-making by providing detailed data, enabling quicker evaluations of a drug’s effectiveness. This phase also starts to incorporate patient-centric endpoints, establishing crucial evidence early on. Digital tools can shape a trial’s progression and ensure it is built on a foundation of meaningful, patient-relevant data.
• Phase III trials: In these advanced stages, focused on confirming efficacy and monitoring side effects in larger populations, DHTs may support market authorization and label claims. Real-world data from digital tools not only strengthens the evidence for regulatory approval but also improves the drug’s market positioning by substantiating its impact on quality of life and daily functioning.
• Phase IV and beyond: Post-market surveillance greatly benefits from the ongoing use of DHTs, which provide continuous insights into a drug’s long-term effects and efficacy in the general population. This phase focuses on collecting real-world evidence, and DHTs, enabling vast data collection with minimal intrusion, are well-suited for this purpose.

By integrating DHTs from initial safety assessments to post-market surveillance, the drug development process may become more efficient and responsive to patient needs. This approach can speed up development and improve data quality, potentially leading to more effective and personalized therapies.

Practical Considerations for Implementing DHTs

To integrate DHTs into clinical trials, various technical, strategic and patient-focused aspects must be first addressed. This process involves a careful understanding of the goals and challenges unique to each trial.

Here are several key areas, outlined by Dr. Clay, that need thorough consideration to ensure that DHTs are successfully implemented:

• Early engagement and planning: Early participation in the planning process is essential to ensure DHTs meet the study’s specific needs. This involvement helps decide whether to use established measures or develop new tools.
• Technology selection: Choosing the appropriate DHT involves a thorough assessment of the health outcomes to be measured and the technology’s capacity to capture them accurately. It’s also important to consider the reliability and validity of the devices for specific endpoints.
• Patient-centric design: Participants should find the technology easy to handle, reducing both physical and psychological strain, particularly for those dealing with significant health issues. It is crucial to design devices with simplicity in mind and ensure they integrate smoothly into patients’ daily routines. The Digital Measures That Matter to Patients framework can offer valuable guidance in achieving these goals.
• Symptom-to-sensor mapping: Precise mapping ensures that DHTs measure intended health outcomes in ways that are clinically meaningful and relevant to the patient population.
• Regulatory considerations: It’s important to ensure that digital measures meet regulatory standards and demonstrate their relevance and reliability to regulatory bodies like the FDA or the European Medicines Agency (EMA).
• Foundational research and validation: When considering novel digital measures, foundational research to establish their validity and relevance is essential. This may include preliminary studies to understand the health impacts most significant to the patient population.

Through these practical considerations, the integration of DHTs into clinical trials can be optimized to enhance data quality, patient engagement and overall trial efficiency.

Future Directions and Industry Adoption Goals

Looking ahead, Dr. Clay is optimistic about the trajectory of DHTs in clinical trials. The field is driven by technological advancements and a stronger consensus among stakeholders — including regulators, patient advocacy groups and trial sponsors — on the importance of patient-centric measures.

Dr. Clay mentions the rapid advancement in technologies, notably multi-sensor devices, which can collect more detailed data sets. These devices allow simultaneous monitoring of various symptoms — like physical activity, sleep patterns and psychological states — offering a comprehensive view of a patient’s health and treatment response.

He also points out the growing regulatory recognition for DHTs, with entities like the FDA and EMA increasingly qualifying digital measures for use in clinical trials. This support is crucial for encouraging the broader adoption of DHTs, confirming their legitimacy and value in the regulatory review process.

In addition, standardizing DHT use is supported by frameworks and guidelines developed by organizations like the Digital Medicine Society, the Clinical Trials Transformation Initiative (CTTI) and the Foundation for the National Institutes of Health (FNIH). These guidelines provide a roadmap for integrating digital measures into clinical trials effectively.

Dr. Clay says that clinical trial frameworks can be transformed to integrate DHTs, making them more aligned with real-world patient experiences. This shift in clinical trials, while still evolving, has promise to address longstanding inefficiencies and improve the path from laboratory to life-changing therapies.

This article was created in collaboration with the sponsoring company and the Xtalks editorial team.