At the 2024 SCOPE Summit, AbbVie’s Digital Science Head, Michelle Crouthamel, presented compelling case studies on Aleve PM and Bellerophon Therapeutics, demonstrating the transformative power of Digital Health Technologies (DHTs) in clinical trials. Her insights highlighted DHT’s role in enhancing research efficiency and the necessity for standardized industry metrics to evaluate their impact at Abbvie.

Aleve PM and Bellerophon Therapeutics: Case Studies in DHT Implementation

Crouthamel delved into two compelling case studies that showcased the practical benefits and potential of DHTs in clinical trials. The Aleve PM study demonstrated DHTs’ capability to enhance pivotal research by integrating naproxen and diphenhydramine, which notably decreased Wake After Sleep Onset (WASO) in the treatment group compared to the control arm. This use of DHTs facilitated data collection from over 800 participants, showcasing how digital endpoints can efficiently manage large-scale and complex studies while cutting down on costs and duration.

Although Bellerophon Therapeutics’ experience did not culminate in drug approval, it emphasized the value of DHTs in optimizing financial resources in clinical trials. Crouthamel highlighted how digital endpoints significantly reduced trial expenses and the scale of participant cohorts needed. This case illustrated DHTs’ role in minimizing financial risks associated with clinical trials and affirmed the practical applications and advantages of digital technologies in clinical research.

Aligning with Regulatory Agencies: A Strategic Imperative

A key takeaway from Crouthamel’s presentation was the critical nature of regulatory strategy and engagement. At the heart of Abbvie’s strategy was the meticulous crafting of engagement with regulatory bodies. By initiating a continual dialogue with entities like the FDA and EMA through Letters of Intent (LOIs), AbbVie moved beyond mere compliance to active collaboration. These LOIs were not just procedural but strategic, serving as platforms to establish the clinical relevance of their digital measures and to forge a path for integrating DHTs into trial designs from the ground up.

The dual-path approach—customized for sponsors and vendors—exemplified AbbVie’s understanding of the regulatory ecosystem. Sponsors were encouraged to embed regulatory considerations and engagement about DHTs into their trial methodologies early on. At the same time, DHT vendors were encouraged to pursue regulatory qualification pathways, ensuring that their technologies met the rigorous standards expected by the authorities. AbbVie’s proactive stance ensured that agency feedback could be integrated promptly, refining their digital endpoints to efficiently meet clinical and regulatory demands. This strategy streamlined the path to approval and demonstrated a model for accelerating the broader adoption of digital innovations in clinical research.

Addressing Unmet Needs and Managing Change

Crouthamel highlighted the transformative impact DHTs could have on addressing diseases that have long challenged the clinical trial community, such as autoimmune, neurodegenerative, and psychiatric disorders, where traditional diagnostic and monitoring tools fall short. The precision and continuous monitoring offered by DHTs present a new horizon for these conditions, promising more objective and sensitive outcome measures that can detect slight variations in disease progression and patient response to treatment.

However, the adoption of such advanced technologies is often met with skepticism, particularly regarding their perceived intricacies and financial implications. There’s a palpable hesitance within pharmaceutical circles, driven by the fear that integrating sophisticated DHT systems could lead to increased operational complexity and inflated costs. Crouthamel argues that such concerns, while understandable, are not insurmountable. Crouthamel advocates for a rigorous evaluation of DHTs through comprehensive data analysis and stakeholder engagement to illuminate the true value of these technologies. Through transparent communication and demonstrable success stories, AbbVie envisions dispelling doubts and facilitating widespread adoption of DHTs in clinical trials.

The Uncharted Territory of DHT Value Metrics

Crouthamel highlighted a significant hurdle in the journey toward digital integration in clinical trials—the absence of uniform metrics for gauging the effectiveness of DHTs. The current landscape lacks a standardized system to quantify the return on investment or the enhancements in trial efficiency brought about by DHTs, which makes it challenging to communicate the tangible advantages these technologies offer. Crouthamel stresses establishing industry-wide agreements on key performance indicators to bridge this divide.

These metrics would serve as benchmarks for evaluating the success and value of DHT implementations, providing clear evidence of their impact on streamlining trials, reducing costs, and improving patient outcomes. Moreover, establishing such metrics would empower stakeholders to make informed decisions and pave the way for broader acceptance and deployment of DHTs across the sector. Crouthamel’s call to action is for a collaborative effort to define and adopt these metrics, and this consensus on metrics is seen as a cornerstone for the future of clinical research, ensuring that the true potential of digital technologies is recognized and realized by the industry and regulators.

ABCD: The Ethos for Overcoming Digital Implementation Challenges

Crouthamel’s presentation concluded with an ethos that could be a mantra for the industry: the ABCD approach—Agile, Bold, Collaborate, and Beyond Duty. This approach emphasizes the need for agility in adapting to new technologies, boldness in pioneering new methodologies, collaboration across the industry, and a sense of duty that goes beyond the usual call. AbbVie’s focus on discipline and devotion highlights the necessity for passion and commitment in driving the integration of DHTs for superior patient outcomes and fostering a culture of innovation.

Summary: A Call to Action for the Industry

Michelle Crouthamel’s presentation at the 2024 SCOPE Summit marks a pivotal step toward integrating DHTs in clinical trials, highlighting AbbVie’s innovative approaches with Aleve PM and Bellerophon Therapeutics (AbbVie, Aleve, and Bellerophon Therapeutics are not under the same company). Her call for standardized metrics and a collaborative regulatory strategy predicts a future where digital transformation enhances trial efficiency and patient care. Crouthamel’s agility, boldness, and collaboration ethos sets a new standard for the industry’s journey toward digital innovation.

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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.