5 Strategies for Bridging the Sponsor-Site Tech Divide

In today's high-stakes clinical trial and drug development environment, technology has become a driving force for streamlining workflows, ensuring data integrity, and optimizing the experience of all humans involved. However, a significant disconnect often exists between the technologies selected by sponsors and the actual needs of site personnel and trial participants. This article explores the critical importance of understanding and addressing the challenges of site staff in using clinical trial technologies, focusing primarily on electronic clinical outcome assessment (eCOA) systems and electronic consent (eConsent) tools.

This analysis aims to help sponsors bridge the gap between selected technologies and site needs by examining the current state of technology adoption, identifying key pain points, and offering insights into more informed decision-making processes. A recent, comprehensive survey¹ of 100 clinical trial site personnel forms the foundation of these insights, providing a clear picture of the challenges and opportunities in this crucial area of clinical research.

The technology tightrope: Balancing sponsor needs and site realities

The survey results reveal a stark reality: only 35% of respondents reported a strong alignment between sponsor-required technologies and the sites' actual needs and experiences. This misalignment can result in inefficiencies, errors, and frustration among site staff, ultimately affecting the quality and speed of their work.

When asked to identify the biggest issues keeping them up at night when conducting a clinical trial, survey participants identified participant recruitment and retention (75%), timelines and delays (51%), and drug safety and tolerability (46%). These challenges underscore the need for effective, user-friendly technologies that can address concerns while meeting the needs of all stakeholders.

eConsent: A digital revolution gaining momentum

The top benefits of eConsent identified by respondents include reduced errors in capturing consent (55%), improved regulatory compliance (38%), and improved efficiency and time savings (37%). However, areas for improvement were also noted, such as better integration with other eClinical systems (54%) and simplified content with more visual aids and explanations (49%).

While electronic consent systems are gaining traction, traditional paper consent still dominates the field. The survey results illustrate this trend. When asked approximately what percentage of the studies they have worked on in the past 12 months have used eConsent vs. paper consent, site personnel responded:

• 62% of studies used paper consent
• 38% of studies utilized electronic consent systems

Among eConsent users, the majority (58%) used sponsor-provided systems, 36% utilized site-owned systems, 5% were unsure of the type used.

eCOA: Widespread adoption, persistent challenges

Survey respondents acknowledged numerous benefits of electronic clinical outcome assessment systems. The top advantages cited were more efficient data collection (68%), improved overall operational efficiency at sites (57%), and simplification of complex questionnaires (41%). Despite these benefits and wider adoption compared to eConsent, challenges persist in eCOA implementation.

The survey revealed varied usage patterns among respondents over the past 12 months. The majority (56%) reported using two or three eCOA platforms, while 10% utilized four or more. A smaller portion (21%) relied on just one platform, and 13% did not use any eCOA platforms at all.

• Key concerns regarding eCOA use at sites include:
• Lack of integration with other eClinical systems (50%)
• Difficulties in educating participants on device and ePRO system use (47%)
• Systems being too complex for patients to navigate (37%)
• Notably, only 36% of respondents felt that the eCOA platforms they were required to use adequately met their needs and experiences.

The power of user-centric design in clinical trial technology

The revelation of a mismatch between provided technologies and user needs in clinical trials highlights the importance of user-centric design. This approach improves efficiency, data quality, and the overall trial experience for both staff and participants.
Key benefits include:

• Improved Efficiency. Aligning technologies with site workflows reduces administrative time, allowing more focus on patient care.
• Enhanced Data Quality. Intuitive systems minimize errors and boost compliance.
• Better Patient Experience. Less cumbersome technologies enable staff to dedicate more attention to participants.
• Increased Adoption. Technologies meeting user needs are more likely to be fully utilized.
• Streamlined Training. User-friendly systems often require less intensive training.

By prioritizing user-centric design, clinical trial technology can better serve its intended purpose, leading to more successful and efficient trials while improving the experience for all stakeholders involved.

Strategies for bridging the technology gap

To address the current gaps in technology alignment, sponsors can implement several key strategies:

1. Involve Site Personnel in Technology Selection. Only 20% of survey respondents indicated that sponsors frequently or always seek site input when selecting eCOA platforms. Expanding site involvement can provide valuable insights into the practical implications of different technologies.
2. Prioritize Integration and Interoperability. With 50% of respondents citing lack of integration as a top concern for eCOA systems, interoperability should be a key consideration in technology selection.
3. Invest in Comprehensive Training Programs. Only 28% of respondents felt very well or expertly trained on eCOA platforms. Comprehensive, ongoing training programs are essential for ensuring effective use of provided technologies.
4. Emphasize User-Friendly Interfaces. More than half (51%) of respondents indicated a need for greater user-friendliness in eCOA platforms. Prioritizing intuitive, easy-to-navigate interfaces can significantly reduce the learning curve and improve overall experience.
5. Continuously Gather and Act on Feedback. Implementing a system for ongoing feedback from site personnel can help identify issues early and guide continuous improvement of clinical trial technologies.

The ripple effect: Benefits for all stakeholders

When sponsors prioritize the needs of site personnel and participants in their technology selections, the benefits ripple through all aspects of the clinical trial:

• Site Personnel - Reduced administrative burden, increased job satisfaction, and more time for patient care
• Participants - Improved experience, potentially leading to better retention rates and higher-quality data submission
• Sponsors - More efficient trials, higher quality data, and potentially faster time to market for new treatments
• Healthcare System - More effective trials can lead to faster development of new treatments, benefiting patients worldwide

A call for collaborative innovation

As the clinical trial landscape transforms, sponsors who focus on understanding and meeting the needs of site personnel and participants through thoughtful technology choices will be best positioned for success. By fostering robust partnerships between sponsors, sites, and technology providers, we can build a more efficient and participant-friendly clinical trial ecosystem that accelerates the development of life-changing treatments.

The future of clinical research hinges on advancing scientific capabilities while ensuring that technologies empower those at the heart of trials. Achieving this balance will drive success and innovation universally, ultimately benefiting patients and advancing medical science more rapidly and effectively than ever before.

Drew Bustos, chief digital officer, YPrime

Reference

1. A Sponsor's Guide to Next-Gen Trials: Leveraging Site Insights for Smarter Technology Decisions, Y-Prime, LLC, 2024. https://www.yprime.com/site-report-insights-for-clinical-trial-sites-sponsors/