Season 2 Episode 7: Sites Are Voicing Their Concerns, But Are We Listening?

This podcast episode, hosted by Veeva Systems Inc, provides a critical examination of the challenges faced by clinical trial sites, emphasizing the detrimental effects of inconsistent technology and poor industry communication on site operations and patient care. Featuring Vivienne van de Walle, a medical director and research site founder, and Bree Burks, Veeva's VP of Strategy for Site Solutions, the discussion centers on the urgent need for sponsors, CROs, and vendors to genuinely listen to sites, simplify processes, and integrate technology more effectively to support, rather than hinder, clinical research. The conversation is framed around the idea that research happens at the site, making site feedback paramount for industry improvement.

A major theme explored is the overwhelming technological burden placed on sites, which Dr. van de Walle vividly describes as an "escape room" due to the multitude of vendors, codes, URLs, and activation processes required for a single trial. This complexity takes time away from patient care, which sites view as their primary pain point. Beyond technology, universal challenges include staffing shortages—often because young professionals are unaware of clinical research as a viable career path—and persistent issues with budgeting, finances, and timely payments. The speakers stress that technology should be a supportive tool, not the focus of the trial itself, and criticize the current practice of providing training without allowing sites hands-on experience until the first patient is present.

The discussion pivots to the critical need for consistency and interoperability. Sites often deal with different activation methods (e.g., e-diaries, iPads, portals) even within trials run by the same service provider, highlighting a lack of internal coordination among project teams. A key procedural flaw identified is the lack of transparent issue tracking; site deviations are often logged for problems caused by vendors, couriers, or malfunctioning technology, leading to unfair negative evaluations of the site's performance. Dr. van de Walle shared a crucial insight: vendors often assume they are delivering good service if sites resolve issues internally without calling the help desk, reinforcing the need for a transparent, industry-wide issue log that tracks problems back to the responsible party (vendor, courier, or sponsor).

Looking toward the future, the speakers advocate for significant procedural and technological shifts. Bree Burks emphasizes embedding clinical trials into routine healthcare to increase patient access and reduce the variation in how trials are conducted. Dr. van de Walle introduced a successful operational model at her site where staff are assigned specialized roles (e.g., e-diaries, data entry) based on their aptitude, rather than forcing one coordinator to handle all technologies from A to Z. The ultimate hope is to move away from a "tick box" compliance culture toward sensible, quality-focused evaluations and to achieve true system communication, allowing seamless data flow across different applications and stakeholders, similar to consumer technology standards.

Key Takeaways:

• Technology Overload is a Major Pain Point: Clinical trial sites face an overwhelming "escape room" scenario due to managing a multitude of disconnected vendor systems, requiring excessive time spent on logins, codes, and activations that detracts from patient care.
• Lack of Standardization and Consistency: Even within the same vendor or sponsor, trials often use different methods for activating patient technology (e.g., e-diaries via iPad vs. portal), creating unnecessary complexity and friction for site staff.
• Need for System Interoperability: The industry must move beyond siloed systems and enable technology platforms to communicate seamlessly, allowing for a "one entry, read many times" data flow, which is crucial for efficient data engineering and site operations.
• The Deviation Log Problem: Current regulatory processes unfairly penalize sites by logging deviations for issues caused by external factors like vendor software bugs, late drug delivery, or courier errors, masking the true source of operational failures.
• Mandate Transparent Issue Tracking: The industry needs a transparent, shared issue log (or deviation log) that tracks problems back to the responsible party (sponsor, CRO, vendor, or courier) to ensure accountability and drive necessary software or process improvements.
• Technology Training Must Be Hands-On: Sites often receive training but lack practical, hands-on experience with new systems until the first patient visit, turning the initial patient into a "trial in the trial" and weakening the patient-caregiver relationship.
• Shift Staffing Models: Sites can optimize efficiency and staff satisfaction by moving away from the traditional model of one coordinator handling all aspects (A-to-Z) of a trial, instead assigning specialized roles based on staff aptitude (e.g., one person excels at e-diaries, another at data entry).
• Address Patient Access and Centricity: Current technology fails patients by making it nearly impossible to easily find and screen for clinical trials; true patient centricity requires designing technology that prioritizes simple access and communication.
• Avoid Assumptions about Technology Literacy: Sponsors and vendors must avoid assuming technology access (e.g., internet, computers) or literacy based on patient demographics (e.g., age), as this creates diversity barriers and complicates trial participation.
• Eliminate the "Tick Box" Culture: The industry must move away from simply ticking boxes for training completion and compliance, focusing instead on the quality and sensible application of training and procedures to ensure actual preparedness and quality outcomes.
• Clinical Trials Must Be Embedded in Routine Care: To increase patient access and physician participation, clinical research needs to be simplified and integrated into the standard healthcare system, rather than remaining a specialized, separate activity.
• Acknowledge Site as the Hub: Sponsors and CROs must recognize that the site is the central "Lynch pin" and the hub of all information exchange (sponsor to site, site to patient, data return), requiring robust support and communication infrastructure.

Tools/Resources Mentioned:

• Veeva ID: A Veeva product announced at the summit, designed to improve the site experience for logging into various systems.
• Veeva Study Portal: A Veeva product announced at the summit, aimed at streamlining site operations.
• EDC (Electronic Data Capture): Mentioned as a historical technological shift 20 years ago that failed to account for increased site workload.
• eDiaries: Electronic patient diaries used in trials.
• IVRS (Interactive Voice Response System): Mentioned as a historical technology used for randomization.

Key Concepts:

• Patient Centricity: The concept of designing trials and technology around the needs and experiences of the patient, which the speakers argue is currently lacking in technology implementation.
• Site Solutions: A strategy area within Veeva focused on improving the tools and processes used by clinical trial sites.
• GxP / 21 CFR Part 11 (Implied): The regulatory environment is referenced through the discussion of protocol rigidity, deviations, and the need for audit trails and transparency in issue logging.