Season 3 Episode 5: Is a Heavy Tech Burden the Price of Progress for Sites?

This podcast episode, recorded at the Veeva R&D Summit, features a handover of the host role from Richard Young to Manny Vazquez (Veeva Strategy Director and former data manager), followed by an in-depth conversation with Brad Hightower, owner of the clinical research center Hightower Clinical. The discussion centers on the technological and operational realities faced by clinical research sites as the industry pushes toward digital and decentralized clinical trials (DCTs). The core question explored is whether the growing "heavy tech burden" is an inevitable price of progress and how sponsors can better support sites.

The conversation begins by establishing the persistent challenges sites face in moving away from paper. Hightower notes that while his site is committed to going fully electronic, paper remains necessary for certain contexts, such as device trials in operating rooms or managing incoming regulatory documents and medical records (often received via fax). A major inefficiency highlighted is the double data entry inherent in the traditional process: sites create their own Source Documents, then manually transcribe that data into the sponsor's Electronic Data Capture (EDC) system. Hightower points out that clear FDA guidance allows for direct data entry into EDC, and he remains perplexed as to why the industry continues to mandate the redundant step of separate source documentation.

Regarding the shift to DCTs, the site perspective is one of cautious skepticism toward the recent FDA draft guidance. While Hightower supports the goal of increasing patient access and involvement, he notes that the guidance places significant management burden on sites, particularly when utilizing external healthcare providers (HCPs) for study visits. He argues that managing these external HCPs is essentially the same amount of work as managing another satellite site, a cost he doubts will be adequately reflected in study budgets. Furthermore, he stresses that many sites already possess the capability (e.g., telehealth platforms, mobile coordinators) to execute decentralized elements, but sponsors often mandate the use of third-party vendors, undermining the PI’s ability to maintain direct oversight of staff conducting assessments.

The speakers also address the perceived "tech burden." Hightower rates the technology burden (managing multiple logins, disparate systems) lower than fundamental issues like poor budgeting, overly restrictive inclusion/exclusion criteria, and patient retention. He argues that the true burden is often poor implementation and bad study design, such as overly complex query programming within EDC systems, rather than the inherent quality of the technology itself. This lack of a clear feedback loop between sites and sponsor data management teams means sites often endure inefficiencies without recourse. The increasing volume of data from disparate sources (e.g., wearables, eCOA, central labs) further complicates matters, making it difficult for Principal Investigators (PIs) to maintain adequate oversight and sign-off on the complete and concurrent patient record. This complexity is driving a transformation in site roles, necessitating the hiring of tech-savvy staff and specialists, such as "eSource Architects," to manage the technical builds required for each study.

Key Takeaways:

• Double Data Entry is an Avoidable Burden: Despite FDA guidance encouraging direct data entry into EDC, the industry standard still forces sites to create separate source documents and then transcribe the data, leading to significant inefficiency and duplicated effort.
• Sponsor Guidelines for eCRFs are Often Insufficient: Sites rely heavily on eCRF guidelines and protocols to build their source documents, but these guidelines are frequently unclear (e.g., stating "vitals" without specifying the number of sets or positions required), leading to confusion and rework.
• Decentralization Requires Site Empowerment: Sites often already have the capabilities (e.g., telehealth, mobile coordinators) to execute decentralized elements, but sponsors must explicitly allow these methods in the protocol rather than mandating external, unfamiliar third-party vendors.
• DCT Guidance Increases Site Management Workload: The utilization of external HCPs for study visits, as outlined in the FDA draft guidance on DCTs, creates a significant management burden for the site, requiring them to treat these external providers almost as if they were additional study staff.
• The Problem is Implementation, Not Just Technology: The primary source of the "tech burden" is often poor study design, bad database builds, and overly aggressive query programming, rather than the inherent quality of the technology tools themselves.
• PI Oversight is Challenged by Data Disaggregation: The increasing number of disparate data sources (EDC, eCOA, central labs, wearables) makes it extremely difficult for PIs to aggregate and review the complete patient record efficiently, potentially compromising oversight.
• Need for Direct Sponsor-Site Dialogue: There is a critical lack of a clear feedback loop between sites and sponsor data management/design teams. Sites need a direct channel to report implementation issues and poor study design elements, as CRAs typically lack the authority to address these technical problems.
• Role Transformation at Sites: The complexity of digital trials is driving the need for new, specialized roles at sites, such as "eSource Architects" or staff dedicated solely to managing the technical aspects of the study (e.g., managing multiple tablets, ECGs, and eCOA devices).
• Prioritize Budgeting and Patient Access Over Tech Fixes: While technology is a pain point, sites often rank budgeting/payment issues and overly narrow inclusion/exclusion criteria (which restrict enrollment of representative populations) as significantly greater burdens than the technical complexity of the tools.
• Eliminate Email for Study Communication: The use of email and shared spreadsheets for critical communications, such as budget negotiations or regulatory document exchange, is highly inefficient and prone to error; a secure, trackable portal or platform should be mandated for these activities.

Key Concepts:

• eSource (Electronic Source Documentation): Digital records created by the site to capture patient data directly during a visit, often duplicating data that is later entered into the sponsor's EDC.
• DCT (Decentralized Clinical Trials): Trials incorporating remote elements, such as telehealth visits, home health services, or wearable devices, to reduce patient burden.
• Site Centricity: The concept that optimizing the clinical trial process for the research site staff (e.g., reducing administrative burden, improving technology usability) is essential for achieving patient centricity and successful trial execution.

Examples/Case Studies:

• Device Trials in ORs: Cited as an example where paper documentation remains necessary due to environmental constraints (e.g., avoiding glass tablets, power loss concerns) and the specific nature of the data collection.
• Rural Clinic Visits: Hightower mentions the desire to send coordinators to rural clinics 40 miles away to draw blood, noting that allowing this flexibility (which the site can manage internally) improves patient compliance and enrollment rates.