Season 2 Episode 1: Does Patient Choice Equal Site Headaches?

This podcast episode, featuring Helen Shaw, Co-founder of VCTC (a virtual clinical trial site), and Marie-Claire Flavin, Director of Site Success for Veeva Site Solution, provides an in-depth discussion on optimizing clinical trial operations to enhance patient choice without sacrificing site efficiency. The central theme revolves around moving beyond traditional trial models to embrace patient-centricity and digital solutions, particularly focusing on the administrative and regulatory burdens faced by research sites. The speakers share their experiences from the operational front lines, advocating for smarter, quicker, and more inclusive trial execution.

Helen Shaw, whose background includes global trial management and a PhD in clinical trial methodology, established VCTC with the motivation to improve the historically slow pace of trial setup and recruitment, and to reduce the burden placed on patients. VCTC specializes in running patient-centric trials, ranging from traditional on-site studies to fully virtual models. Their approach is not to force a protocol into one mold, but to analyze what is required and determine the best operational path—whether that involves home visits, pop-up clinics, or traditional site visits—always prioritizing patient needs. This patient-first philosophy extends to their methodology, where VCTC actively incorporates the patient voice, including conducting User Acceptance Testing (UAT) on study apps with patients to ensure usability and confidence before rollout.

Marie-Claire Flavin, drawing on her experience as a clinical trial radiographer in the NHS, highlights how technology, specifically Veeva SiteVault, can transform site operations. She shares a compelling example of how digitizing the setup and approval process—which traditionally involves physically visiting every hospital department for signatures—reduced the setup time by four weeks. This acceleration is critical, as four weeks can mean the difference between a patient receiving a potentially life-saving treatment or progressing too far in their disease. Flavin emphasizes that technology should simplify, not complicate, the site's workflow, noting the common pitfall of sponsors providing numerous, disparate devices (e.g., 15 different tablets) that create administrative and security headaches for site staff.

The conversation culminates in a shared critique of the industry’s current terminology and documentation practices. Both speakers express a strong aversion to the phrase "decentralized clinical trials" (DCT), arguing that it implies a black-and-white approach. Helen Shaw prefers the term "centralized research," where VCTC acts as a central hub, managing processes like data entry, patient outreach, and technology training, while the physical patient visits are distributed (a hub-and-spoke model). This model, which VCTC has received approval to implement as the UK’s first Central PI model using commercial hubs and NHS clinics, allows sites to focus on the complex studies that require traditional settings. Finally, the speakers use a "magic wand" thought experiment to identify two major industry pain points: the need to eliminate the wasteful duplication of effort involved in Source Documentation (writing data down, then transcribing it to the EDC, then having a monitor check both) and the necessity of gaining electronic access to patient GP notes in the UK for research purposes, which is currently restricted and significantly lengthens recruitment time.

Detailed Key Takeaways

• Patient-Centricity Requires Operational Flexibility: Clinical trials should not be forced into a single model (traditional or virtual). Sites must assess each protocol to determine the optimal operational path, which may include hybrid models, home visits, or specialized on-site care, ensuring the delivery method meets the patient's needs and the drug's safety requirements.
• The Patient Voice is Non-Negotiable: Incorporating patient feedback, even in non-paid capacities, is vital for successful trial design and technology implementation. VCTC uses patients for User Acceptance Testing (UAT) on study apps to confirm usability and prevent technology from becoming a barrier, especially for older or less dexterous patients.
• Technology Must Reduce Administrative Burden: Digital solutions should integrate seamlessly into existing site workflows without requiring massive infrastructure changes (e.g., new computers, multiple devices). The goal is to allow staff to work "smarter and quicker," freeing up time for patient care rather than administrative tasks.
• Veeva SiteVault Streamlines Site Setup: A specific case study demonstrated that using Veeva SiteVault to digitize the internal approval process for protocols and clinical pathways within a hospital setting reduced the overall setup time by four weeks, significantly accelerating the time to first patient recruitment.
• The "Trial is Just a Trial" Philosophy: The industry should abandon the restrictive terminology of "decentralized clinical trials" (DCT) and focus on designing the most efficient and inclusive operational strategy for each unique protocol. The operational design should be driven by the protocol, not by buzzwords.
• Centralized Research as an Alternative Model: VCTC promotes "centralizing research" by using a central hub to manage administrative processes (data entry, training, outreach, IP dispensing via courier/nurse), while distributing patient visits to locations that best suit them (home, local clinic, etc.).
• Eliminate Source Documentation Duplication (Major Pain Point): The requirement to write data down (on paper or electronically) and then transcribe it field-for-field into the EDC, followed by monitoring checks, is viewed as a massive waste of time and a primary target for operational removal or automation.
• Need for Electronic Health Record (EHR) Access for Research: A critical regulatory hurdle in the UK is the inability for research teams to electronically access GP notes for patient screening and eligibility, forcing sites to rely on time-consuming manual requests that delay recruitment and burden primary care physicians.
• Patient Motivation is Access and Care: While altruism exists, patients primarily participate in trials for access to novel treatments, better care, and additional support (e.g., more frequent calls, dedicated teams, extra scans/tests) that they would not receive in standard care.
• Technology Can Hinder Relationships: If technology is poorly implemented (e.g., complex, non-intuitive devices, or systems that require excessive training), it can become a barrier, alienating patients and negatively impacting the caregiver relationship.

Tools/Resources Mentioned

• Veeva SiteVault: Used for site success, managing administrative tasks, and streamlining site setup approvals.
• EDC (Electronic Data Capture): Mentioned as the system where transcribed data is entered.
• ePRO (Electronic Patient-Reported Outcomes): Implied in the discussion of patient questionnaires and study apps.
• Telemedicine/Phone Calls: Used for remote informed consent and follow-up visits.

Key Concepts

• Patient-Centric Trials: Designing and executing clinical trials with the patient experience and needs as the primary consideration, often leading to hybrid or virtual components.
• Central PI Model (Hub-and-Spoke): A novel regulatory approach in the UK where a commercial site (VCTC) acts as the central Principal Investigator (PI) hub, coordinating research activities across multiple affiliated NHS clinics (spokes) to expand reach while maintaining centralized oversight.
• Source Documentation: The original record of clinical findings, observations, or activities related to a trial. The current requirement for sites to duplicate this information into the EDC is highlighted as a major inefficiency.

Examples/Case Studies

• COVID-Era Decentralized Trial: VCTC’s founding was based on a proof-of-concept decentralized trial run during the pandemic when hospital access was restricted, demonstrating that rapid recruitment and patient retention were possible through alternative operational models.
• Parkinson’s Disease Study Design: VCTC designed an on-site Parkinson’s trial (chosen due to complexity) to be a positive "day out" experience for patients, focusing on a nice location and social interaction (tea and biscuits) to enhance the patient experience and motivation.