Season 4 Episode 3: Innovation from the Inside: How Sites Are Redefining Clinical Research

This video provides an in-depth exploration of innovation in clinical research, focusing on how research sites are redefining their operations through technology and collaboration. Hosted by Manny Vasquez from Veeva, the discussion features Denali Rose (Veeva, Site Solution Strategy) and Joe Lengfellner (Memorial Sloan Kettering Cancer Center - MSKCC, Clinical Research Informatics and Innovation Consortium Lead). The conversation delves into the daily challenges faced by clinical trial coordinators, the inefficiencies of current data management practices, and the transformative potential of advanced technologies like EHR-to-EDC integration and Large Language Models (LLMs) in areas such as patient recruitment and health equity.

The discussion begins by highlighting the often-underappreciated and chaotic role of clinical research coordinators, who juggle patient management, data curation, regulatory tasks, and financial coordination. Joe Lengfellner from MSKCC describes how coordinators spend a significant portion of their time on data management, often manually transferring information from electronic health records (EHRs) to electronic data capture (EDC) systems. This manual process is identified as a major bottleneck, leading to inefficiencies, potential errors, and high turnover rates among coordinators. The speakers emphasize the need for technological solutions to alleviate this burden, particularly through direct data capture and integration.

A significant portion of the conversation focuses on the shift towards sites taking ownership of their technological infrastructure. MSKCC's initiative to implement EHR-to-EDC integration using FHIR resources and APIs with a vendor like Ignite Data is presented as a prime example of a large academic center digitizing its workflows to improve scalability and data accuracy. For smaller sites, the focus shifts to eSource solutions and the challenge of duplicate data entry between eSource systems and sponsor-provided EDCs. The speakers advocate for a "Bring Your Own Technology" (BYOT) approach, where sponsors support sites in using their preferred and established tools, rather than imposing new, disruptive systems for each trial. The podcast also explores the evolving relationship between sites, sponsors, and CROs, noting a positive trend towards more open dialogue and genuine site-centricity, moving beyond mere buzzwords.

Finally, the discussion ventures into cutting-edge innovations, particularly the application of LLMs and AI in clinical research. Joe Lengfellner introduces MSKCC's Clinical Research Innovation Consortium (CRIC), a collaborative initiative involving sites, sponsors, technology providers, and regulators to identify and test industry-wide solutions. A key project within CRIC involves evaluating LLMs for clinical trial matching and patient recruitment. An example is shared where an LLM successfully identified all patients manually matched by coordinators, plus additional eligible patients who were previously missed, demonstrating the technology's potential to enhance patient access, improve diversity in trials, and address health equity challenges. The speakers conclude with a call to action for the industry to embrace risk-taking in technology adoption and foster greater inter-stakeholder communication and collaboration.

Key Takeaways:

• Undervalued Role of Clinical Trial Coordinators: Clinical research coordinators perform a wide array of tasks, from patient recruitment and management to regulatory and financial duties, often in chaotic environments, making it one of the most challenging and underappreciated roles in the industry.
• Data Curation as a Major Bottleneck: A significant portion of a coordinator's day, sometimes up to 100% for specialized roles, is spent on manual data curation, involving copying and pasting data from clinical records (EHRs) into EDC systems and responding to queries.
• Critical Need for EHR-to-EDC Integration: Direct integration between EHRs and EDCs is essential for improving the efficiency, scalability, and data quality of clinical trials, reducing manual effort, and enabling more trials to be conducted.
• Challenges with Protocol Amendments: Managing protocol amendments is highly complex and duplicative, requiring multiple teams to update different representations of the trial across various systems (EDC, CTMS, EHR treatment plans, eConsent), leading to delays and potential errors.
• Site-Driven Technology Adoption (Esource & BYOT): Research sites are increasingly adopting their own electronic source (eSource) and eConsent tools, and there's a growing need for sponsors to support a "Bring Your Own Technology" (BYOT) approach to avoid disrupting established site workflows.
• Duplication in Digital Workflows: Even with eSource, sites often face the challenge of entering the same data twice – once into their eSource system and again into the sponsor's EDC, highlighting the need for direct data capture or unified systems.
• Evolving Site-Sponsor Relationship: There's a positive shift towards genuine site-centricity, with sponsors showing more willingness to listen to sites' challenges and collaborate on solutions, moving beyond superficial engagement.
• LLMs for Patient Recruitment and Health Equity: Large Language Models (LLMs) and AI hold immense potential for revolutionizing clinical trial matching, patient identification, and recruitment, helping to find previously missed eligible patients and improve diversity and health equity in trials.
• Clinical Research Innovation Consortium (CRIC): Collaborative initiatives like MSKCC's CRIC, which brings together sites, sponsors, tech providers, and regulators, are crucial for vetting and scaling innovative technologies in a metrics-driven manner.
• Data Access for AI Solutions: A significant hurdle for effective AI-powered patient recruitment is gaining access to comprehensive patient data, especially for the large population of patients outside of major academic centers (e.g., 80% of oncology patients in the community).
• Risk Aversion Hinders Innovation: The industry's risk-averse culture, particularly among sponsors, often leads to prolonged pilot programs for new technologies, causing promising solutions to "die on the vine" instead of being widely adopted.
• Standardization of Site Workflows: Sites benefit greatly from standardizing their internal workflows and technology across their portfolio of studies; disparate sponsor-mandated systems (e.g., multiple e-consent platforms) can be highly disruptive and lead to a reversion to paper-based processes.
• Call for Inter-Stakeholder Communication: There is a strong call for increased and more open dialogue between different stakeholders—sites, sponsors, and CROs—to understand each other's challenges and collaboratively drive industry improvement.

Tools/Resources Mentioned:

• Veeva (Clinical Data Strategy, Site Solution Strategy)
• Ignite Data (Vendor for EHR-to-EDC integration)
• FHIR resources/APIs (Technical standard for data exchange in EHRs)
• Epic (EHR system mentioned for treatment plans)
• EDC (Electronic Data Capture systems)
• EHR (Electronic Health Records)
• eSource (Electronic Source documentation systems)
• CTMS (Clinical Trial Management Systems)
• eConsent (Electronic Consent platforms)
• Large Language Models (LLMs)
• AI (Artificial Intelligence)

Key Concepts:

• Site Centricity: A philosophy and approach in clinical trials that prioritizes the needs and workflows of research sites, aiming to make their participation more efficient and less burdensome.
• EHR-to-EDC Integration: The automated transfer of clinical data from a hospital's Electronic Health Record system directly into a sponsor's Electronic Data Capture system, reducing manual data entry.
• Esource: Electronic capture of source data directly at the point of care or data generation, eliminating the need for paper source documents.
• Direct Data Capture: A method of collecting clinical trial data directly into an electronic system, bypassing paper records and often integrating with other systems.
• Clinical Research Innovation Consortium (CRIC): A collaborative group (started at MSKCC) focused on identifying, evaluating, and implementing innovative technologies to solve industry-wide problems in clinical research.
• Health Equity / Patient Diversity: Efforts to ensure that clinical trials are accessible to and representative of diverse patient populations, addressing disparities in healthcare access and outcomes.
• BYOT (Bring Your Own Technology): A concept where research sites are allowed or encouraged to use their existing, preferred, and integrated technologies for clinical trial activities, rather than being forced to adopt sponsor-specific tools.

Examples/Case Studies:

• Memorial Sloan Kettering's EHR-to-EDC Initiative: MSKCC is actively working with Ignite Data to leverage FHIR resources and APIs to pull clinical data directly from their EHR (Epic) into EDC systems, aiming to eliminate manual data entry for coordinators.
• CRIC's LLM-based Patient Recruitment Project: The Clinical Research Innovation Consortium conducted a metrics-driven evaluation of LLMs for clinical trial matching. By providing a vendor with a month's worth of patient data and three trials, the LLM not only identified all patients manually matched by coordinators but also found additional eligible patients who had been previously missed, demonstrating its potential to expand patient access to trials.