Industry Perspective on Streamlining Information Sharing

This video provides an in-depth exploration of the critical need to streamline information sharing and collaboration within clinical trials, drawing insights from the 2020 Veeva Unified Clinical Operations Survey. Presented by Jason Methia, VP of Site Engagement Strategy at Veeva Systems, the discussion highlights how legacy processes for data sharing have long been a significant barrier to modernizing clinical trials, a challenge further exacerbated and accelerated by the COVID-19 pandemic. The core issue revolves around inefficient information exchange between sponsors, Contract Research Organizations (CROs), and clinical research sites, leading to increased administrative burden, higher costs, and a diversion of focus from strategic, patient-oriented activities.

The presentation details the evolution of technology adoption in clinical trials, noting the initial positive step of moving from paper to electronic systems within sponsors and CROs. However, this progress has introduced unintended consequences: the independent implementation of various systems by different functional areas often creates application and process silos, or necessitates complex internal integrations. This fragmentation has prompted an industry-wide movement towards a unified clinical trial system landscape, with 98% of survey respondents recognizing this need and 83% actively pursuing or planning such initiatives. This internal unification, while beneficial, is identified as only one piece of the puzzle, as it fails to address the crucial external digital engagement and automated information flow between sponsors, CROs, and the tens of thousands of clinical research sites where most trial activity occurs.

The video further elaborates on why external information sharing is paramount: clinical trials are growing larger and more complex, increasing reliance on CROs and sites, and generating unprecedented amounts of information that requires seamless collaboration. The current methods of interaction—predominantly email (78%), paper (40%), and investigator portals (38%)—are shown to be inefficient and costly. These methods are characterized by manual environments, extensive rework, and disconnected system landscapes at the sponsor level. Investigator portals, despite being a recent attempt to improve collaboration, have largely failed to deliver desired results because they typically don't cover all aspects of site engagement, require multiple integrations, and are not true site solutions designed to support a site's day-to-day operations. The long-term disruption of COVID-19 is expected to accelerate the adoption of more digital, automated, and connected forms of collaboration, pushing the industry towards full system interoperability not just within organizations, but across the entire ecosystem from sponsor to site and even to patient solutions.

Key Takeaways:

• Persistent Challenges in Clinical Trial Collaboration: Legacy processes for data sharing and collaboration have historically been significant barriers to modernizing clinical trials, a problem intensified by the COVID-19 pandemic which highlighted the urgent need for digital transformation.
• Impact of Fragmented Technology Adoption: While the industry has moved from paper to electronic systems, the independent adoption of various clinical trial applications by different functional areas within sponsors and CROs has created application and process silos, leading to complex internal integrations and inefficiencies.
• Industry Shift Towards Unified Systems: There is a strong industry consensus on the need for unified clinical trial systems and processes, with 98% of respondents reporting this need and 83% having or planning initiatives to consolidate clinical applications within their organizations, often moving to a platform strategy across multiple functional areas.
• Limitations of Internal Unification: While internal unification within a sponsor or CRO is a positive step, it does not fully address the critical challenge of digitally engaging, automating, and connecting information flow between sponsors/CROs and the vast network of clinical research sites.
• Drivers for Improved Information Exchange: The primary drivers for simplifying information exchange with study partners include reducing manual processes (75%), increasing visibility and oversight (58%), achieving faster study execution (58%), and improving study quality (58%).
• Inefficiency of Current Communication Methods: Email (78%), paper (40%), and investigator portals (38%) remain the predominant methods for information exchange between sponsors/CROs and sites, all of which contribute to manual environments, rework, and disconnected system landscapes.
• Shortcomings of Investigator Portals: Investigator portals, while intended to improve site collaboration, often fall short because they typically do not cover all aspects of site engagement, require multiple integrations, and are not purpose-built as true site solutions to support a site's day-to-day operations.
• Accelerated Digital Transformation Post-COVID-19: The COVID-19 pandemic is expected to positively disrupt clinical trials, accelerating the adoption of technology for more virtual and remote trials, and driving the industry towards more digital, automated, and connected forms of collaboration.
• Need for Full System Interoperability: To truly address the challenges of time and effort in clinical trial information sharing, the industry requires full system interoperability not only within sponsors and CROs but critically, across the entire ecosystem from sponsor to site and even out to patient solutions.
• Focus on High-Value Activities: The goal of streamlining information sharing is to reduce the high administrative burden and allow the workforce to shift from low-value, high-volume transactional activities to more strategic, high-value trial or patient-oriented activities.

Key Concepts:

• Unified Clinical Trial System Landscape: A strategy where clinical applications across multiple functional areas (e.g., clinical operations, data management, monitoring, startup) are consolidated under one technology platform or roof within a sponsor or CRO.
• Application/Process Silos: Disconnected systems and workflows that arise when various technologies are implemented independently by different functional areas without a comprehensive system strategy.
• Investigator Portals: Web-based platforms developed by sponsors or CROs to facilitate interaction and information exchange with clinical research sites, often criticized for not being comprehensive or site-centric.
• Decentralized Clinical Trials (DCTs): Clinical trials that incorporate virtual or remote elements, allowing some or all trial activities to occur outside traditional site settings, often leveraging technology for patient engagement and data collection.
• System Interoperability: The ability of different information systems, devices, and applications to access, exchange, integrate, and cooperatively use data in a coordinated manner, both within and across organizational boundaries.

Tools/Resources Mentioned:

• Veeva Unified Clinical Operations Survey (2020): The primary source of data and findings discussed in the video, highlighting industry trends and needs.
• Veeva Systems: The company channel and speaker's affiliation, indicating their role in providing solutions for clinical operations.