Episode 5: How Will RTSM Impact Clinical Data?

This video provides an in-depth exploration of the evolution and future impact of Randomization and Trial Supply Management (RTSM) on clinical data, featuring Natalie Townsend, VP, Strategy, Veeva RTSM, and Richard Young, VP, Strategy, Veeva Vault CDMS. The discussion traces the journey of digital clinical trials from their early, often cumbersome, phone-based and spreadsheet-centric beginnings to the sophisticated, cloud-based solutions prevalent today. A central theme is the critical interplay between RTSM and Electronic Data Capture (EDC) systems, examining how data management, site supplies, and randomization can harmoniously integrate to overcome long-standing challenges in clinical trial operations.

The conversation highlights the persistent issues within the RTSM space, such as managing complexity and ensuring timely, accurate data flow, despite significant technological advancements. Townsend points out that many current processes are still influenced by past Corrective and Preventive Actions (CAPAs) from 10-15 years ago, even when modern tools could offer more efficient solutions. This leads to the concept of moving from "anxiety of change" to "confidence in success," urging the industry to re-evaluate legacy practices and embrace new technologies to anticipate future needs rather than being inhibited by past failures. The speakers emphasize the need for open architecture and intelligent, connected workflows that allow both RTSM and EDC systems to operate optimally without compromising each other's design requirements.

Furthermore, the video delves into the strategic considerations for integrating these systems, advocating for a flexible approach rather than a mandated one-way data flow. It suggests that RTSM should ideally handle only the minimal data necessary for randomization and trial supply, keeping processes lean and efficient. The dialogue also touches upon the broader tension between scientific rigor and operational excellence in trial design, likening it to solving a complex Rubik's Cube. The ultimate goal is to bridge existing silos between data managers and supply managers, fostering a unified approach that ensures technology supports, rather than hinders, scientific advancement and operational agility, especially in the face of unforeseen circumstances like a pandemic. The discussion concludes with a vision for truly digital communication workflows, enhanced compliance reporting, and the elimination of outdated practices like paper CRFs and batch edit checks in favor of real-time, intelligent monitoring.

Key Takeaways:

• Evolution of Clinical Data Management: Clinical trials have progressed from rudimentary phone-based and spreadsheet systems to sophisticated web and cloud-based solutions, significantly improving data entry and management processes.
• Persistent Challenges in RTSM: Despite technological advancements, the RTSM space still grapples with challenges related to handling complexity, ensuring data is in the right place at the right time, and seamless integration with other clinical systems.
• Re-evaluating Legacy Processes: Many current operational practices are rooted in past CAPAs or decisions made years ago, which may no longer be optimal with modern toolsets. There's a critical need to revisit and modernize these processes.
• Embracing Change with Confidence: The industry should shift from an "anxiety of change" mindset, which anticipates failure, to a "confidence in success" approach, leveraging new technologies to drive efficiency and innovation.
• Seamless RTSM-EDC Integration: The goal is to achieve better connected workflows between RTSM and EDC systems, allowing each system to maintain its optimal design without being compromised by integration requirements, moving beyond simple data auto-population.
• Open Architecture for Flexibility: Systems should be built with open architecture to support flexible, bidirectional data flow, acknowledging that the starting point for data integration (e.g., EDC to RTSM or vice versa) can vary based on protocol design.
• Minimalist RTSM Data Strategy: RTSM systems should ideally focus on handling only the minimal data required for randomization and trial supply, ensuring lean processes and reducing complexity for data managers.
• Balancing Scientific and Operational Excellence: Clinical trial design involves a delicate balance between scientific rigor and operational efficiency. Technology should enable both to move in lockstep, rather than creating tension or holding back scientific progress.
• Bridging Silos in Clinical Operations: There is a need to unify the perspectives and solutions for data managers and supply managers to prevent fragmented approaches and ensure a holistic view of trial operations.
• Agile and Adaptable Technology: To cope with rapidly changing scientific needs and unforeseen global events (e.g., pandemics), clinical trial applications must be agile and capable of quick adaptation, avoiding monolithic systems that are difficult to pivot.
• Standardization for Clarity: Establishing RTSM standards, similar to CRF libraries in EDC, and aligning on terminology (e.g., "transaction dates" vs. "event dates") is crucial to prevent confusion, reconciliation issues, and improve overall data quality.
• Truly Digital Communication Workflows: A future vision includes entirely digital and seamless communication workflows for resolving data changes, queries, and deviations, eliminating reliance on paper, emails, and manual interventions.
• Enhanced Compliance Reporting: The industry should better utilize existing data from RTSM (drug accountability), EDC (visit dates), and ePRO/devices to generate more comprehensive and insightful compliance reports, moving beyond basic data cleaning.
• Elimination of Outdated Practices: Practices like paper CRFs, scanning/signing paper forms, and batch edit checks should be relegated to the past. Modern systems should provide real-time alerting and intelligent monitoring of data discrepancies.

Tools/Resources Mentioned:

• Veeva RTSM (Randomization and Trial Supply Management)
• Veeva EDC (Electronic Data Capture)
• Veeva Vault CDMS (Clinical Data Management System)
• ePRO (Electronic Patient Reported Outcomes)
• IVR (Interactive Voice Response)

Key Concepts:

• RTSM (Randomization and Trial Supply Management): Technology used in clinical trials to manage patient randomization into study arms and the supply of investigational products.
• IRT (Interactive Response Technology): An older, broader term encompassing IVR and IWR (Interactive Web Response), often used interchangeably with RTSM in the past.
• EDC (Electronic Data Capture): Software used to collect clinical trial data from sites in an electronic format.
• ePRO (Electronic Patient Reported Outcomes): Electronic systems for patients to directly report their health status and experiences.
• CAPA (Corrective and Preventive Action): A system for identifying, documenting, and resolving non-conformances and preventing their recurrence, often impacting operational processes.
• CRF (Case Report Form): A document, electronic or paper, designed to record all protocol-required information on each trial participant.
• Open Architecture: System design that allows for easy integration and interoperability with other systems and platforms.

Examples/Case Studies:

• Adaptive Trials: Discussion of planned mid-study amendments for adaptive trials, including new cohorts, doses, and visit schedules, highlighting the need for flexible systems.
• Extensive Screening Processes: An example where a very extensive screening process with numerous calculations and data points naturally sits better within the CRF before integrating with RTSM, illustrating the need for protocol-specific data flow decisions.