Vertex Reduces EDC Study Build Times by 50%

This video provides an in-depth exploration of how Vertex Pharmaceuticals significantly reduced its EDC (Electronic Data Capture) study build times and accelerated clinical data lock processes, achieving a 50% reduction in study build times. Featuring insights from Vertex's senior and associate directors of clinical data management and metrics, Vitas Galati and Michelle Garrison, alongside Richard Young from Veeva Systems, the discussion highlights Vertex's journey in optimizing clinical operations. The webinar contrasts Vertex's industry-leading performance against broader industry benchmarks, particularly referencing "Tufts data" on average timelines for data entry, query resolution, and database lock.

The core of Vertex's success lies in a multi-faceted approach centered on a "sites first, patients first" philosophy. This ethos drives their operational strategies, emphasizing consistency in database creation, standardized query application, and continuous, open communication with clinical sites. Vertex actively engages sites through regular meetings, data management-specific tables at investigator meetings for live demos and feedback, and weekly newsletters for updates and training. This collaborative approach, coupled with a focus on understanding site motivations rather than imposing penalties, has led to exceptional site performance, with data entry often within 48 hours and query responses within 72 hours, significantly outperforming industry averages.

A key conceptual shift discussed is the move from "database lock" to "data lock," recognizing that 70-80% of critical study data often originates from external sources outside the EDC system. Vertex prioritizes the reconciliation and locking of all relevant data, including external data, aiming for a complete, quality-assured data lock within 15 days from the last subject's last visit. This aggressive timeline is supported by proactive data review starting from the first patient screen, ensuring live data access for clinical and medical monitoring teams, and automating lab data downloads within 24 hours. The "onion slide" concept illustrates Vertex's layered, risk-based approach to data review, acknowledging that multiple checks occur at various stages, allowing for more focused attention on critical data points. The entire process requires strong organizational buy-in across clinical, medical, and vendor teams, with a culture of continuous innovation and improvement.

Key Takeaways:

• Industry-Leading Performance: Vertex achieved a 50% reduction in EDC study build times and consistently locks clinical data within 15 days, significantly faster than the industry average of 40 days. They also boast rapid data entry (within 48 hours) and query response (within 72 hours) from sites.
• Site-Centric Philosophy: A "sites first, patients first" approach is paramount. Vertex fosters collaboration and understanding with sites, using a "carrot, not stick" method, avoiding penalty clauses, and focusing on consistent processes and clear communication to motivate high-quality data submission.
• Proactive Data Management: Data review begins immediately from the first patient screen, not waiting for milestones. This ensures continuous monitoring and early identification of issues, allowing clinical and medical monitoring teams live access to data for real-time patient oversight.
• Emphasis on External Data: Recognizing that 70-80% of primary and secondary endpoint data often comes from external sources (e.g., labs), Vertex redefines "database lock" to "data lock," focusing on comprehensive reconciliation and locking of all critical data, internal and external.
• Automated Data Acquisition: Significant effort is invested in automating data downloads from primary labs, aiming to receive lab data within 24 hours of collection or report generation, drastically reducing data transfer times.
• Risk-Based Data Review: The "onion slide" concept illustrates that data undergoes multiple layers of review (e.g., CCGs, error checks, CDM, cross-functional teams). This allows for a risk-based approach, dedicating more intensive review to critical data points while trusting the multi-layered system for general data quality.
• Organizational Buy-in is Crucial: Achieving rapid data lock requires a coordinated effort and buy-in from the entire organization, including clinical, medical, and vendor teams, ensuring everyone is aligned with the quality and timeline goals.
• Strategic Vendor Management: Vertex engages vendors early in the contracting process to establish expectations for timely and quality data transfers. They also explore consolidating vendors or routing specialty lab data through central labs to streamline data flow and reduce the number of interfaces.
• Continuous Improvement and Standardization: Lessons learned from every study are applied to subsequent trials. Vertex emphasizes training, standardizing data transfer specifications, and reusing data collection standards to achieve greater efficiency and consistency.
• Innovation as a Cultural Imperative: Vertex maintains a culture of innovation, constantly challenging internal processes and seeking better, faster ways to operate while maintaining quality, which was a key driver in their partnership with Veeva.

Tools/Resources Mentioned:

• Veeva Systems: The platform and software used by Vertex for their clinical data management, specifically EDC.
• Tufts Data: Research on industry benchmarks for clinical trial timelines (data entry, query resolution, database lock).

Key Concepts:

• EDC Study Build Times: The time required to set up and configure an Electronic Data Capture system for a new clinical study.
• Data Lock / Database Lock: The process of finalizing and freezing a clinical trial database or all relevant study data (including external sources) to prevent further changes before analysis and submission. Vertex advocates for "data lock" to encompass all critical data, not just what's in the EDC.
• Clinical Data Management (CDM): The process of collecting, cleaning, and managing data from clinical trials to ensure its accuracy, completeness, and validity.
• Site-Centric Approach: A philosophy in clinical trials that prioritizes the needs and experiences of the clinical research sites and their staff to foster better collaboration and data quality.
• Risk-Based Data Review: A strategy for reviewing clinical trial data where resources and effort are concentrated on data points and processes deemed most critical to patient safety and study integrity, rather than uniformly reviewing all data.

Examples/Case Studies:

• Vertex Pharmaceuticals: The entire discussion serves as a case study of Vertex's successful implementation of advanced clinical data management strategies, showcasing their specific achievements in reducing study build times and accelerating data lock processes in their cystic fibrosis (CF) trials.