Season 2 Episode 4: Clinical Data Innovation In A Non EDC Centric World

This video provides an in-depth exploration of clinical data innovation, focusing on the strategic shift away from traditional Electronic Data Capture (EDC)-centric clinical trials toward integrated, patient-driven ecosystems. Featuring Patrick Nadolny, Global Head of Clinical Data Management at Sanofi, the discussion establishes that the pharmaceutical industry is at a critical inflection point, necessitated by the explosion of new data sources (ePRO, imaging, wearables, genomics) and the increasing complexity of trial protocols (adaptive, basket, umbrella, and platform designs). The core argument is that the current siloed technology landscape—where EDC, ePRO, telemedicine, and home nursing systems operate independently—must be unified to reduce site and patient burden and extract maximum value from the data.

Nadolny details Sanofi’s "Act for Patients" initiative, which aims to make patient-driven, decentralized trials the default model within two to three years. This initiative is centered on giving patients choice in how they participate (e.g., home nursing vs. site visits) and requires a comprehensive technological overhaul to integrate all data modalities into a single, cohesive ecosystem. The goal is to achieve "EDC-less" trials, where data is collected digitally from the outset, enabling real-time centralized monitoring and significantly reducing the need for traditional on-site Source Data Verification (SDV). This transformation necessitates moving beyond reactive data cleaning to proactive, predictive data management, fundamentally changing the role of Clinical Data Management (CDM) to Clinical Data Science.

A significant portion of the discussion focuses on regulatory drivers. Nadolny asserts that regulators, particularly the FDA and EMA (via ICH E6 R2 and ICH E8), are often ahead of the industry, pushing for risk-based approaches that prioritize critical data and operational feasibility through Quality by Design (QbD). Furthermore, the European Union's proposed European Health Data Space is highlighted as a potential game-changer. This initiative aims to harmonize electronic medical records across Europe, creating a vast wealth of real-world data that could be leveraged for synthetic control arms and safety monitoring. This shift implies a future where regulators may possess more comprehensive safety data on a product than the sponsor itself, drastically altering the dynamics of safety management and submission. The speakers also emphasize the need for the industry to embrace the "5 Vs" of data—Volume, Variety, Velocity, Veracity, and Value—with a particular focus on Veracity (ensuring end-to-end data lineage and traceability) and Value (ensuring data collected is meaningful and actionable).

Key Takeaways:

• The End of Traditional EDC: The term "EDC" is becoming obsolete as trials move toward integrated, multi-modal data capture environments. The industry must retire the term to avoid anchoring thinking to past, siloed processes and embrace "EDC-less" or patient-driven ecosystems.
• Proactive, Predictive Data Management: Clinical Data Management must evolve into Clinical Data Science, shifting focus from reactive data cleaning (simple edit checks) to proactive, predictive algorithms that anticipate missing data or anomalies before they occur, ensuring data quality by design.
• Regulatory Compliance as a Driver: Modern regulations (ICH E6 R2, ICH E8) mandate a risk-based approach, requiring sponsors to focus resources on critical data and processes. This is not about taking risks but reducing them by focusing on what truly matters for patient safety and trial reliability.
• Need for Technology Integration: The biggest technological challenge is integrating currently siloed systems (EDC, ePRO, telemedicine, home nursing, wearables, imaging) into one unified ecosystem to provide investigators and patients with a single view of all clinical data.
• Patient Choice is Paramount: True patient-centricity requires offering patients choices in how they participate (e.g., site visit, home nurse, telemed) based on their health status and personal preferences, rather than forcing a single technology solution.
• Impact of European Health Data Space (EHDS): This upcoming EU regulation will harmonize electronic medical records, creating a massive pool of real-world data. Sponsors must prepare for a future where this data can be used for synthetic control arms and where regulators may have superior safety data access.
• Avoidable vs. Unavoidable Complexity: The industry must eliminate "avoidable complexity" (e.g., thousands of edit checks that never fire) to focus resources on "unavoidable complexity," such as managing adaptive trial designs that require instantaneous protocol and technology changes.
• Data Veracity and Lineage: With diverse data sources, ensuring the veracity (truthfulness and traceability) and end-to-end lineage of data from its point of inception to consumption is a complex but critical requirement for regulatory compliance.
• Shift in Monitoring Strategy: The reliance on on-site monitoring will dramatically decrease due to the adoption of digital processes (eConsent, eSource, direct drug shipment), leading to a massive increase in centralized, remote data review and monitoring activities.
• SDM's Role in Workforce Transformation: Industry bodies like the Society for Clinical Data Management (SCDM) are crucial for defining the "new CDM norm" and developing new training and certification programs to equip data managers with the skills needed for complex data flows, AI concepts, and regulatory modernization.

Tools/Resources Mentioned:

• Veeva Systems (Podcast host/context)
• EDC (Electronic Data Capture)
• ePRO (Electronic Patient Reported Outcomes)
• ICH E6 R2 and ICH E8 (Regulatory guidelines)
• European Health Data Space (Upcoming EU regulation)

Key Concepts:

• EDC-less Trials: A concept where clinical trials move away from reliance on a traditional EDC system as the primary data capture tool, instead integrating data from multiple digital sources (eSource, ePRO, wearables) into a centralized data hub.
• Risk-Based Approach (RBA): A regulatory methodology (mandated by ICH E6 R2) that requires sponsors to focus monitoring and data quality efforts on critical data and processes essential for patient safety and trial reliability, rather than verifying every data point.
• Veracity (of Data): One of the "5 Vs" of data, referring to the quality, accuracy, and trustworthiness of the data, including ensuring its complete lineage and traceability from source to analysis.
• Act for Patients: Sanofi’s initiative focused on simplifying the lives of sites and patients by enabling patient choice in participation modalities and integrating all data streams to reduce burden.

Examples/Case Studies:

• Sanofi's Act for Patients: A strategic initiative aiming to make patient-driven, EDC-less trials the default model by 2025/2026, focusing on integrating siloed technology systems to support flexible patient participation (telemedicine, home nursing).
• War in Ukraine Scenario: Used as an example of the failure of current medical record systems; patients displaced from Ukraine required full medical re-screening in neighboring countries, costing billions. The European Health Data Space aims to solve this by harmonizing electronic medical records across the EU.
• Edit Check Inefficiency: An observation that in many studies, up to half of the programmed edit checks never fire, highlighting the industry's tendency toward "avoidable complexity" and the need to replace simple checks with predictive algorithms.