Unblinded: A Clinical Trial Podcast Clinical Data Innovation In A Non-EDC Centric World
Nov 1, 2023
Patrick Nadolny, Global Head of Clinical Data Management at Sanofi, discusses the future of EDC, new programs at Sanofi, and the need for a patient-driven trial model. They explore the evolving landscape of clinical data management, the impact and challenges of data management in clinical trials, and the importance of simplifying processes and partnering with technology providers for solutions. They also emphasize the need for continued experimentation and rethinking strategies in clinical data innovation.
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Data Management Needs A Bigger Role
- Clinical data management must transform beyond EDC to handle high-volume, high-variety sources like imaging and genomics.
- Teams must shift from simple capture and checks to extracting value and operationalizing complex protocols.
Regulators Are Pushing Modernization
- Regulators are ahead and pushing modern approaches like risk-based focus on critical data and processes.
- The industry must simplify data collection and design protocols that are operationally feasible, not just scientifically sound.
Ask Patients And Offer Choice
- Ask patients what they want and offer choices within protocol constraints instead of assuming preferences.
- Integrate multiple data modalities so patients and investigators can access a single view of trial data.