A New Role for Real-World Data in Clinical Trials: Patient Authorized Workflows

Collecting patient-level data is essential for clinical trials, with privacy and security being paramount. De-identified linking of real-world data (RWD) to trial data enhances evidence generation, but sometimes identifiable RWD is needed for daily trial operations. With the right authorizations and consents, token generation can link identifiable RWD while minimizing PII movement. Datavant’s ecosystem helps Sponsors find fit-for-purpose data partners for their specific trial needs.

‍Key Insights Include:

• Understanding Patient Consent: Importance of obtaining and managing patient consent for data linkage.
• Integrating Clinical and Real-World Data: Enhancing research with comprehensive data integration.
• Privacy and Compliance: Ensuring compliance with HIPAA regulations.
• Practical Implementation: Step-by-step guidance on implementing workflows.
• Use Cases: Applications such as patient recruitment through advocacy groups and long-term follow-up via RWD.
• Future Perspectives: Evolving landscape of clinical trial data management.

This eBook is an essential guide for life sciences professionals looking to leverage patient-authorized data to advance their research and development efforts.