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Session 7: Utilization of Real-World Data (RWD) and Real-World Evidence (RWE) in Clinical Trials
Session Chair(s)
Terry Katz, MS
Senior Director, Biostatistics and DM Planning and Functional Excellence
Daiichi Sankyo, United States
Inclusion of Real-World Data (RWD) into innovative clinical trial designs and leveraging emerging technology can enhance decentralized and adaptive trials. Electronic Medical Records (EMR) could potentially serve as a platform for identifying and qualifying patients. EMR could also potentially serve as a control for the individual participant to detect if accruing data reflects a change from historical mean vital signs and blood parameters. Real-time data loads from EMR to Electronic Data Capture (EDC) could trigger edit checks while the clinician is still with the patient and could support real-time inclusion of that participant into the adaptive phase of the trial. Wearables data could be back populated to the EMR providing clinician and Participant with the full set of accruing RWD. Limitations on interoperability and patient privacy (e.g. GDPR) would need to be addressed.
Learning Objective : - Determine the types of RWE and RWD which could augment-by-design decentralized or adaptive clinical trial designs during study start and execution
- Connect sources of patient data or community data to EDC or CDR for on-study deployment
- Evaluate data security and privacy, and identify barriers to uploading RWD back to patient’s EMR or accessible dashboards to enhance routine patient care and engage patients in clinical trials
Speaker(s)
RWD for Real-World Needs
Douglas Drake, MBA
Centogene, Switzerland
Senior Director
Leveraging Real World Data to Provide Deeper Insight to Treatment Effects in Clinical Trials
Sherrine Eid, MPH
SAS Institute Inc., United States
Global Head, RWE, Epidemiology and Observational Research
Leveraging Real World Data to Estimate Proper Target Ranges for Race and Ethnicity Representation in Conventional and Innovative Clinical Trial Design
Eric Gemmen, MA
IQVIA, United States
Senior Director, Global Epidemiology, Real World Evidence
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