Real-World Data and Real-World Evidence in Regulatory Decisions

Real-World Data and Real-World Evidence in Regulatory Decisions

Description

Dr. Jacqueline Corrigan-Curay of the US Food and Drug Administration discusses recent trends in incorporating real-world data and real-world evidence in regulatory decisions.

Speaker

Jaqueline Corrigan-Curay, JD, MD
Principal Deputy Center Director in FDA’s Center for Drug Evaluation and Research (CDER)

 

Related

View the full Grand Rounds video: Real World Evidence: Contemporary Experience and Future Directions

EHR-Based Outcome Measurement in the LIRE Trial

EHR-Based Outcome Measurement in the LIRE Trial

Description

In this video, Dr. Jerry Jarvik, PI of the LIRE trial, summarizes the challenges his team faced when embedding a radiology reporting intervention into the electronic health record.

Biography

Jerry Jarvik, MD, MPH
Radiologist, University of Washington Medical Center
Professor of Radiology, Neuroradiology, Health Services and Neurological Surgery, University of Washington
Adjunct Professor of Orthopedics & Sports Medicine and Pharmacy
LIRE NIH Collaboratory Trial PI

Related

Implementing and Monitoring the Delivery of an Intervention

View the full Grand Rounds video: Experiences From the Collaboratory PCTs

View the complete collection of EHR Workshop video modules.

Using Clinical Data to Advance Discovery

Using Clinical Data to Advance Discovery

Description

In this video, Dr. Josh Denny of the NIH's All of Us Research Program describes how researchers are building powerful algorithms for use across electronic health records systems to advance clinical research.

Biography

Josh Denny, MD, MS
CEO of NIH’s All of Us Research Program

 

 

Related

Interoperability

View the full Grand Rounds video: Real World Evidence: Contemporary Experience and Future Directions

View the complete collection of EHR Workshop video modules.

Headshot of Rachel Richesson

Uses of EHRs in NIH Collaboratory Projects

Uses of EHRs in NIH Collaboratory Projects

Description

In the NIH Pragmatic Trials Collaboratory ePCTs, the electronic health record has been used to determine eligibility, deliver the intervention, and assess outcomes. This video explores challenges and lessons learned encountered by the ICD-Pieces Trial.

Speaker

Rachel Richesson, PhDHeadshot of Rachel Richesson
Professor of Learning Health Sciences, University of Michigan Medical School
Electronic Health Records Core Co-chair

 

Related

Living Textbook Chapter: Endpoints and Outcomes: Inpatient Endpoints in Pragmatic Clinical Trials

Collecting and Sharing Patient-Reported Outcomes in the PPACT Trial

Collecting and Sharing Patient-Reported Outcomes in the PPACT Trial

Description

In this video, Dr. Lynn DeBar, PI of the PPACT trial describes how her team used electronic health records to collect and share patient-reported outcomes.

Biography

Headshot of Lynn DeBar, PhD, MPHLynn DeBar, PhD, MPH
Kaiser Permanente Washington Health Research
PPACT NIH Collaboratory Trial PI

 

Related

Incorporating PRO Data Into the EHR

View the full Grand Rounds video: Experiences From the Collaboratory PCTs.

Return to the complete collection of EHR Workshop video modules.

Data Infrastructure for Implementing the PROVEN Trial

Data Infrastructure for Implementing the PROVEN Trial

Description

In this video, Dr. Vince Mor, Co-Principal investigator of the PROVEN trial, shares the data infrastructure that was essential to implementing and monitoring PROVEN.

Biography

Photo of Vincent Mor

Vince Mor, PhD
Florence Pirce Grant University Professor of Health Services, Policy and Practice, Professor of Health Services, Policy and Practice, Brown University
PROVEN NIH Collaboratory Trial co-PI

 

Related

Acquiring Claims Data and CMS Research-Identifiable Files

View the full Grand Rounds video: Experiences From the Collaboratory PCTs.

View the complete collection of EHR Workshop video modules.

National Health IT Priorities for Research – A Policy and Development Agenda

Dr. Teresa Zayas-Cabán of the Office of the National Coordinator for Health Information Technology describes the challenges and opportunities of data quality, access, and management as electronic health data become more widely available for research.

🔙 Return to the complete collection of EHR Workshop video modules.