Real-world evidence (RWE) is revolutionizing healthcare, but harnessing the power of routine patient health records for regulatory-compliant RWE studies presents unique challenges.
This webinar explores the key differences between clinical trial data and real-world data, and how to bridge this gap to ensure robust and reliable RWE that meets the threshold of regulatory grade.
Key Topics Include:
- Understand the inherent differences between clinical trial and real-world data collection methodologies
- Address selection bias and ensure the inclusion of the right patients for your RWE study
- Evaluate the similarity of real-world data to clinical trial data, and the role of analytics in ensuring data quality and reliability of study results
- Review best practices for these RWE challenges to ensure that your data meets regulatory requirements
Presenters
Liz Mearns
Liz Mearns, PharmD currently serves as a Director of Business Development, Real-World Data and Evidence at Cardinal Health. Prior to joining Cardinal Health, Liz was a health economist with over 12 years of experience in academia, industry, and global consulting. She has demonstrated excellence in providing strategic guidance, robust RWE development and cross-functional collaboration.
Harlen Hays
Harlen D. Hays, MPH serves as the Senior Director of Scientific Operations and Research Analytics. He directs a team of senior statisticians and data scientists in the conduct of statistical analysis (and database management) of real-world data from medical chart reviews, administrative claims databases, electronic medical record databases, and other sources for biopharmaceutical manufacturers seeking to generate real-world evidence for internal and payer projects, medical communications, and regulatory bodies.
Andy Klink
Andy Klink has over 15 years of experience in academia and industry with health economics and outcomes research, multi-level mixed-effects analysis, longitudinal analysis, comparative effectiveness, and patient-oriented research. Serving as strategic scientific oversight and business development, Dr. Klink currently supports industry-sponsored research studies involving administrative claims data, electronic health records, chart reviews, and patient and physician surveys to assess healthcare resource utilization, costs, quality of life, treatment patterns, treatment response, and other clinical and patient-centered outcomes.
Bruce A. Feinberg
Bruce Feinberg, D.O., is Vice President, Clinical Affairs and Chief Medical Officer for Cardinal Health Specialty Solutions. He is nationally recognized for his expertise in specialty oncology and the business of specialty healthcare.
Sponsor
