RWE Masterclass 3: ‘Non-randomised comparative studies’
Non-randomised comparative studies will be the main topic of the next session of our Real-World Evidence Masterclass Series.
This Masterclass mini-series are meant for attendees to learn about perspectives on RWE studies with the help of two experts in this particular field: Professor Stuart Pocock, renewed trialist and statistician, and Nawab Qizilbash, epidemiologist and clinician.
Session 3: ‘Non-randomised Comparative Studies’, will take place on Wednesday, 19 May 2021 at 5 pm CEST
SUMMARY:
Approval of new drugs is often conditional on data collection and secondary data PASS studies. How do non-randomised comparative safety studies compare with randomised trials?
How may the challenges of these designs be overcome?
MAIN TOPICS:
- Pros and cons of non-randomized studies of interventions for safety.
- Practical implications for studies of low exposure and rates and long latency periods for adverse events.
- Examples of safety studies.
- Evaluating safety of drug exposure in pregnancy.
- Types of Real-World Data (RWD) for safety studies.
- Data quality and completeness.
- Guidance on conducting PASS studies.
This series is addressed to Epidemiology, HEOR, Safety, Statistics, Medical Affairs, Market Access, Marketing, Project Management and Outsourcing professionals in biopharmaceutical and device companies interested in learning about the role of Real-World Data studies and their pros and cons compared with trials.
*Due to the proprietary nature of the content, all registrations are at the discretion of OXON EPIDEMIOLOGY.