On Demand Content Preview Webinar: Operationalizing Master Protocols Encore Presentation
This on demand recording will take approximately 1 hour to complete
The modernization of clinical trials is driven by the need to address important clinical questions more efficiently while decreasing costs. Master protocols (including basket, umbrella, and platform trials) provide a method to answer multiple questions in one overarching trial structure. Although these trials require more planning, coordination and upfront investment in creating an infrastructure for execution, they provide an opportunity to more efficiently address a broader set of objectives than would be possible in an independent trial.
During this webinar, we consider this emerging family of clinical trial designs within the context of broader efforts to increase efficiency, effectiveness, and quality in the development paradigm.
- Master Protocols; Design and Execution Considerations
- Utilizing the TransCelerate Common Protocol Template for Novel Clinical Trial Designs, Such as Platform Trials
- Statistical Analysis Opportunities and Challenges with Master Protocols
Who should attend?
Professionals who work in the area of:
- Biostatistics, including Adaptive Design and Bayesian Statistics
- Clinical Research
- Research and Development
- Trial Design
- Clinical Operations
- Therapeutic Area Development, Management, and Operationist
- Rare disease, oncology, immunology, Alzheimer’s disease
- Medical Affairs
- Medical Science Liaisons
- Medical Writing
- Regulatory Affairs
At the conclusion of this on demand content preview webinar, participants should be able to:
- Analyze different trial designs that can be described and executed under a master protocol (including umbrella, basket and platform)
- Describe considerations and challenges for master protocol development
- Discuss a case example for using the common protocol template basket studies
- Identify critical elements around data collection, analysis, and interpretation
Continuing Education Credits are not available for this event.