Simplifying Global Compliance
Observational Research - Webinar CD/Transcript
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Observational Research: Gathering Evidence in the 21st Century
The 21st Century Cures Act promises to usher in a new era of drug development by dramatically lowering the cost of clinical trials while speeding the path to market.
The Act lets drugmakers substitute observational data and “in house” registry data in place of new, randomized clinical trial data. But much remains unclear. Would you be confident defining:
- What exactly constitutes ‘significant evidence’?
- What level of statistical strength are regulators looking for?
- When is a data point merely an anecdote?
To take full advantage of the Cures Act, you need answers now. And FDAnews is providing them.
Noted researcher Jeff Trotter shows you how to take full advantage of the Cures Act and start reducing drug trial costs today. In a mere 90 minutes, Mr. Trotter brings you up to speed on:
- The FDA’s fast-evolving views on the health-improvement and the cost-saving potential of observational studies and patient registries
- Case studies of patient registries and observational studies — the well-designed vs. the poorly designed
- Tips for using effectiveness, safety, HRQoL, satisfaction and resource utilization data to make your case to regulators and payers
- Best practices for building study teams capable of managing comparative effectiveness research (CER) and health economics and outcomes research (HEOR)
- And much more!
Join the 21st Century! Start taking full advantage of the Cures Act and reap dramatic benefits — lower costs for clinical trials, speedier drug approvals, greater profits. Order now.
- Executive management
- Manufacturing executives
- Compliance officers
- R&D
- Strategic planners/business developers
- Risk managers
- Regulatory/legislative affairs
- Data management/statistics
- Clinical project specialists
- Clinical research associates
- Consultants/service providers
- General/corporate counsel
- Study monitors/research coordinators
- Study sponsors
- Legal counsel
- Consultants
Jeff Trotter, President, Continuum Clinical
Jeff Trotter has enjoyed a diverse career in the healthcare industry spanning the past 30 years. As an entrepreneur, researcher, consultant, and innovator, Jeff has been a pioneer in the evolving health economics and outcomes research community, and is an industry leader in the design and implementation of research studies generating “real world” evidence. Having engineered the acquisition of his internationally known research and consulting firm, Ovation Research Group, Jeff has been in executive management with other global clinical research organizations, has spoken widely in front of varied industry audiences and has published over 50 original articles and research papers.
