The 21st Century Take on Observational Studies Using Real-World Evidence in the New Millennium
Many companies have taken their first steps in the frontier of real-world evidence and what they have learned may surprise you.
This new edition of The 21st Century Take on Observational Studies presents new information on the encouraging results those pioneers have found. New to this edition are the results of a groundbreaking study from Tufts University’s Center for the Study of Drug Development. Learn how your colleagues — and competitors — are using real-world data to advance their products.
The management reportwalks you through everything you need to know about the opportunities and pitfalls observational studies can offer. The report looks at the growing trend toward observational research and how provisions in the 21st Century Cures Act create even more incentives to rely on real-world evidence in the development of medical products. The report covers:
The evolution of patient-focused research
How observational studies can be used in the preapproval and postmarket stages
The potential for saving time and money
New data sources that make observational studies a viable alternative to clinical trials
How drug- and devicemakers view observational research and how they are using it
Order your copy of The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium and learn effective uses of observational studies in both the preapproval and postmarket phases; how to identify stakeholders and determine what kind of data they needed, and how the FDA’s view on observational research is evolving.
Order Your Copy Today
PDF Edition — $99
Who Will Benefit
Clinical project specialists
Clinical research associates
Data management and statistics personnel
Manufacturing directors and supervisors
Regulatory/legislative affairs professionals
Risk management specialists
Strategic planning and business development staff
Study research coordinators
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.