Product Details

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 report walks 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.

Who Will Benefit

• Clinical project specialists
• Clinical research associates
• Compliance officers
• Consultants/service providers
• Data management and statistics personnel
• Executive management
• General/corporate counsel
• Investigators
• Managers
• Manufacturing directors and supervisors
• R&D staff
• Regulatory/legislative affairs professionals
• Risk management specialists
• Strategic planning and business development staff
• Study monitors
• Study research coordinators
• Study sponsors