The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium

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The 21st Century Take on Observational Studies
Using Real-World Evidence in the New Millennium

Passage of the 21st Century Cures Act reaffirmed Congress’s and the FDA’s commitment to using real-world evidence to supplement or even replace traditional clinical trials.

More flexible, faster and cheaper research methods, including observational studies, are now acceptable in the FDA’s approval process.

Observational research requires an entirely different set of procedures and careful planning to ensure the real-world evidence collected is valid and reliable.

The 21st Century Take on Observational Studies 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:

  • Provisions of the 21st Century Cures Act related to observational studies and gathering of real-world evidence
  • 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.

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Note: This publication will be available in PDF format by Nov. 20, 2017.

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  • Regulatory/legislative affairs professionals
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  • Strategic planning and business development staff
  • Study monitors
  • Study research coordinators
  • Study sponsors

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