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

50 Pages·2019·1.105 MB·English
by  FDAnews
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by FDAnews| 2019| 50 pages| 1.105| English

About 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 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

Detailed Information

Author:FDAnews
Publication Year:2019
ISBN:9781604300932
Pages:50
Language:English
File Size:1.105
Format:PDF
Price:FREE
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