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Benefit assessment of therapeutic products: the Centers for Education and Research on Therapeutics
Author(s) -
Califf Robert M.
Publication year - 2007
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.1215
Subject(s) - formulary , operationalization , medicine , risk analysis (engineering) , risk management , risk assessment , quality (philosophy) , management science , process management , pharmacology , business , computer science , engineering , philosophy , computer security , epistemology , finance
The ability to manage risk depends critically on an understanding of the degree to which a known risk is balanced by the probability of a clinical benefit. Despite the massive emphasis on risk and risk management in the past few years and the long‐term focus on defining benefit in the regulatory system, considerable uncertainty remains about the methods of defining benefit and how to operationalize this knowledge. In this ‘think tank,’ part of a larger series on risk management, issues were divided into those that can be identified before a study is initiated, those that commonly arise after a study is completed, biomarkers and surrogates, use of benefit findings in defining quality and performance indicators, implementation of findings into health systems and formularies, and methods of comparative trials. Key categories for the establishment of a research agenda to fill in gaps in our understanding of assessing benefit were developed by the group. Copyright © 2006 John Wiley & Sons, Ltd.