Benefit assessment of therapeutic products: the Centers for Education and Research on Therapeutics.

Abstract:

: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.

authors

Califf RM,CERTs Benefit Assessment Workshop Participants.

doi

10.1002/pds.1215

keywords:

subject

Has Abstract

pub_date

2007-01-01 00:00:00

pages

5-16

issue

1

eissn

1053-8569

issn

1099-1557

journal_volume

16

pub_type

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