Healthy Skepticism Library item: 10701

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Califf RM; CERTs Benefit Assessment Workshop Participants.
Benefit assessment of therapeutic products: the Centers for Education and Research on Therapeutics.
Pharmacoepidemiol Drug Saf 2007 Jan; 16:(1):5-16
http://www3.interscience.wiley.com/cgi-bin/abstract/112466944/ABSTRACT?CRETRY=1&SRETRY=0

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.

Keywords:
Publication Types: Research Support, U.S. Gov't, P.H.S. Review MeSH Terms: Drug Industry/legislation & jurisprudence Drug Industry/standards Humans Pharmaceutical Preparations/adverse effects* Policy Making Risk Assessment/methods* United States United States Government Agencies Substances: Pharmaceutical Preparations