NSABP Members' Area
Password Protected - Access
Limited to NSABP Participating
Institutions Only
NSABP Foundation, Inc.
General NSABP Information
Financial Conflicts of
Interest Policy
Contact the NSABP
Employment
Clinical Trials Information
Clinical Trials Overview
Protocol Chart
Never Say Lost
Treatment Trials Information
Protocol B-51
Protocol B-52
Protocol B-53/S1207
Protocol B-55/BIG 6-13
Prevention Trials Information
Protocol P-1 - BCPT
Protocol P-2 - STAR
To report problems, ask
questions or make comments,
please send e-mail to:
Webmaster@nsabp.pitt.edu
Benefit/Risk Assessment of SERM Therapy: Clinical Trial Versus Clinical Practice Settings
Costantino JP
Annals of the New York Academy of Sciences 949:280-285 December, 2001
Abstract
Benefit/risk assessment (B/rA) can be used in a variety of circumstances encompassing clinical practice and research settings. Subsequent to the reporting of the results from the Breast Cancer Prevention Trial (BCPT), methodology was developed to perform B/rA for the use of the selected estrogen receptor modulator (SERM), tamoxifen. Although the methodology was specifically developed and applied to the use of tamoxifen, it is a generalized procedure that can be readily modified and applied to other forms of therapy including other SERMs. Recently, the methodology has been incorporated into the Study of Tamoxifen and Raloxifene (STAR) trial, a randomized clinical trial designed to compare the chemopreventive effects of two SERMs--tamoxifen and raloxifene. The B/rA of SERMs is complex because SERMs are known to exhibit properties that can reduce or increase the incidence of several health outcomes. This paper summarizes the uses of B/rA in the clinical practice and clinical trial settings and describes the constraints of the methodology as it is being applied to the assessment of therapy with SERMs.
Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.