NSABP Members' Area
  Password Protected - Access
  Limited to NSABP Participating
  Institutions Only


NSABP Foundation, Inc.



General NSABP Information
  Financial Conflicts of
     Interest Policy
  Coalition Comment:
     Reconfiguration
  IOM Report Group Comment
  Contact the NSABP
  Pathology Section
  Future Meetings
  NSABP Newsletters
  Media Info on STAR
  Employment

Clinical Trials Information
  Clinical Trials Overview
  Protocol Chart
  Never Say Lost

Treatment Trials Information
  Protocol B-43
  Protocol B-47
  Protocol B-51

Prevention Trials Information
  Protocol P-1 - BCPT
  Protocol P-2 - STAR
  Protocol P-5
  BreastCancerPrevention.com

Scientific Publications

Related Web Sites



Medical Search Engines



To report problems, ask
questions or make comments,
please send e-mail to:
Webmaster@nsabp.pitt.edu

Annotated Bibliography of NSABP Publications


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.