Abstract #302055

This is the preliminary program for the 2003 Joint Statistical Meetings in San Francisco, California. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 2-5, 2003); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

To View the Program:
You may choose to view all activities of the program or just parts of it at any one time. All activities are arranged by date and time.

The views expressed here are those of the individual authors
and not necessarily those of the ASA or its board, officers, or staff.

Back to main JSM 2003 Program page
JSM 2003 Abstract #302055
Activity Number: 160
Type: Invited
Date/Time: Monday, August 4, 2003 : 2:00 PM to 3:50 PM
Sponsor: General Methodology
Abstract - #302055
Title: Statistical, Clinical, and Regulatory Perspectives on the Women's Health Initiative Study of Postmenopausal Hormones
Author(s): Garnet L. Anderson*+ and Ross L. Prentice*+ and Steve Cummings*+ and Scott Monroe*+
Companies: Fred Hutchinson Cancer Research Center and Fred Hutchinson Cancer Research Center and University of California, San Francisco and Food and Drug Administration
Address: 1100 Fairview Ave. N, MP 1002, Seattle, WA, 98109-1024, 1100 Fairview Ave. North, Seattle, WA, 98109-4433, SF Corrdinating Center, Suite 600, San Francisco, CA, 94105, Division of Reproductive and Urologic Drug Products, Rockville, MD, 20857,
Keywords: randomized trials ; observational studies ; menopausal hormones ; women's health
Abstract:

The role of postmenopausal hormones in women's health has undergone a rapid and dramatic reassessment following the early termination of the Women's Health Initiative (WHI) randomized trial of estrogen plus progestin in July 2002. This trial was launched based on considerable observational data showing a strong protective effect on coronary heart disease (CHD) incidence, supported by intermediate outcome trials and animal studies and showing benefit for lipid profiles and atherosclerosis, respectively. Observational studies also were generally consistent in showing benefit for osteoporosis and an adverse effect on breast cancer. Though some felt the trial was not justified in the face of the impressive evidence for CHD benefit, the need to establish the overall balance of risks and benefits provided a compelling rationale. The WHI trial was stopped early after the independent Data and Safety Monitoring Board observed an increase in breast cancer incidence that exceeded the predefined stopping boundary and a global benefit versus risk assessment index that supported overall harm, primarily due to a modest but consistent increase in rates of CHD, stroke, and pulmonary embolism. In this session we will summarize the design, early stopping, and primary results of the trial. Panel participants representing the statistical, clinical, and regulatory communities will discuss the public health importance and policy implications of the findings.

  • The address information is for the authors that have a + after their name.
  • Authors who are presenting talks have a * after their name.

Back to the full JSM 2003 program

JSM 2003 For information, contact meetings@amstat.org or phone (703) 684-1221. If you have questions about the Continuing Education program, please contact the Education Department.
Revised March 2003