Contents

• BOARD ON HEALTH SCIENCES POLICY
• Inclusion of Women in Clinical Trials: Policies for Population Subgroups
  • INTRODUCTION
  • BACKGROUND
  • PARTICIPATION IN CLINICAL TRIALS WITH SPECIAL REFERENCE TO WOMEN
  • HAVE CLINICAL TRIALS EXCLUDED OR UNDERREPRESENTED WOMEN?
  • BARRIERS TO FULL PARTICIPATION OF WOMEN IN CLINICAL TRIALS
  • HOMOGENEITY VERSUS HETEROGENEITY
  • INTERPRETATION OF AN UNEXPECTED OBSERVED DIFFERENCE BETWEEN MEN AND WOMEN
  • CONCLUSION
• REFERENCES

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are draw from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of member of the National Academy of Sciences, the National Academy of Engineeing, and the Institute of Medicine.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate profession in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Science by its congressional charter to be an adviser to the federal government and, upon its own initiative to identify issues of medical care, research, and education Dr. Kenneth I.Shine is president of the Institute of Medicine.