IN SUMMARY
The 1995 Gender Workshop provided an opportunity to review the 1993
Guideline and to consider the need to provide further clarification. While
there is now a widespread consensus that important scientific questions
about gender-based biology and other population group effects can be addressed
by appropriate clinical trial designs, much more scientific information
and research is needed in all areas of drug development to delineate the
best possible approaches. Questions about the hormonal effects of drugs
and pharmacokinetic and pharmacodynamic gender differences are not easy
to resolve. An especially valuable area of focus might be whether in vitro
studies in human tissues can be used predictively to rule in or rule out
a possible gender effect. If successful, the capability of using these
relatively low-cost approaches in a predictive way might ultimately reduce
clinical trial costs. By learning more about gender effects, we will also
be able to understand better about how medical therapies work, not only
in population subsets, but also in the overall population. The need to
clarify and refine basic principles of study design also becomes apparent
as the best approaches to develop useful gender information are sought.
Drawing on the deliberations of the 1995 Gender Workshop and working collaboratively
with academia, industry, government, and other individuals and groups,
FDA expects to identify further information and recommendations to assist
sponsors in defining when a gender or other population group effects are
clinically important.
Speakers List
Claudette Bain
HIV Law Project
Janice K. Bush, M.D.
Vice President
Janssen Research Foundation
Louis R. Cantilena, Ph.D., M.D.
Director, Division of Clinical Pharmacology University Services
University of the Health Services
Joy Cavagnaro, Ph.D.
Special Assistant to the Deputy Director
Center for Biological Research and Evaluation
Food and Drug Administration
Mei-Ling Chen, Ph.D.
Chief, Pharmacokinetics Evaluation Branch
Center for Drug Evaluation and Research
Food and Drug Administration
Neal Cutler, M.D.
Director, California Clinical Trials Medical Group
Paresh Dandona, B.Sc., M.B., B.S., F.R.C.P.
Professor of Medicine
State University of New York at Buffalo Chief of Endocrinology
Millard Fillmore Hospital
Jeanne DeJoseph, Ph.D., C.M.N
Department of Family Health School of Nursing
University of California at San Francisco
David Flockhart, M.D., Ph.D. Assistant Professor of Medicine and Pharmacology Georgetown Hospital
Victoria Hale, Ph.D.
Pharmacokinetics and Metabolism
Genentech
Jean Hamilton, M.D.
Director, Institute for Women's Health
Medical College of Pennsylvania and Hahnemann University
Eugene G. Hayunga, Ph.D. Office of Research on Women's Health
National Institutes of Health
David A. Kessler, M.D.
Commissioner of Food and Drugs
Food and Drug Administration
Sarah J.H. Kogut, M.S. Triology Consulting Company
Laura Kragie, M.D.
Critical Care Center
Center for Drug Evaluation and Research
Food and Drug Administration
Scott E. Lukas, Ph.D.
Associate Professor of Psychiatry Harvard Medical School
Murray K. Lumpkin, M.D.
Deputy Director, Review Management
Center for Drug Evaluation & Research
Food and Drug Administration
Stella Machado, Ph.D.
Chief, Research RAMPS and Methodology Planning Staff
Center for Drug Evaluation & Research
Food and Drug Administration
Theresa McGovern, J.D. HIV Law Project
Ruth Merkatz, R.N., Ph.D.
Director, Office of Women's Health
Food and Drug Administration
Robert O'Neill, M.D.
Director, Office of Epidemiology and Biostatistics
Center for Drug Evaluation & Research
Food and Drug Administration
Kimber Richter, M.D.
Deputy Director for Clinical and Review Policy
Center for Devices and Radiological Health
Food and Drug Administration
Jean Rowan, M.D.
Senior Director
Parke Davis
Janice Schwartz, M.D.
Northwestern University Medical School
Lewis Sheiner, M.D.
Professor of Laboratory Medicine University of California at San Francisco
Alan Sedman, M.D., Ph.D.
Parke Davis
Richard Simon, D.Se.
Chief, Biometric Research Branch National Cancer Institute
National Institute of Health
Jean Louis Steimer, Ph.D.
F. Hoffman-La Roche, Ltd.
Julie A. Swain, M.D.
Kenosha Hospital and Medical Center DeBakey Heart Institute
Robert Temple, M.D.
Associate Director for Medical Policy
Center Drug Evaluation & Research
Food and Drug Administration
Solomon Sobel, M.D.
Director, Division of Metabolic and Endocrine Drug Products
Center for Drug Evaluation & Research
Food and Drug Administration
Carol Trapnell, M.D.
Medical Researcher, Research Resources
Center for Drug Evaluation & Research
Food and Drug Administration
Edward Wallach, M.D.
Department of Obstetrics and Gynecology
Johns Hopkins University
Roger Williams, M.D.
Deputy Director for Science and Medical Affairs
Center for Drug Evaluation & Research Food and Drug Administration
Janet Woodcock, M.D.
Director
Center for Drug Evaluation & Research Food and Drug Administration
Raymond Woosley, M.D., Ph.D. Professor and Chairman
Department of Pharmacology
Georgetown University Medical Center