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U.S. Department of Health and Human Services

Science & Research

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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.

 

Figure 1. Gender Studies

 

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