Evelyn, B., Toigo, T., Banks, D., Pohl, D., Gray, K., Robins, B., Ernat, J.
June, 2001
Office of Special Health Issues
Office of International and Constituent Relations
Office of the Commissioner
U.S. Food and Drug Administration
Rockville, Maryland 20857
Context: There continues to be a perception that women are under-represented in clinical trials of new drugs. Few data are available from formal evaluations of approved new drug applications. This study reviews women’s participation in clinical trials and gender-related labeling for new molecular entities approved during a five-year period by the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).
Objectives: The objectives of the study were to assess to what extent women participated in clinical trials, to describe what FDA medical officers concluded about gender differences in sponsors’ evaluations, and to determine to what extent sponsors described gender-related information in the approved product labeling.
Design: This was a retrospective review of clinical trial protocols and labeling for 185 new molecular entities approved by CDER between January 1, 1995, and December 31, 1999. Enrollment data were derived from medical officers’ reviews and tabulated according to gender. The approved product labeling was searched for statements related to product use in humans. All data were compiled and analyzed using Microsoft Access.
Main Outcome Measures: This study quantifies women’s participation as described by enrollment data in clinical trials by year, phase of study, and product type as defined by the CDER division responsible for the product review. Additionally, the study categorizes labeling based on the inclusion of gender-specific information.
Results: Overall, women appear to participate in the clinical trials at nearly the same rate as men even when gender-specific products are excluded. Some differences in participation are seen when year-to-year or division-to-division comparisons are made. Labeling for two-thirds of the products contained some statement about gender, although only 22% described actual gender effects. Four labels described more than one gender effect. Ninety percent (90%) of the effects discussed in the labeling were pharmacokinetic, 12% were safety, and 5% were efficacy. No product recommended a change in dosage for women.
Conclusions: Women are participating in clinical trials of new drugs in approximate proportion to their representation in the population. The majority of product labeling contains references to gender evaluation. Most of the gender effects were pharmacokinetic. Few products demonstrated safety or efficacy effects, and none recommended changes in dosage based on gender effects.
Full Article :
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ParticipatinginClinicalTrials/ucm197788.htm