Women and the development of drugs: why can't a woman be more like a man?
Most health providers and researchers would agree that the FDA provides the finest and safest methods to ensure safety and efficacy for the consumer. All proposed regulations or changes are published in the Federal Register (Title 21 Code of Federal Regulations). The 70 kg white male is no longer considered the norm. Any differences in race, gender, and ethnic composition need to be identified. Accessibility of clinical trial subjects has been a key factor in the inclusion of patients in studies as exemplified by the use of male medical students, male prison subjects, and male Veterans' Administration patients. This is no longer satisfactory; efforts now must be made to encourage and include representative women in each study. Woman scientists must now accept this challenge in education and leadership roles to ensure the proper representation of women in clinical studies.
Fourcroy
J L
JL
Department of Surgery, Uniformed Services University of Health Sciences, Bethesda, Maryland 20814, USA.
D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000266:history*; D005260:Female; D049672:History, 19th Century; D049673:History, 20th Century; D006801:Humans; D007880:Legislation, Drug / Q000266:history*; D008297:Male; D004366:Nonprescription Drugs / Q000266:history; D015983:Selection Bias; D014481:United States; D014486:United States Food and Drug Administration
D004366:Nonprescription Drugs