The industry perspective on the inclusion of women in clinical trials.
The author emphasizes that while women are currently included in clinical trials, more effort must be made to include them in ways that will provide more appropriate and specific information (for example, by including them in earlier phases of trials when possible) and to perform proper analyses that take into account factors of gender and age. Although it is generally agreed that there needs to be more emphasis on determining how to study drugs that may be important for use in women, there is no consensus on what the appropriate proportion of women in trials should be or how early young women should and can be included in trials. The strategies to answer the need for more data about women must be supported by a clear scientific rationale rather than fashioned to meet arbitrary quotas. The author outlines the complex drug development process, describes some of the factors that may affect the data acquired as drugs are studied, provides an overview of reproductive and teratology testing, describes the Food and Drug Administration's proposed guidelines for the inclusion of women in clinical trials, discusses issues of the cost of drug development, states the problems of recruitment and retention of women in trials, and reflects upon the complex issues of liability and ethics that arise when women of childbearing potential are included in clinical trials. She concludes with a summary of the key issues affecting women's participation in trials, a list of suggested strategies for the inclusion of women in trials, and an indication of areas where further discussion and resolution are needed.(ABSTRACT TRUNCATED AT 250 WORDS)
Bush
J K
JK
Bristol-Myers Squibb Co., Princeton, NJ 08543-4000.
D032761:Animal Experimentation; D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D004345:Drug Industry; D005260:Female; D005333:Fetus / Q000187:drug effects; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent; D016365:Liability, Legal; D026706:Paternalism; D018579:Patient Selection; D011247:Pregnancy; D037841:Pregnant People; D012107:Research Design; D035842:Research Subjects; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration; D016387:Women's Health