title: The evaluation of pharmacologic therapy in humans: a brief summary of the drug evaluation process and guidelines for clinical trials as they related to women.
abstract: Significant progress has been made in including women in clinical and drug evaluation trials. Nonetheless, for most drugs currently on the market, analysis of benefits by sex is not available. At least some of the adverse effects of newer drugs in women could be due to the lack of inclusion in studies from which therapeutic regimens were derived. The data currently available on potential sex differences in pharmacokinetics and pharmacodynamics are also limited by having been obtained from healthy subjects receiving only one medication in studies designed only to detect moderate-to-large (> 30-50%) differences between the sexes. The clinical environment is different: patients consume multiple medications, including over-the-counter medications as well as nutraceuticals and dietary supplements; patients are, on average, older than healthy volunteers or even patients enrolled in investigational studies; and patients are more likely to have multiple diseases. In addition, adequate numbers of women still have not been enrolled in clinical trials for the therapy of many common disorders. The prudent clinician will remember that every time a therapy is initiated for an individual patient, especially a female patient, it is a clinical trial and the outcome is uncertain.
authors.affiliation: Long-Term Care Research Center, Goldman Institute on Aging/Jewish Home, 302 Silver Ave, San Francisco, CA 94112, USA.
authors.forename: J B
authors.initials: JB
authors.lastname: Schwartz
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D004353:Drug Evaluation, Preclinical / Q000592:standards; D005260:Female; D006801:Humans; D020748:Mibefradil / Q000009:adverse effects; D009135:Muscular Diseases / Q000139:chemically induced; D009316:National Institutes of Health (U.S.) / Q000592:standards*; D017410:Practice Guidelines as Topic; D011725:Pyridines / Q000009:adverse effects; D012737:Sex Factors; D014481:United States; D014930:Women; D016387:Women's Health
chemical_list: D011725:Pyridines; D020748:Mibefradil; C086276:cerivastatin