Trials in women

Abstract

Women of childbearing age have been viewed as a ‘vulnerable population’ and have been systematically excluded from early clinical trials. A change in attitude and policies occurred in the last decade, with a consequent increase of women participating in clinical trials. The implications are increasing respect for the woman's capacity to make her own risk–benefit choices, early evaluation of patients that represent the ultimate user of a drug and equal opportunities for women to benefit from the therapeutic potential of new drugs. Drug trials should be designed to identify sex-related effects and to analyse the efficacy and tolerability of antiepileptic drugs (AEDs) by gender. Further aspects should be considered, including changes in response in relation to the menstrual cycle and over the various stages of reproductive life; interactions between hormonal therapies and AEDs; the effect of AEDs on reproductive function and possible consequences of prenatal exposure to AEDs. These considerations become even more critical when pregnant and lactating women are considered, since any risk for the offspring is unacceptable unless drug administration is likely to have major medical benefits for the mother.