Women and clinical trials: Italian experiences

The exaggerated respect for human dignity, kingpin of all the national and international normative-ethical-deontological interventions, has led to some paradoxical situations of lacked health protection for some unprivileged people. Examples are children and women, above all pregnant women, for which some off-label drugs, because of the restrictive rules, are used but they are not supported by scientific evidence, result of ad hoc experimentation. The problems raised by such an approach, are not only of ethical nature, but also clinical, because the health of the female population is at risk due to bad management, that exposes it to possible dangers of adverse reactions at the moment of the assumption of new drugs after their placement on the market. Women are involved in clinical trials not only as subjects on which the research is made but also as active promoters of the same. There were numerous initiatives to promote the women's activities. Women deal with problems connected to women's health. The work comes through the experience of the Ethics Committee for the Biomedical Activities of the Federico II University of Naples and it is determined to value how many researches have been led on women and which drugs have been most tested on them in the first three-year application period (2003-2007) of the Order in Council No. 211/03. Beside, we verify if international trend on women which work in clinical trials research will be confirmed in Italy, using clinical trials that have been streamed, from 2003 to 2007, to the sum Ethics Committee.