THE INDUSTRY PERSPECTIVE ON THE INCLUSION OF WOMEN IN CLINICAL-TRIALS

The author emphasizes that while women are currently included in clini cal trials, more effort must be made to include them in ways that will provide more appropriate and specific information (for example, by in cluding them in earlier phases of trials when possible) and to perform proper analyses that take into account factors of gender and age. Alt hough it is generally agreed that there needs to be more emphasis on d etermining how to study drugs that may be important for use in women, there is no consensus on what the appropriate proportion of women in t rials 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 m ust be supported by a clear scientific rationale rather than fashioned to meet arbitrary quotas. The author outlines the complex drug develo pment process, describes some of the factors that may affect the data acquired as drugs are studied, provides an overview of reproductive an d teratology testing, describes the Food and Drug Administration's pro posed guidelines for the inclusion of women in clinical trials, discus ses issues of the cost of drug development, states the problems of rec ruitment and retention of women in trials, and reflects upon the compl ex issues of liability and ethics that arise when women of childbearin g potential are included in clinical trials. She concludes with a summ ary of the key issues affecting women's participation in trials, a lis t of suggested strategies for the inclusion of women in trials, and an indication of areas where further discussion and resolution are neede d. She emphasizes the importance of including physicians and others fr om the pharmaceutical industry in any discussions of this topic, and r eiterates that the industry is committed to fostering the cause of inc lusion of women in trials in the most appropriate and workable fashion .