In response to a New York Times report on the dearth of women enrolled in H.I.V. clinical trials, Ruth Merkatz, director of clinical development at the Population Council’s Center for Biomedical Research and former director of the Office of Women’s Health at the FDA, wrote a letter to the editor about the essential need for gender equality in clinical trials.
Merkatz notes that, while strides were made while she was at the FDA to include women in clinical trials, this recent news shows that more progress is needed.
In 1993, at the height of the H.I.V.-AIDS epidemic, several of us at the Food and Drug Administration fostered major change in clinical trial protocols: We removed a longstanding ban on the participation of women with childbearing potential in early-stage clinical trials.
Including these women was heralded as a major advance. Since then, the F.D.A. has encouraged, if not mandated, female participation and analysis of safety and efficacy data based on sex. But clearly these actions haven’t been enough. We must stop excluding women based on their reproductive status.
The F.D.A., clinical developers and clinical sites need to do more to bring women into the process. For more than two decades, drug developers and investigators have had a mandate to enroll representative patient populations. Only by including women of all ages in trials can we develop products intended to meet women’s needs.
Read more at the New York Times.