The Tumultuous History Of Women's Involvement In Clinical Research

By Jennifer Dennis-Wall, Ph.D.

Inclusion of women in clinical research has a surprisingly colorful history. As you can probably imagine, inequality is present throughout, but for reasons that may not be so intuitive.

If you haven’t heard of the thalidomide crisis, here is a brief synopsis. In 1957, thalidomide was put on the market in Germany and a few other countries to treat morning sickness and other ailments. Then, throughout the next few years, thousands of babies suffered from severe birth deformities or early death. The birth deformities were attributed to thalidomide, and the drug was removed from the market in most places. Many countries took this crisis very seriously and subsequently reviewed and revised their regulations surrounding pharmaceuticals and clinical trials. Something most people may not know is that in 1977, the FDA released a recommendation called “General Considerations for the Clinical Evaluation of Drugs” that more or less prevented women of “childbearing potential” from participating in phase I and II clinical trials because of the “risk of pregnancy” and subsequent risk of harm to a fetus.

And then the pendulum swung. In 1988 and in the years thereafter, many different initiatives began to advocate for the inclusion of women in clinical research. But have these initiatives changed anything?