March has been designated Women’s History Month in the United States by Presidential Proclamation. This recognition started from a successful Women’s History Week in 1978. This was planned to coincide with International Women’s Day, which is observed annually on March 8th.
We at Seascape Clinical are particularly pleased to recognize the movement since our company also happens to be woman-founded. Connect with our co-founder on LinkedIn!
This month we will explore the topic of Women’s History, and the relevance of women in Clinical Operations.
Honoring Women in STEM
To commemorate Women’s History Month, we’d like to take a moment to honor the lives of some great women. And since we are a technology company in the clinical trials space, we especially want to recognize some who are or were pioneers in the fields of Science, Technology, Engineering and Math (STEM).
- Katherine Johnson – NASA research Mathematician and inspiration behind the movie Hidden Figures. Her inputs were critical to the success of US spaceflights into the Earth’s orbit and to the moon.
- Grace Hopper – Computer scientist and pioneer in Computer programming. One of her most famous quotes – “You don’t manage people, you manage things. You lead people.”
- Mae C. Jemison – a physician, engineer and the first African American female astronaut. In 1992, she flew into space aboard the Endeavour, becoming the first African American woman in space.
- Sally Ride – Astronaut and First American Woman in space, third woman in space overall.
- Chien-Shiung Wu – Chinese-American experimental physicist, discovered the chemical element Promethium – Pm(61)- and contributed to the development of the process that separates uranium isotopes.
- Linda Buck – American Biologist, 2004 Nobel Prize winner in Physiology or medicine (along with Richard Axel) for their work on olfactory receptors. (Important nowadays given one of the markers of COVID-19!)
We salute these women who shone brightly, and cleared a path for other women and girls with interest in the STEM fields.
The Inclusion of Women as Participants in Clinical Research
We also want to take time to acknowledge another important concept that hits close to home – female representation among participants in clinical research.
Historically, women were severely underrepresented among people working in either medicine or science. Maybe as a consequence of this, up until the late 1970s, women were excluded from clinical trials.
To be fair, this approach was driven by the tragedies derived from the use of thalidomide during pregnancy, which resulted in the birth of children with severe limb deformities. While the original rationale for limiting female participation in clinical trials might have been a noble one, the resulting decisions led to a shortage of data on how drugs affected women. This precipitated some other wide-ranging concerns.
Nowadays, patient recruitment using specific demographic criteria is an important part of what we do in Clinical Operations. Clinical trials today must include and report on findings across gender and ethnicities by ensuring that key enrollment criteria are strictly observed and met. Let’s review the series of events and policy changes over the years that led to the inclusion and representation of women in clinical trials today.
A Historical Timeline of Women's Participation in Clinical Trials
1962 – Thalidomide was found to cause birth defects in thousands of babies across Europe.
1977 – The FDA recommends excluding women of child bearing potential from Phase I and II clinical trials.
1985 – A report on the Public Health Service Task Force on Women’s Health recommended the need for conducting research and evaluation on issues related to women’s health.
1986 – 1989 – NIH established policies designed to encourage the inclusion of women in clinical trials. In fact, these policies specified that if women were excluded, rationale had to be provided.
1991 –Dr. Bernadine Healey became the first director of the NIH and launched the Women’s Health Initiative, whose purpose was to study the specific health needs of women.
1993 – Inclusion of women in studies finally becomes Federal law (Public Law 103-43) as part of the NIH Revitalization Act, with its exact policy titled Women and Minorities as Subjects in Clinical Research.
1993 – current – All clinical studies are required to examine differential effects based on gender and ethnicities.
