Critical Issues in Women's Underrepresentation in Clinical Trials and Their Consequences
Warman O'Brien
Global Life Sciences Recruitment Partner across the USA, UK, Europe and APAC
Despite women making up nearly half of the global population, medical research has historically treated women's bodies as atypical, with men's bodies considered the norm. This bias has led to significant underrepresentation of women in clinical trials, impacting the diagnosis and treatment of conditions that predominantly affect women.
Conditions like endometriosis, menopause, breast cancer, and other female cancers often receive disproportionately less funding compared to male-dominated conditions, leading to delayed diagnosis and inadequate treatment options.
Historical Exclusion from Clinical Trials
Historically, women were excluded from clinical trials due to concerns about hormonal fluctuations and potential risks during pregnancy. The FDA's 1977 policy to exclude women of reproductive potential from early-phase clinical trials was a major setback, effectively excluding most women of childbearing age from medical research. It wasn't until 1993 that the FDA reversed this policy, mandating the inclusion of women in research unless there was a justification for exclusion.
It's hard to believe, but the official publication acknowledging that sex differences influence biology and should be studied as a variable in clinical research was only announced 24 years ago, in 2001 by the Institute of Medicine.
Funding Disparities
Research funding for women's health conditions is often not aligned with the burden of disease. For instance, endometriosis affects about 10% of women worldwide but receives significantly less funding than diabetes, which has a similar prevalence. This disparity contributes to health care disparities, as biological sex can play a role in physiological, metabolic, hormonal, and even cellular differences that influence how diseases present and the effectiveness of treatments.
An analysis of cancer funding, using data from the US National Cancer Institute over the 11 years from 2007 to 2017, showed that gynaecological cancers receive much less support than do other cancers when accounting for lethality (years of life lost for each new diagnosis). In a selection of 19 cancers, ovarian cancer ranks 5th for lethality, but 12th in terms of its funding-to-lethality ratio. Cervical cancer followed a similar pattern. For many gynaecological cancers, the ratio of funding to mortality dropped during the 11-year period.
Autoimmune Diseases
Autoimmune diseases, such as lupus, rheumatoid arthritis, and multiple sclerosis, disproportionately affect women. Approximately 80% of those diagnosed with autoimmune diseases are women, with conditions like lupus and Sjogren's syndrome showing female-to-male ratios as high as 9:1 and 19:1, respectively Stanford Medicine.
Despite this, women remain underrepresented in clinical trials for these conditions. For example, Alzheimer's disease, which affects twice as many women as men, has clinical trials that include eight times more male participants than female participants.
Impact of Underrepresentation
The underrepresentation of women in clinical trials has significant consequences, including health care disparities and increased adverse effects from medications. Women experience adverse effects from medications at twice the rate of men, partly due to inadequate testing in women. For instance, women with metal hip replacements were found to be 29% more likely than men to experience implant failure, due to anatomical differences and inadequate testing.
Recent Breakthroughs in Women's Health Research
Recent years have seen significant advancements in women's health research, with innovative treatments and diagnostic tools emerging for conditions like endometriosis, breast cancer, menopause, and other female cancers, offering new hope for improved health outcomes.
1. Endometriosis:
2. Breast Cancer:
3. Menopause:
4. Other Female Cancers:
Companies Investing in Women's Health Research
In the US, UK, and Europe, several pharmaceutical and biotech companies are leading investments in women's health research:
1. Pfizer: Known for its extensive research in breast cancer and menopause treatments.
2. Merck: Invests heavily in HPV vaccines and cervical cancer prevention.
3. Novartis: Focuses on innovative treatments for menopause and endometriosis.
4. Roche: Leads in ovarian cancer research and targeted therapies.
5. GSK: Invests in cervical cancer vaccines and treatments.
The underinvestment in women's health research and clinical trials is a critical issue that affects not only women's health outcomes but also the broader economy. At Warman O'Brien, our mission is to support pioneering biotech and pharma companies by connecting them with the brightest minds, thereby fuelling future clinical trials globally.
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Such an important issue — and one that still doesn’t get enough attention. The underrepresentation of Black people in clinical trials is well documented, but the situation is even more alarming for Black women. Despite having a higher incidence of aggressive breast cancers, such as triple-negative breast cancer (TNBC), Black women are consistently underrepresented in clinical research. My recent white paper explores the historical exploitation of Black communities in clinical research, including the legacy of unethical trials like the Tuskegee Syphilis Study and the case of Henrietta Lacks. This history has left a deep mistrust in the medical system — which directly impacts clinical trial participation today. If we want truly equitable healthcare outcomes, we need to address this imbalance head-on. That means improving diversity in trial enrollment and rebuilding trust through transparency, engagement, and culturally competent care. 👉 If you'd like to learn more about the historical context and steps toward improving diversity in trials, feel free to DM me or email cornnelia@cetacea.ch — I'd be happy to share the white paper with you!