Females are under-represented as subjects and leaders in health research

The underrepresentation of female subjects in clinical research trials has profound consequences for public health and product development.

Sue Kleiner, Owner

August 11, 2023

4 Min Read

The Women’s Health Initiative (WHI) is the most far-reaching clinical trial of women's health ever undertaken. It was initiated in 1991 by Dr. Bernadine Healy, the first—and only—female head of the National Institutes of Health. Under Dr. Healy’s leadership, NIH established the policy of funding only trials that included both men and women when conditions studied affected both genders.

We are yet to fully see the changes expected from the implementation of the research regulations swept in with the WHI as well as further regulations governing research enacted at the outset of the 21st century. A gap still exists in the inclusion of females in clinical research trials and in our complete understandings of health and disease conditions and treatments.

A systematic review and meta-analysis of randomized controlled trials concluded that women continue to be inadequately represented as research subjects. With an enrollment rate of 41% in the selected study areas of cardiovascular diseases, neoplasms, endocrine system diseases, respiratory tract diseases, bacterial and fungal infections, viral diseases and digestive system diseases, all areas were below 50% representation. Enrollment is even lower in older age groups of women. Only in the study of immune system diseases was enrollment higher.

Why women matter

The underrepresentation of female subjects in clinical research trials has profound consequences. It is difficult to address the risk/benefit profiles of disease treatments when data are lacking. More serious adverse events from drug treatments are consistently reported for females compared to males, and as females age these numbers increase. How can we know the best healthcare practices for females when we only have data on males? It has become abundantly clear that male data cannot substitute for female-centric data at all stages and phases of the lifespan.

With a growing emphasis on a health versus disease paradigm, personal approaches to prevention, fitness and nutrition are clearly understood as a requirement for enhancements in quality of health throughout a lifetime. Yet within sports science and active nutrition research literature, female representation is even more dramatically lacking, and misinformation regarding personal health strategies for females seems to be rising exponentially.

Two separate international audits of female versus male athletes in sports science and sports medicine research came to similar conclusions. When analyzing all participants included in all sports medicine and exercise science journal research studies in general from 2014-2020, only 34% of all study participants were female, and only 6% included female-only designs compared to 31% male-only studies.

In the second audit, all studies conducted on six evidence-based performance supplements, only 23% of total subjects were female and 34% of all studies included at least one female. The six ingredients studied were beta-alanine, caffeine, creatine, glycerol, nitrate/beetroot juice and sodium bicarbonate. Within the specific supplement studies, 0-8% were female-only, while 0-2% were designed to compare sex-based responses. There were 8 times fewer female-specific studies versus exclusively male subject sets.

A lack of research data has allowed Madison Avenue to swoop in and masquerade as fitness gurus and sports nutrition experts for females. The growth of social media influencers not held to account for evidence-based guidance has fostered a misguided sense in the public that the lack of science is irrelevant, or even worse, that science-based guidance is untrustworthy.

Making women count

Female first and last authorship on scientific publications is less than 25%. There is a current movement among academics and researchers to raise the numbers of female scientists as leaders in promoting female-centric research. New guidance for scientific methodologies to support investigations of the entire female lifecycle, including female reproductive biology (rather than despite it), have been published and are becoming required aspects for publication.

Within the food, beverage and nutraceutical industries there is also an awareness that leadership must become more diverse to meet the needs of an increasingly diverse and vocal market. The Women In Nutraceuticals (WIN) association recently presented survey data addressing gender parity in leadership.

According to the 2022 Women in the Workplace report from McKinsey & Co., 1 in 3 C-suite leaders are women and less than one-third of senior leadership are women. Looking at the nutraceutical industry worldwide, just over one-third of the positions are held by women. The smaller the company the more likely they are to be led by women. Diverse companies are better positioned to capture new markets—increasing both performance and profits.

Ultimately, current leaders believe that greater female representation in decision-making roles in industry will drive the impetus toward more female- and male-centric nutrition and health products that better meet the needs of the consumer and raise their bottom lines.

Susan M. Kleiner, PhD, RD, CNS-E, FACN, FISSN, is owner of High Performance Nutrition LLC, a consultancy based in Washington state.

What do women want? Discover the latest nutrition science and formulation tips for prenatals, children's and menopause supplements by downloading the free Natural Products Insider digital magazine here. 

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About the Author(s)

Sue Kleiner

Owner, High Performance Nutrition

Susan M. Kleiner, Ph.D., RD, CNS-E, FACN, FISSN, is owner of High Performance Nutrition LLC, a consulting firm in Mercer Island, Washington. A trailblazer and internationally recognized expert on nutrition for peak performance, Kleiner is a communicator and consultant, educator and coach, co-founder of the International Society of Sports Nutrition (ISSN) and the author of 10 books, including the bestselling books The New Power Eating, The Good Mood Diet, and Powerfood Nutrition.

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