Nav: Home

Sex, gender, or both in medical research

November 22, 2016

No one can deny that men and women have different genes, biology and anatomical features. However, only a minority of medical studies take this into account when analyzing and reporting research results. Time to hold researchers accountable, argue two leading experts on sex and gender, not just for the sake of equity, but mainly for the sake of health.

Dr. Cara Tannenbaum, a professor in the Faculty of Medicine at the University of Montreal and Scientific Director of the Institute of Gender and Health (Canadian Institutes of Health Research), and Dr. Janine Austin Clayton, Director of the Office of Research on Women's Health at the National Institutes of Health (USA), have written a Viewpoint article that has just been published in the Journal of the American Medical Association (JAMA), outlining a compelling rationale and new reporting standards for stratifying research data by sex, gender or both.

"Until recently, most human health research has favoured men, despite the fact that women comprise half the population," said Dr.Tannenbaum.

To remedy the situation, the Sex and Gender Equity in Research (SAGER) guidelines were recently posted on the EQUATOR website, an international network providing medical research guidelines worldwide. "Scientific journal editors are in a unique position to improve sex and gender reporting in health-related research" said Dr. Tannenbaum. It's time to hold scientists accountable. "

Sex is not gender

The terms "sex" and "gender," and what they really mean, continue to confuse scientists and the general public. "We want to put the record straight," affirms Tannenbaum. "A person's sex refers to their biology, i.e., their XX or XY chromosomes, their anatomy, and their sex hormones."

Gender, however, is more complex. It encompasses social, behavioural, and cultural interactions, diverse expressions of identity, and the roles and power relations between men and women in society. "Gender is equally or more important than sex when it comes to a person's physical and mental health," said Tannenbaum. A research group from Canada, led by Dr. Louise Pilote, recently showed that gender, more than sex, predicts poor outcomes after an early heart attack.

Missing information- The results of clinical trials are not always reported for men and women separately "Too often, sex- and gender-specific results are missing from publications on medical research, particularly those evaluating therapies," said Dr. Tannenbaum. She explained that scientists who were trained in the 80s or 90s learned to conduct research only in men, believing the results were translatable to women.

"But we now know that women metabolize certain drugs differently than men do," she added. "By not studying women or by reporting only combined results, we could be missing information critical for women's health. Sick women become pregnant and pregnant women become sick and need medicine. By excluding women from research, it prevents doctors from knowing how to treat women in our society safely."

As noted in the article, many journals, including JAMA, are now requiring greater transparency and scientific rigor through the inclusion of sex/gender information. If investigators study only one sex/gender, they are increasingly being required to explain why that is, except for studies on sex-specific diseases like ovarian and prostate cancers.

The article outlines three important reasons to stratify and report data by sex, gender, or both:
  • To see sex/gender-specific results that might otherwise be hidden by combined results.
  • To provide robust raw data for meta-analyses, a sophisticated statistical technique for combining the results from many studies to see if the magnitude of an effect is consistently the same or different across diverse populations of men and women.
  • To avoid the need to repeat a trial to check for sex/gender-specific matters that might arise late in the investigative process.

Should women's drug doses be the same as men's?

"The fact that regulatory agencies like the Food and Drug Administration (USA) and Health Canada are now issuing warnings that certain drugs, such as the sedative zolpidem, should be prescribed to women at half the dose is a signal that we have to take our duty more seriously protect women's health," noted the researcher.

In the case of the sleeping pill zolpidem, some women end up with high levels of drugs still in their bloodstream, which can affect their ability to drive or perform other tasks involving memory, concentration, and coordination.

When drugs for women are tested on men

In addition, men are still the most frequent subjects of clinical trials, even for drugs for women. Take the example of Addyi, the first drug to boost sexual desire in women. It was tested in twenty-three men and two women to determine what happens when it is taken with alcohol. The study found that mixing Addyl with alcohol increased the risk of fainting, dizziness, and low blood pressure. Thus, the risk is probably greater for women, who are more sensitive to alcohol.

When will medical research be 50/50?

The recently published Sex and Gender Equity in Research (SAGER) guidelines for the inclusion of sex and gender information in studies urge journals to adopt the new standards to elevate the rigor and relevance of publications. Several journals have already adopted the guidelines. The pressure is growing from an ethical and scientific standpoint to fund research that will inform personalized health care according to an individual's genes, sex, gender, age, ethnicity, race and lifestyle risk factors.

"It is both good science and the right thing to do," said Dr. Tannenbaum
Article Citation:

Clayton JA, Tannenbaum C. Reporting Sex, Gender, or Both in Clinical Research? JAMA. 2016;316(18):1863-1864. doi:10.1001/jama.2016.16405.

SAGER Guidelines:

University of Montreal

Related Clinical Trials Articles:

Giving children a voice in clinical trials
Children as young as 8 years old with incurable cancer can reliably characterize the impact an experimental therapy has on their symptoms and quality of life -- even at the earliest stages of drug development -- making self-reported patient outcomes a potential new clinical trial endpoint.
Better health for women involved in clinical trials
Women who participate in obstetric and gynecology clinical trials experience improved health outcomes compared to those who are not involved in trials, according to research by Queen Mary University of London.
Final artificial pancreas clinical trials now open
Clinical trials are now enrolling to provide the final tests for a University of Virginia-developed artificial pancreas to automatically monitor and regulate blood-sugar levels in people with type 1 diabetes.
Why the bar needs to be raised for human clinical trials
Standards for authorizing first-time trials of drugs in humans are lax, and should be strengthened in several ways, McGill University researchers argue in a paper published today in Nature.
New drug formulary will help expedite use of agents in clinical trials
The National Cancer Institute (NCI) today launched a new drug formulary (the 'NCI Formulary') that will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials.
Review examines diversity in dermatology clinical trials
Racial and ethnic groups can be underrepresented in medical research.
Reshaping the future of global clinical trials practice
Researchers at the University of Liverpool have developed a new international guideline to help standardize how results from clinical trial studies are reported.
Fewer cardiovascular drugs being studied in clinical trials
The number of cardiovascular drugs in the research pipeline has declined across all phases of development in the last 20 years even as cardiovascular disease has become the No.
Sex hormones skew outcomes in clinical trials -- here's how
Clinical research often excludes females from their trials under the assumption that 'one size fits all,' that a painkiller or antidepressant will be equally effective in subjects of either sex, but a growing number of scientists are criticizing this approach.
Nearly half of pediatric clinical trials go unfinished or unpublished
Clinical trials in children commonly go either uncompleted or unpublished, finds a comprehensive study conducted by researchers at Boston Children's Hospital.

Related Clinical Trials Reading:

Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines
by Tom Brody PhD (Author)

Fundamentals of Clinical Trials
by Lawrence M. Friedman (Author), Curt D. Furberg (Author), David L. DeMets (Author), David M. Reboussin (Author), Christopher B. Granger (Author)

Clinical Trials: A Methodologic Perspective (Wiley Series in Probability and Statistics)
by Steven Piantadosi (Author)

A Clinical Trials Manual From The Duke Clinical Research Institute: Lessons from a Horse Named Jim
by Margaret Liu (Author), Kate Davis (Author)

A Concise Guide to Clinical Trials
by J. Rick Turner PhD (Author)

Oncology Clinical Trials: Successful Design, Conduct, and Analysis
by William Kevin Kelly DO (Editor), Susan Halabi PhD (Editor)

A Practical Guide to Managing Clinical Trials
by JoAnn Pfeiffer (Author), Cris Wells (Author)

An Overview of Clinical Trial Operation: Fundamentals of clinical trial planning and management in drug development
by Biswal and Jose (Author), Shibadas Biswal (Author), Vinu M Jose (Author)

Introduction to Statistical Methods for Clinical Trials (Chapman & Hall/CRC Texts in Statistical Science)
by Thomas D. Cook (Editor), David L. DeMets (Editor)

Statistical Design and Analysis of Clinical Trials: Principles and Methods (Chapman & Hall/CRC Biostatistics Series)
by Weichung Joe Shih (Author), Joseph Aisner (Author)

Best Science Podcasts 2018

We have hand picked the best science podcasts for 2018. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Hacking The Law
We have a vision of justice as blind, impartial, and fair — but in reality, the law often fails those who need it most. This hour, TED speakers explore radical ways to change the legal system. Guests include lawyer and social justice advocate Robin Steinberg, animal rights lawyer Steven Wise, political activist Brett Hennig, and lawyer and social entrepreneur Vivek Maru.
Now Playing: Science for the People

#496 Anti-Intellectualism: Down With the Scientist!
This week we get to the bottom of anti-intellectualism. We'll be speaking with David Robson, senior journalist at BBC Future, about misology -- the hatred of reason and argument -- and how it may be connected to distrust of intellectuals. Then we'll speak with Bruno Takahashi, associate professor of environmental journalism and communication at Michigan State University, about how the way we consume media affects our scientific knowledge and how we feel about scientists and the press.