TORONTO, Oct. 28 /CNW Telbec/ - Women have successfully broken the glass
ceiling in the boardroom, in politics, and on the home front. Is it now time
for women to lobby for equal representation in research trials?
According to the Heart and Stroke Foundation, more than 50 per cent of
deaths caused by heart disease and stroke - the leading cause of death in
Canada - are women.
But that's a fact you would never guess if you looked at the gender
balance in the crucial clinical trials that study cardiovascular disease,
Dr. Wendy Tsang told the Canadian Cardiovascular Congress 2008 co-hosted by
the Heart and Stroke Foundation and the Canadian Cardiovascular Society.
Dr. Tsang reviewed landmark clinical trials between January 1, 1997 and
December 31, 2007 in leading medical journals The Journal of the American
Medical Association (JAMA), The Lancet ,and the New England Journal of
"These are major trials published in the world's leading medical
journals," says Dr. Tsang who is a cardiology resident at the University of
Toronto. "Trials published in these journals undergo rigorous peer and
Dr. Tsang's study found that although women comprise 53 per cent of
patients in the general population with cardiovascular disease, in clinical
trials they represented only 29 per cent of subjects with coronary artery
disease, 25 per cent with congestive heart disease, and 34% with arrhythmias.
Interestingly, they represented 61 per cent of the subjects in prevention
"Our study shows the proportion of women enrolled in landmark
cardiovascular clinical trials is substantially lower than you would find in
the general disease population. What is even more of a shock is that this
under-representation has not drastically changed over the past decade, "says
"This study shows why it's important to put a gender lens on research,"
says Heart and Stroke Foundation spokesperson Dr. Beth Abramson. "Although
women should not get the wrong message - as cardiac care and treatments are
proven in female patients - optimally women should be better represented in
Dr. Abramson adds that in addition to making sure women are well
represented in clinical trials, we need ongoing evaluation into possible
gender differences in cardiovascular disease and how to address them.
The Heart and Stroke Foundation and CIHR's multi-provincial GENESIS
research initiative - which explores the differences in how men and women
experience heart disease - is a good example of how this issue can be
"A trial may show that a drug or therapy benefits patients enrolled in
the trial - but if women are under-represented in the trial, it makes it
difficult to tell if the outcomes of the trial can be applied to women," says
Dr. Tsang. She says that the next step in this research is to figure out what
factors affect female enrollment in clinical trials in order to help address
Addressing this issue may be more difficult than it sounds. In the United
States in the early 1990s the National Institutes of Health put in place a
policy that said there should be a fair representation of women in trials as
long as it was reasonable.
"The results of this study are even more surprising because in 1993 in
the U.S. Congress passed an act to increase enrollment of women and minorities
in trials," says Dr. Tsang. "You would have thought that between then and 2007
there would have been a change. But we didn't find that."
The under-representation of women in clinical trials could be because
they are asked to participate less often than males. Women get heart disease
later in life than men and a lot of trials have an age rule that says nobody
70 or over can enroll. However, Dr. Tsang's research does show women make up
61 per cent of trials that investigate exercise and diet. Could this be due to
That could be next on the research agenda.
To find out more about gender differences in heart disease and stroke
visit heartandstroke.ca or thehearttruth.ca.
Statements and conclusions of study authors are solely those of the study
authors and do not necessarily reflect Foundation or CCS policy or position.
The Heart and Stroke Foundation of Canada and the Canadian Cardiovascular
Society make no representation or warranty as to their accuracy or
The Heart and Stroke Foundation (heartandstroke.ca), a volunteer-based
health charity, leads in eliminating heart disease and stroke and reducing
their impact through the advancement of research and its application, the
promotion of healthy living, and advocacy.
For further information:
For further information: and/or interviews, contact the CCC 2008 Media
Office, (416) 585-3703 (Oct 26-29); Diane Hargrave, Public Relations, (416)
467-9954, email@example.com; Congress information and media registration is
at www.cardiocongress.org; After October 29, 2008, contact: Jane-Diane Fraser,
Heart and Stroke Foundation of Canada, (613) 569-4361 ext 273, firstname.lastname@example.org