The underrepresentation of women in medical device clinical trials carries profound implications for the safety and efficacy of medical devices.
Historically, women have been consistently underrepresented in many elements of research, in particularly women from ethnic minority groups. This disparity extends to medical device trials, which are mandatory for evaluating the safety and effectiveness of devices.
Prior to the women’s health movement of the late 1960’s and 1970’s, medical research practices generally ran under the assumption that women were, in essence, considered small men, as coined by Regine Douthard, Senior Medical Officer at the Office of Research on Women’s Health (ORWH) at the NIH. The exclusion of women from clinical trials has persisted for several reasons. For example, historically hormonal variations have been seen as complicating factors, making it challenging to detect treatment effects. Another reason for excluding women from medical trials was safety concerns about the potential impact of medications or medical treatments on women’s reproductive health, particularly during pregnancy. This led to the exclusion of women of childbearing age from trials to avoid any potential risks to developing foetuses and to keep costs down. It was often perceived that additional precautions and monitoring to ensure the safety of female participants could increase trial costs. Additionally, the impact of fluctuating hormones on data analysis was understood to introduce excessive variability and be a drain on resources.
This combination of factors has led to a limited understanding of how medical devices may affect women differently than men, with the consequences being that devices may not be as effective or safe for women, simply because they were not adequately tested on them.
One striking example of the gender gap in medical device trials is in the realm of cardiovascular health. Coronary heart disease is the most common cause of premature death for men and women (British Heart Foundation, 2023). Yet, many medical devices used in the treatment of heart conditions have been primarily tested on male participants. This oversight can lead to suboptimal outcomes for female patients. For instance, stent design and sizing may not account for differences in coronary artery size between men and women, potentially leading to reduced efficacy, stent restenosis (the narrowing of the artery due to the development of scar tissue) and recurrent chest pain. Not to mention, the impact of the subsequent procedures required to correct the problem.
It was as late as 2016 before the United States National Institutes of Health (NIH) rolled out a policy in 2016 called Sex as a Biological Variable (or SABV)*. The policy requires researchers funded by the NIH to include males and females in every experiment unless there is a strong justification not to, such as studies of ovarian cancer. With this in mind, it is clear that medical devices used by women are not guaranteed to have been appropriately tested with females, neglecting the unique physiological factors and needs of female participants. The impact of this negligence means side effects which may disproportionately impact women are not always fully understood.
Finally, clinical trails are sometimes a patient’s only hope of experiencing treatment for a rare condition. Simply put, it is unjust to deny women the opportunity to benefit from medical advancements. Inadequate representation of women in clinical trials can result in unforeseen adverse effects or devices which are less effective or harmful for females. At KD, equality is not just a buzzword; it’s a fundamental requirement for advancing healthcare.
As part of our XXEquals design initiative, we are driven to deliver products and experiences that are tuned to women’s needs, and we have broadened our understanding of the medical device development process to include clinical review submission. For more information on how we can support you please get in touch with Venetia Calcott, venetia.calcott@kinneirdufort.com
References:
*Garcia-Sifuentes Y, Maney DL. Reporting and misreporting of sex differences in the biological sciences. Elife. 2021 Nov 2;10:e70817. doi: 10.7554/eLife.70817. PMID: 34726154; PMCID: PMC8562995.
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