Waterloo Pharmacy PhD candidate, Mira Maximos, investigates sex, gender and the regulation of prescription drugs
Underrepresented populations have been historically excluded from clinical trials including women, racial and ethnic minority groups, and pregnant, lactating, pediatric and geriatric populations. While the importance of including these groups in clinical trials are slowly being recognized and remedied, there are still questions in how currently prescribed drugs affect these populations, including the safety and efficacy of the medications.
“We know that even though we have more policies and regulations suggesting the inclusion of these underrepresented groups, that isn’t always translated to what we see as clinicians and who makes it into clinical trials and there’s a gap between policy and implementation,” says Mira Maximos, PhD candidate in the University of Waterloo’s School of Pharmacy. With how significant the gaps are, the need for informed inclusion of minority groups in research is highly important.
Maximos’ work, in concert with the Centre of Excellence for Women’s Health and Health Canada, is fundamental in theoretical research which highlights where limitations are and how to close these gaps in research. Some of this work created a foundation for Maximos’ current work with her PhD supervisor, JM Gamble, a clinical associate professor in the School of Pharmacy, centering around penicillin allergy risk stratification and de-labelling with consideration for sex and gender.
By understanding how sex and gender impact a drug’s life cycle, clinicians can optimize dosages and monitoring for better therapeutic outcomes. To improve health and gender equity in research and clinical studies, product monograph and consumer information for medications must be transparent to improve and support sex and gender science, and a clear commitment must be made in data transparency and the gaps regarding underrepresented groups and prescription drugs should be recognized to improve regulations.
Read more on Waterloo News.