A persistent knowledge gap in clinical trials makes it difficult to understand whether medicines act differently in men and women. The knowledge gap is even wider when it comes to pregnant and lactating women, and women of childbearing age because of the potential risk of exposing the foetus to investigational drugs.
Meanwhile, women and girls are disproportionately affected by neglected tropical diseases (NTDs) and yet have less access to medical care. For example, there are disparities in care for women in contexts where their caretaking role undermines their ability to get timely diagnosis and access to treatment, and this especially affects poor, rural women. Special gender considerations are therefore needed in ensuring equitable access to clinical trials and access to treatment.
Clinical research practice has been slow to proactively address the significant variables contributing to differences in health outcomes between women and men, and even slower to understand the many gender dimensions resulting in neglect and broader issues of diversity and social identity, including class, geography, ethnicity/race, age, sexual orientation, and (dis)ability. Yet, it is effectively the intersection of these factors that defines the geography of neglect.
Let’s consider the intersection of sex, age, and societal expectation on young women. Female patients, sometimes very young, who have reached menarche and could become pregnant during treatment or during a clinical study are often excluded from clinical trials. One mitigating precaution for this group is to require the use of long-acting, reversible contraception; however, contraceptives are not always widely available, culturally acceptable, adhered to, or effective in preventing pregnancy.
Since they are seldom considered a specific population in scientific literature concerning clinical research and development, there are no guidelines for this population. Yet, there is an ethical need for appropriate data on new treatments for any population before regulatory approval.
Based on DNDi’s experience across four continents, Nathalie Strub-Wourgaft, DNDi Neglected Tropical Diseases Director, together with colleagues Monique Couderc-Pétry, Elisabeth Eléfant, Monique Wasunna, Alwyn Mwinga, and Nilima A. Kshirsaga, published a proposal for a safe ethical framework for the recruitment of women susceptible to and becoming pregnant in clinical trials of new drugs against NTDs to address the ethical need for appropriate data on new treatments before regulatory approval.[ii]
This exemplifies what DNDi can do: not only proactively factor gender in the design of its clinical trials and access programmes, but also contribute to advancing knowledge in this field and promoting a more progressive agenda.
DNDi is committed to championing gender-responsive practices in global health research and development:
- Designing responsible clinical research strategies to model and contribute to best practices in gender-responsive drug development, including by promoting the inclusion of women, especially women of childbearing age, and by systematically providing disaggregated clinical trial results
- Applying a gender and intersectionality lens to access strategies by acknowledging connections between gender, vulnerability, disadvantage, and health
- Exploring, documenting, and publishing our findings to inform our disease strategies and demonstrating the potential for change through a wider movement
- Promoting the participation and empowerment of women and young women in science throughout our partnerships and collaborations
About the author: Joelle Tanguy is DNDi’s Director of External Affairs and former Director of Strategic Partnership and Advocacy at UN WOMEN.
Photo credit: Anita Khemka-DNDi
[i] Closing the gender gap in medical research. Global Cause, 8 March 2020. www.globalcause.co.uk/women-and-girls/closing-the-gender-gap-in-medical-research/
[ii] Inclusion of women susceptible to and becoming pregnant in preregistration clinical trials in low- and middle-income countries: A proposal for neglected tropical diseases by Couderc-Pétry M, Eléfant E, Wasunna M, Mwinga A, Kshirsagar NA, Strub-Wourgaft N. PLOS Neglected Tropical Diseases, June 2020, 14(6): e0008140. doi: 10.1371/journal.pntd.0008140.
