Gender and R&D: DNDi effectively mobilized

Viewpoint by Joelle Tanguy, Director of External Affairs, DNDi

‘No one should be excluded from access to effective medicines and diagnostics. In order to see real change, we must advocate for shifts that promote the inclusion of women in clinical studies safely, and as early as possible,’ wrote Bernard Pécoul, DNDi Executive Director, together with David Reddy, Mel Spigelman, and Catharina Boehme in March 2020, illustrating the potential of their product development partnerships to drive change in a reluctant global R&D ecosystem.^[i]

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.

About the author: Joelle Tanguy is DNDi’s Director of External Affairs and former Director of Strategic Partnership and Advocacy at UN WOMEN.

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