Transforming clinical trials for women
By Juan Camilo Arjona Ferreira, Head of R&D and Chief Medical Officer
December, 5 2024
Historically, females have been underrepresented in clinical trials, even for diseases and conditions that occur predominately in women.* Systemic changes to how we approach research are helping, such as the National Institutes of Health’s (NIH) legislation passed into law in 1993 mandating the inclusion of women and minority populations in clinical trials.** Over the four-year period between 2016-2019, an average of 41.2 percent of trial participants in the US in an adult cardiovascular, psychiatric, and cancer trials were female.*** However, sex-based gaps still persist between trial populations and the intended users of these therapies based on distributions of diseases in the population.**
Ensuring that clinical trials are reflective of the populations whose unmet needs we are looking to solve is core to Organon’s mission and how we approach research and development – exploring innovative approaches to transform clinical trial practices, enhancing diversity, and prioritizing health equity.
We challenge the status quo in women’s health R&D through:
- Integrating women’s voices into trial design. It starts with putting her needs at the center – we listen to women’s unique experiences and ideas to identify new ways to advance our research and make a meaningful impact in their lives. Listening to women and incorporating their insights into the design of clinical trials is key to more effective and patient-centric research. Our listening workshops with women helped inform the design of a clinical trial and led us to develop an app to ease their participation burdens.
- Using technology to reduce barriers to participation. Through this data-capturing app, we made it possible for women to participate remotely on their personal device. This use of technology removed participation barriers around transportation, childcare, and paid leave and, importantly, reduced participants* time commitment which can be impactful for participants with a chronic condition.
- Appling data insights to reduce racial disparities. To promote research inclusivity and equitable healthcare outcomes, we use data to select clinical trial sites that serve underrepresented patients. This improves accessibility and helps ensure that women from diverse backgrounds have equal opportunities to participate in our research. We also reach out to underserved patient populations to better understand their needs so we can develop culturally relevant practices and materials that address specific barriers to clinical trial participation.
- Using technology to reduce barriers to participation. Through this data-capturing app, we made it possible for women to participate remotely on their personal device. This use of technology removed participation barriers around transportation, childcare, and paid leave and, importantly, reduced participants’ time commitment which can be impactful for participants with a chronic condition.
Although there is still much work ahead to achieve health equity, the tide is turning with greater attention and investment in women’s health. We now have the technology and knowledge we need to transform the health of women. What we must do now is put it into practice.
* Mazure, C.M., Jones, D.P. Twenty years and still counting: including women as participants and studying sex and gender in biomedical research. BMC Women’s Health 15, 94 (2015). https://doi.org/10.1186/s12905-015-0251-9.
** NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research. Nih.gov. https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm. Accessed June 20, 2024.
*** Alexandra Z. Sosinsky, Janet W. Rich-Edwards, Aleta Wiley, Kalifa Wright, Primavera A. Spagnolo, Hadine Joffe, Enrollment of female participants in United States drug and device phase 1–3 clinical trials between 2016 and 2019, Contemporary Clinical Trials, Volume 115, 2022, 106718, ISSN 1551-7144, https://doi.org/10.1016/j.cct.2022.106718.