Supporting Women’s health: Addressing gender disparities in clinical trials 
June 24, 2022

The history of women’s health in clinical trials: why there's a gender gap

According to the Nation Institute of Health’s Office of Research on Women’s Health, in 1977 the FDA recommended the exclusion of pregnant women and women of ‘childbearing potential’, regardless of contraception, from Phase I and Phase II clinical trials. This ensued after incidents occurred in Canada and throughout the EU of children being born with physical deformities as a result of pregnant women who had taken drugs with little known research on the effects.  

This recommendation perpetuated a preexisting gender gap in clinical trial demographics in the United States which limited the study and understanding of drug interactions and therapeutics to male participants. This inevitably led to an extreme shortage of data on women’s health as it related to new forms of therapies and drug treatments leaving large question marks in women’s health as a whole. 

It wasn’t until the NIH Revitalization Act of 1993 that directed the National Institute of Health (NIH) to outline and establish guidance on the inclusion of women in clinical trials. In 1994, a congressional mandate established the Food and Drug Administration's Office of Women’s Health to advocate for the participation and inclusion of women in clinical trials. Which led to one of the first government-directed pushes for women’s inclusion in early trial phases. 

Why is this history important? 

Due to the long-standing exclusion of women, especially those pregnant or of childbearing age, enforced a fear that many if not all clinical trials were unsafe for women to participate in. To this day in 2022, women still face many hesitancies that could have resulted from past stigma and fears.  Pfizer published a list of “possible reasons why women are less likely to be enrolled or to enroll in clinical trials compared with other patient populations. [including:]

  • Lack of understanding of the effects of the disease in women which can lead to under-diagnosing or not referring women to a study.
  • The misperception among study sponsors and investigators that it takes more time and money to recruit women.
  • Fear of harm to an unborn baby if a woman becomes pregnant during the clinical trial.
  • Unintentionally excluding women from participating in a clinical trial due to various study restrictions (e.g., study that excludes people with smaller body surface areas can exclude women patients).
  • Family responsibilities that limit the amount of time a woman is available to participate.”

Women still face the negative consequences of being excluded from health research in the past. This has led to misdiagnoses, incorrect generalizations about women’s health, suboptimal health outcomes, and more according to a women’s health article by Kristin Samuelson, a health writer for Northwestern University’s Feinberg School of Medicine.  

Overcoming these inequities

In 2022, how can we ensure that women are not only appropriately included in clinical trials, but how can we start to mitigate the detriments of the past? For starters, patient recruitment is essential in appropriately diversifying a study’s participant pool while capturing ideal patients. This can be an expensive and time-consuming task if not streamlined properly. Deploying a strategic and mature recruitment tactic with data-driven methods and verified experience is a start. Understanding how to recruit patients can be difficult, but knowing where to find them and how to reach them can add a new level of complexity. 

Being able to identify ideal patients, locate potential participant pools to target, and then reach those potential participants where they are is crucial to recruitment. Furthermore, having the capacity to do this within an expedited timeline optimizing funds for efficiency without compromising the effectiveness of recruitment ads can be the difference between a successful recruitment and an expensive loss. 

In a previous women’s health study, Curebase was able to prescreen over 3,300 patients and recruited 400 female participants in 4 months’ time. This was made possible through the activation of 9 local community-directed primary care clinics and the employment of data-back digital recruitment methods by Curebase. By making recruitment frictionless and accounting for specific participant hesitancies, Curebase is able to boost participant interest and expedite enrollment.

Curebase’s decentralized recruitment model gives sponsors the reach they need to find patients anywhere and bring their study to meet patients where they are. With complex and proven targeting methods, Curebase has a successful track record of deploying our decentralized model to fast-track recruitment while diversifying participant pools. 

With over 11,000 patients consented on the platform, Curebase reported 32% more diverse populations in their recruited studies than the FDA average. 

Furthermore, in two recent studies (non-women’s health-specific), Curebase recruited majority-female patients: the first 64% female and the second 79% female. Diversifying studies and ensuring women’s participation is a step in the right direction for leveling the inequalities but it doesn’t stop there. 

Facilitating women’s health-specific studies such as pregnancy, STIs, menopausal, and post-menopausal related trials can help bridge the gap in knowledge on female health. As an example, recruiting for and managing trials relating to pregnancy comes with specific challenges that need to be addressed, such as pregnancy complications or questions, assessing patient health on a regular basis to ensure the safety of patients and fetuses, and more. During a study for high-risk pregnant patients, Curebase connected with patients’ preexisting OBGYNs to ensure the proper collection of patients’ medical history, pregnancy updates, and delivery notes. Curebase also utilized automated check-in points with patients to ensure their well-being leading up to and after giving birth. 

Want to subscribe to our blog?
  • Invisible 1
  • Invisible 2
  • Invisible 3

NEWS: Curebase closes $40M Series B with strategic investment by Gilead. Read about it in TechCrunch, Fierce Biotech, andEndpoints News.

Supporting Women’s health: Addressing gender disparities in clinical trials 

June 24, 2022

Women still face the negative consequences of being excluded from health research. How can we ensure that women are not only included in clinical trials but start to mitigate the detriments of the past?

The history of women’s health in clinical trials: why there's a gender gap

According to the Nation Institute of Health’s Office of Research on Women’s Health, in 1977 the FDA recommended the exclusion of pregnant women and women of ‘childbearing potential’, regardless of contraception, from Phase I and Phase II clinical trials. This ensued after incidents occurred in Canada and throughout the EU of children being born with physical deformities as a result of pregnant women who had taken drugs with little known research on the effects.  

This recommendation perpetuated a preexisting gender gap in clinical trial demographics in the United States which limited the study and understanding of drug interactions and therapeutics to male participants. This inevitably led to an extreme shortage of data on women’s health as it related to new forms of therapies and drug treatments leaving large question marks in women’s health as a whole. 

It wasn’t until the NIH Revitalization Act of 1993 that directed the National Institute of Health (NIH) to outline and establish guidance on the inclusion of women in clinical trials. In 1994, a congressional mandate established the Food and Drug Administration's Office of Women’s Health to advocate for the participation and inclusion of women in clinical trials. Which led to one of the first government-directed pushes for women’s inclusion in early trial phases. 

Why is this history important? 

Due to the long-standing exclusion of women, especially those pregnant or of childbearing age, enforced a fear that many if not all clinical trials were unsafe for women to participate in. To this day in 2022, women still face many hesitancies that could have resulted from past stigma and fears.  Pfizer published a list of “possible reasons why women are less likely to be enrolled or to enroll in clinical trials compared with other patient populations. [including:]

  • Lack of understanding of the effects of the disease in women which can lead to under-diagnosing or not referring women to a study.
  • The misperception among study sponsors and investigators that it takes more time and money to recruit women.
  • Fear of harm to an unborn baby if a woman becomes pregnant during the clinical trial.
  • Unintentionally excluding women from participating in a clinical trial due to various study restrictions (e.g., study that excludes people with smaller body surface areas can exclude women patients).
  • Family responsibilities that limit the amount of time a woman is available to participate.”

Women still face the negative consequences of being excluded from health research in the past. This has led to misdiagnoses, incorrect generalizations about women’s health, suboptimal health outcomes, and more according to a women’s health article by Kristin Samuelson, a health writer for Northwestern University’s Feinberg School of Medicine.  

Overcoming these inequities

In 2022, how can we ensure that women are not only appropriately included in clinical trials, but how can we start to mitigate the detriments of the past? For starters, patient recruitment is essential in appropriately diversifying a study’s participant pool while capturing ideal patients. This can be an expensive and time-consuming task if not streamlined properly. Deploying a strategic and mature recruitment tactic with data-driven methods and verified experience is a start. Understanding how to recruit patients can be difficult, but knowing where to find them and how to reach them can add a new level of complexity. 

Being able to identify ideal patients, locate potential participant pools to target, and then reach those potential participants where they are is crucial to recruitment. Furthermore, having the capacity to do this within an expedited timeline optimizing funds for efficiency without compromising the effectiveness of recruitment ads can be the difference between a successful recruitment and an expensive loss. 

In a previous women’s health study, Curebase was able to prescreen over 3,300 patients and recruited 400 female participants in 4 months’ time. This was made possible through the activation of 9 local community-directed primary care clinics and the employment of data-back digital recruitment methods by Curebase. By making recruitment frictionless and accounting for specific participant hesitancies, Curebase is able to boost participant interest and expedite enrollment.

Curebase’s decentralized recruitment model gives sponsors the reach they need to find patients anywhere and bring their study to meet patients where they are. With complex and proven targeting methods, Curebase has a successful track record of deploying our decentralized model to fast-track recruitment while diversifying participant pools. 

With over 11,000 patients consented on the platform, Curebase reported 32% more diverse populations in their recruited studies than the FDA average. 

Furthermore, in two recent studies (non-women’s health-specific), Curebase recruited majority-female patients: the first 64% female and the second 79% female. Diversifying studies and ensuring women’s participation is a step in the right direction for leveling the inequalities but it doesn’t stop there. 

Facilitating women’s health-specific studies such as pregnancy, STIs, menopausal, and post-menopausal related trials can help bridge the gap in knowledge on female health. As an example, recruiting for and managing trials relating to pregnancy comes with specific challenges that need to be addressed, such as pregnancy complications or questions, assessing patient health on a regular basis to ensure the safety of patients and fetuses, and more. During a study for high-risk pregnant patients, Curebase connected with patients’ preexisting OBGYNs to ensure the proper collection of patients’ medical history, pregnancy updates, and delivery notes. Curebase also utilized automated check-in points with patients to ensure their well-being leading up to and after giving birth. 

More articles from our blog:
Curebase welcomes
Adam Samson as director of clinical operations
June 18, 2020

At Curebase we are rapidly expanding and preparing for the wave of decentralization in clinical trials that we intend to lead. To that end we have recently hired a Director of Clinical Operations, Adam Samson...

Read more
Supporting Women’s health: Addressing gender disparities in clinical trials 
June 24, 2022

Women still face the negative consequences of being excluded from health research. How can we ensure that women are not only included in clinical trials but start to mitigate the detriments of the past?

How decentralized clinical trial models and technology can address common CNS study challenges
May 25, 2022

As the FDA continues to push patient-centricity, careful considerations when planning, building, and executing a CNS trial are ever-growing.

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Subscribe to our blog

Get our most recent blogs, whitepapers, webinars and case studies delivered straight to your inbox.

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
335 S Van Ness Ave, San Francisco, CA,
94103-3627, United States