This essay is part of a series exploring what is required for scientific progress to be made in our understanding of women’s health and our ability to treat the conditions that impact the lives of women everywhere. Learn more about why this is necessary and explore the other challenges and topics linked below.
Women’s Health Research 101
What challenges prevent innovation and understanding in women’s health research?
Most conversations I’ve had over the last few months start the same way:
“My interest in women’s health comes from my own health experience.”
For many of us, our interest in understanding, studying, or working in women’s health comes from our own journey. In my case, I was 36 and faced with a condition I had never heard of, yet affects up to 50% of women¹. After spending hours trying to understand what it was, and how it happened to me, I was infuriated by the lack of information available. I promised myself that someday when my career in startups was done, I would return to the challenges in women’s health and help other women find the answers they’re looking for.
Four years later, I had the opportunity to dig in and learn about the challenges that scientists face when studying women’s health conditions. It has been an eye-opening journey and my goal in this series of essays is to share what I have learned so that others may benefit from my research.
The American medical research system is vast and complex. I am not a scientist or a medical expert. I am a tech entrepreneur with experience solving complex problems, a curious mind, and a passion for understanding this space. The views included are my own and I’d love to hear from others to help expand and challenge them so we can all move the process forward.
These are also my reflections at this moment in time. These essays will age and hopefully, significant progress will be made to improve upon the system and the challenges it creates for progress in women’s health.
What is Women’s Health?
For my research, women’s health refers to any condition that uniquely affects humans who have ovaries and uteruses. This includes how the female body works, the universal experience of PMS, pregnancy, and menopause, as well conditions such as infertility, endometriosis, polycystic ovary syndrome (PCOS), uterine fibroids, and others.
Throughout these writings, I will use the terms “women” and “female” broadly in discussing health challenges that fall into this definition. I recognize and appreciate that people of other genders may also experience these and other challenges.
How Research is Conducted in America
When I embarked on this journey, I knew nothing about how scientific or medical research is done. Below is a quick 101 primer that has come from conversations with many generous people and lots of reading.
Scientific research generally splits into three categories. Basic research, translational research, and clinical research.
Basic research is the first phase of research and is focused on understanding how nature works. Basic research scientists “study the core building blocks of life — DNA, cells, proteins, molecules, etc. — to answer fundamental questions about their structures and how they work.”² Basic research is often not condition-specific, although it may be. It is rarely focused on finding a treatment or cure.
Translational research is about finding treatments using the knowledge discovered in basic research. Translational research “bridges the gap between basic and clinical research by bringing together many specialists to refine and advance the application of a discovery.”³
Clinical research takes what is learned in translational research and explores if a treatment is “safe and effective in patients.”⁴ This is done through multiple phases of clinical trials where progress and outcomes are monitored closely.
These phases of research build upon each other and when progress stalls or fails, scientists must return to the beginning. One in ten therapeutics survive clinical trials and prove to be effective and safe. It is then brought to market and made available to patients. Different therapeutics have different paths into the market depending on the patient population they impact and how they will be used.
Women’s Health Challenges
I have looked at each of these phases to understand what unique challenges are faced at every step of the research process. In the next 6 essays, I will explain why women’s health research faces difficult challenges every step of the way.
- Funding: Public and private funding play a crucial role in determining what gets researched. I have explored the challenges researchers face in getting funding generally and in women’s health specifically.
- Data & Biosamples: Scientists rely on data in all phases of their work and face challenges finding data and accessible biosamples required to be competitive for NIH grants, and further their research in women’s health conditions.
- Models — An important building block in scientific research is animal models. For some very simple reasons, there are huge complexities that prevent scientists from having adequate models to study women’s health.
- Clinical Trials — There are well-documented challenges in the clinical trial system that affect women and our understanding of how different therapeutics affect women.
- Insurance Coverage — The system of health care coverage in America is imperfect and this is also true for coverage of women’s health conditions. Not only does it prevent women from getting the treatments they need, but it also prevents novel therapeutics from getting to market.
- Market — Lastly, the market is not welcoming for many women’s health solutions and this makes success for women’s health companies very difficult.
After exploring all the challenges, I also share why we should have hope, where progress is being made, and why I believe that my daughters will live healthier lives as a result.
I hope you find this helpful in your own understanding and explorations. If you have any feedback, input, new information, or questions, please feel free to reach out to me. KarenARubin[at]gmail.com
Next in the series:
More you might enjoy:
Footnotes:
2, 3, 4. https://blog.dana-farber.org/insight/2017/12/basic-clinical-translational-research-whats-difference/
