Author: Param Singh
Commentary on a Fireside Chat with Harsha Rajasimha, PhD, CEO & Founder, Jeeva Clinical Trials and Professor Stan Kachnowski, PhD MPA CSEP from HITLAB
For decades, women — particularly women of childbearing potential — were often excluded from early-phase clinical research, leaving major gaps in our understanding of how drugs and devices affect women. While the NIH Revitalization Act of 1993 marked a major turning point, representation and sex-specific analysis still remain uneven across therapeutic areas. [1]
One analysis of high-impact clinical trial publications found that female participants represented 44.6% of enrollment, despite women representing roughly half of the population (Chhaya et al., 2023).
In a recent fireside chat at HITLAB’s Digital Health Symposium, Jeeva’s CEO and Founder, Harsha Rajasimha, PhD, sat down with Professor Stan Kachnowski, PhD MPA CSEP from HITLAB and explored why this gap persists and what it will take to finally close it.
His central argument is both clear and compelling: the barriers to women’s inclusion in clinical trials fall into three categories: Regulation, Protocol Design, and Technology.
Three Barriers, Uneven Progress
Regulation was historically the primary obstacle. The FDA’s 1977 guidelines effectively barred women of childbearing potential from early-phase trials, a policy born from the thalidomide tragedy of the 1950s and 1960s. That exclusion lasted until 1993, when the NIH Revitalization Act and revised FDA guidance reversed course.
Since then, regulatory progress has been substantial: the FDA now requires Diversity Action Plans from sponsors, actively encourages the inclusion of women with childbearing potential in Phase 1 and early Phase 2 studies, and mandates sex-based analysis of outcomes in NIH-funded Phase III trials. Regulation, once the dominant bottleneck, now accounts for a relatively modest share of the overall problem. [2]
Protocol Design is the second barrier, and the one most widely discussed today. Restrictive eligibility criteria, burdensome visit schedules, contraception requirements, endpoints misaligned with women-specific outcomes. These design choices, often made without malice, embed exclusion into the very structure of a trial.
A woman managing endometriosis, caring for children, or navigating menopause-related symptoms may be technically eligible for a study, yet find participation incompatible with her daily life.
The good news is that the industry is increasingly recognizing this. Patient-centric design principles, adaptive protocols, and inclusive eligibility frameworks are gaining traction, if slowly.
Technology and Infrastructure is the third barrier, and the one Dr. Rajasimha believes holds the greatest untapped potential for change. This is not simply about whether a trial uses electronic data capture or has an app.
It’s about the fundamental digital infrastructure that determines how patients interact with research, how data flows between stakeholders, and whether the operational machinery of a trial can accommodate the complexity of real women’s lives.
The Technology Gap No One Is Talking About
“The clinical trial ecosystem still runs on fragmented, disconnected systems requiring human glue to tie them into functional ICH-GCP workflows,” Dr. Rajasimha explained during the fireside chat. “Multiple tools that don’t talk to each other, manual workflows, significant delays in getting therapies to patients. And these inefficiencies disproportionately impact underrepresented populations, especially women.”
Consider what this fragmentation means in practice. A woman participating in a longitudinal study for a condition like Polycystic Ovary Syndrome (PCOS) [3] or an autoimmune disorder may need to report symptoms that fluctuate with hormonal cycles, track behavioral patterns over months, and interact with multiple care teams across different platforms.
In a traditional, site-centric trial model, this means repeated in-person visits, often at locations that aren’t convenient, using systems that capture only episodic snapshots of a condition that is inherently continuous.
The result is twofold: women face participation barriers that reduce enrollment and retention, and the data collected is incomplete, failing to capture the nuances that matter most for women’s health conditions.
It’s a problem of access and intelligence, as Dr. Rajasimha frames it.
A Unified Infrastructure Changes Everything
This is the gap Jeeva was built to close. Rather than layering yet another point solution on top of an already fragmented stack, Jeeva provides a unified digital infrastructure for clinical trials.
One that connects clinical data, patient-reported outcomes, and operational workflows in a single, coherent platform.
What does this mean for women’s inclusion specifically? It means decentralized and hybrid trial capabilities that allow participation from home through eConsent, electronic patient-reported outcomes, and telehealth.
It means flexible participation models that reduce the burden of travel and time, which is critical for women who are often the primary caregivers in their households. It means multilingual and culturally adaptable interfaces that reach diverse populations.
And it means longitudinal engagement tools that capture real-world data over time, which is especially important for reproductive health, menopause research, and chronic conditions that evolve across a woman’s lifespan.
Perhaps most importantly, it means AI-assisted workflows that don’t just analyze data after the fact, but actively orchestrate trial operations in real time, from protocol design to patient matching to anomaly detection. When the technology can accommodate complexity instead of simplifying it away, trials can finally be designed around patients rather than forcing patients to conform to rigid, outdated models.
Inclusion Is Not Just Recruitment, It’s Infrastructure
One of the most important points Dr. Rajasimha made during the conversation is that inclusion cannot be solved at the recruitment stage. “Inclusion starts at the design stage,” he emphasized. “By enabling sponsors and investigators to design patient-centric protocols, we can proactively improve representation rather than trying to fix it later.”
This reframing matters. The industry has spent years trying to recruit more women into trials that were not designed with their realities in mind. It is the equivalent of inviting someone to a dinner party and then serving food they cannot eat. The invitation is not the problem, the menu is. Technology is what allows us to rewrite that menu: to shift from trial-centric thinking to patient-centric, data-centric thinking that captures the full complexity of women’s health.
The Next Decade: A Window of Opportunity
Looking ahead, Dr. Rajasimha outlined three shifts that will define the next era of clinical research.
First, truly patient-centric trial design, adaptive, personalized study models that reflect real-world behavior.
Second, the integration of multi-modal data, combining clinical data, genomics, digital biomarkers, and real-world evidence to create a holistic understanding of disease.
Third, AI-driven clinical research software operations that actively orchestrate trials from end to end, dramatically reducing timelines and costs.
For women’s health, the stakes are enormous. Better understanding of sex-specific biology, more investment in historically neglected conditions, and the ability to generate evidence that reflects women’s lived experiences. These are not aspirational goals. They are achievable outcomes, if the infrastructure exists to support them.
“If we get this right,” Dr. Rajasimha said, “the next decade could finally close the gap and ensure that women receive the same level of scientific attention, innovation, and therapeutic progress as any other population.”
— — —
Regulation opened the door. Better protocol design is widening it. But technology is the engine that will carry women through. At Jeeva, we believe that building the right digital infrastructure is not just a technical challenge, it is a moral imperative. Because every woman excluded from a clinical trial is a data point lost, a treatment untested, and a life left to chance.
References:
- Office of Research on Women’s Health. (n.d.). History of women’s participation in clinical research. National Institutes of Health.
https://orwh.od.nih.gov/toolkit/recruitment/history#10 - National Institutes of Health. (2001, October). NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research.
https://grants.nih.gov/policy-and-compliance/policy-topics/inclusion/women-and-minorities/guideline - World Health Organization. (2023, June 28). Polycystic ovary syndrome.
https://www.who.int/news-room/fact-sheets/detail/polycystic-ovary-syndrome
Related Podcasts & Interviews
- Women in Clinical Trials, Decentralized Clinical Trials
Pharma Focus Podcast Pharmacy Times · Dr. Harsha Rajasimha · September 2023 - Clinical Trials Disparities
KETA-TV Oklahoma News Report · August 2023
Also Read: AI in Clinical Development: Moving from Promise to Practice
About the Author
Param Singh is the Chief Operating Officer at Jeeva Clinical Trials with more than 25 years of experience in the life sciences industry.
He has advised leadership teams across biotechnology, pharmaceutical, and medical device sectors on strategic growth, clinical R&D innovation, and operational transformation. His expertise includes digital transformation, data analytics, and scaling high-performing organizations.
He brings a strong track record of driving business excellence across the life sciences landscape.