Designing What Works: A Women’s History Month Reflection on Leadership in Clinical Research

Women’s History Month always makes me pause.

It’s a time to reflect on progress. The doors opened, the barriers challenged, the milestones achieved. But for me, it’s also a time to think about something just as important: who is shaping what comes next.

Last week, we premiered the first conversation in our Trial & Error series, “Designing Clinical Trials that Work.” As I sat in that conversation, I found myself reflecting on something I see every day in this work.

Clinical research does not fall short because people do not care. It falls short because it has not always been designed with real people in mind. How we live. What we need. What we carry. And what ultimately influences whether we choose to participate or not.

What made that conversation meaningful to me was not only the topic. It was who was shaping it.

There was a clarity in the room. A shared understanding that the gap between research and community is not simply about awareness or access. It is about design. And design shapes everything. It influences who feels seen, who feels considered, and who ultimately decides to engage.

For too long, women, especially women from underrepresented communities, have been brought into research conversations too late or positioned only as participants rather than contributors. I have seen that firsthand. I have also seen what happens when that begins to shift.

More women are stepping into roles that influence how research is structured from the beginning. They are advising on study design, shaping participant experience, identifying real-world barriers, and helping define how research is communicated in ways that actually resonate.

This is not just about representation. It is about influence. It is about intention.

At the same time, we have to be honest about where we still fall short.

While women are represented in many clinical trials today, that representation is not consistent across all conditions, populations, or stages of research. And beyond participation, there is still a noticeable gap in who is influencing research as advisors, consultants, and decision-makers. This is especially true for women of color, whose perspectives are critical to ensuring research reflects the realities of the communities most impacted.

According to the U.S. Food and Drug Administration and the National Institutes of Health, progress has been made in inclusion, but gaps remain in how women are represented in research design, enrollment, and analysis.

That reality is not just about numbers. It reflects how research has been designed, who it has been designed for, and what barriers still exist in practice. Participation is often framed as a question of willingness. In reality, it is often a reflection of whether research feels relevant, accessible, and responsive to the realities of people’s lives.

And that is where this conversation becomes more urgent.

Because if we are serious about improving outcomes, we cannot only focus on who is participating. We also have to focus on who is shaping the work.

One of the most powerful elements of this Trial & Error conversation, for me, was the recognition that expertise does not only come from credentials. It comes from lived experience, proximity to the communities we aim to serve, and a deeper understanding of how people move through healthcare systems in real life.

When that perspective is missing, research may be scientifically sound but disconnected. When it is present, research becomes more responsive, more relevant, and ultimately more effective.

This is where I see women’s leadership showing up in ways that are both powerful and, at times, underrecognized. It shows up in the questions being asked, in the assumptions being challenged, and in the insistence that research reflect the realities of the people it is meant to serve.

I want to take a moment to acknowledge the women who are contributing to this work at PEP!IN in advisorship, partnership, and across the industry. Martha Dockery, M.S., Melva T. Covington, MBA, MPH, PhD, and Cheryl Beal Anderson, PharmD, MBA, Roxana Malene, Dr. Seanna Thompson, and Katya Solovyeva, PhD, who each bring a level of insight, rigor, and commitment that continues to push this work forward in meaningful ways.

Their perspectives do not simply add to the conversation. They deepen it. They challenge it. And they help ensure that what we are building is grounded, thoughtful, and reflective of the communities we serve.

As a co-founder of PEP!IN, I am constantly reminded that this work is not built in isolation. It is built in conversation. In collaboration. In moments where different perspectives push me to think more deeply and design more intentionally.

It is also built through relationships and trust, which cannot be rushed and cannot be replicated without real presence.

The Trial & Error series reflects something I believe many of us know. Progress in this space often comes through iteration. But what is becoming increasingly clear to me is that we do not have to rely on trial and error in the same way when we are willing to bring the right voices into the process earlier.

When we design with intention, informed by both expertise and lived experience, we begin to move beyond reactive solutions and toward systems that work more effectively from the start.

And that is also where opportunity exists.

For sponsors, CROs, healthcare organizations, and partners, this is not just a reflection. It is an invitation.

An invitation to think differently about who you engage.

An invitation to expand who is in the room when decisions are being made.

An invitation to move beyond performative inclusion and toward meaningful collaboration.

Because the question is no longer just, “How do we increase participation?”

The question is, “Who are we trusting to help design what participation looks like?”

As someone who is not the traditional I believe deeply that better research begins with better design. And better design begins with who is at the table, how early they are brought in, and whether their voices carry real influence.

Women are not just part of that future. We are helping to define it.

This Women’s History Month, I am not only reflecting on what has been accomplished. I am thinking about the women who are actively building what comes next, often without recognition, but with impact that is undeniable.

If you were not able to join us for Trial & Error: Designing Clinical Trials that Work, the conversation is now available to watch and listen to on demand.

I encourage you not only to watch, but to consider where you and your organization sit in this evolution. Because the future of research will not be defined by intention alone. It will be defined by who we choose to engage, and how early we choose to listen.

Because when we design with intention, we move closer to research that actually works.

References

• U.S. Food and Drug Administration (FDA). Enhancing the Diversity of Clinical Trial Populations.

  
  

  Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs | FDA

  
  

• National Institutes of Health (NIH). Inclusion of Women and Minorities in Clinical Research.

  
  

  https://grants.nih.gov/policy/inclusion/women-and-minorities.htm