HomePharma & BiotechCRORedesigning the Clinical Trial Table: Who’s Missing, Who’s Leading, and What Comes...

Redesigning the Clinical Trial Table: Who’s Missing, Who’s Leading, and What Comes Next

By Maimah Karmo, President, Tigerlily Foundation

In the evolving landscape of clinical trials, the question is no longer “How do we innovate?” It’s “Who are we leaving behind as we do?”

Over the past decade, life sciences and CROs have made notable strides in trial efficiency, biomarker integration, and real-time data capture. But innovation without inclusion is an echo chamber. We may be expanding what’s possible, but for whom?

As a Black breast cancer survivor and an advocate working at the intersection of community, equity, and science, I’ve witnessed firsthand how clinical research has often been shaped by urgency, but not always by empathy. I’ve watched patients navigate fragmented systems, miscommunications, cultural misalignment, and logistical walls that keep trials from being accessible or even visible to the communities that need them most.

And yet, change is happening. Slowly but surely. I see it in life sciences initiatives that center equity from the first protocol draft. I see it in CROs that no longer just ask, “Where can we recruit?” but “How can we build trust long before recruitment begins?” I see it in partnerships that treat patients not as passive participants but as co-creators of the clinical trial experience.

At the same time, with the new administration, we are seeing impacts to health equity that threaten to dismantle years of hard work to build bridges to equity and trust.  We can’t let that happen.  Not only is it not just or right, but it is not humane or good science.  This is where Tigerlily Foundation has stood in the gap for almost 20 years – DEI initiatives or not, we know that good healthcare is about access for all, and today, even more so, with less protection for people at risk, we have to empower individuals to be their own best advocates and continue to collaborate to drive forward solutions in communities in need.

At Tigerlily Foundation, our ANGEL Advocates program is doing just that. We train and elevate young women of color to become the bridge between medical systems and the communities they represent. These advocates aren’t just leading conversations; they’re changing them. From site feasibility to retention strategies, they’re embedding cultural intelligence and lived wisdom into every phase of research design.

But the burden shouldn’t rest on advocates alone. Sponsors, CROs, and life sciences leaders must continue to push the boundary of what “inclusion” really means. It’s not just diverse enrollment. It’s shared power. It’s compensating for community input. It’s building longitudinal trust, not transactional engagement. It’s redesigning consent processes, site selection criteria, and trial logistics to account for real- life childcare, language, transportation, broadband access, and the trauma that too often walks with our patients into the room.

The future of clinical trials will not be won by speed alone. It will be defined by belonging — who we allow to shape the questions, interpret the data, and walk away from the table feeling seen.

We are not just asking for a seat anymore.

We are building the table.

And if you’re in this space  CRO, pharma, biotech  ask yourself this: What are you building? Who are you building it with?  And how are you keeping your commitments and investments to patients and the advocacy groups who serve them?

Maimah Karmo
President
Tigerlily Foundation

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