Evaluating a New Market: Clinical Trial Diversity Recruitment Through Culturally-Tailored Engagement

Context

By 2023, SameSky Health had proven its culturally-tailored engagement model in the health plan market, reaching 2.8 million members across 15 states with measurable lifts in HEDIS quality scores and Annual Wellness Visit completion. The question facing the product team was whether the same capabilities that made us effective at reaching underserved health plan members (multilingual outreach, cultural tailoring, behavioral engagement, community-based trust) could create value in adjacent markets.

Clinical trial diversity recruitment was a natural candidate. The industry had a well-documented problem: clinical trials in the US consistently under-represent minority populations. This isn't just a health equity issue; it's a scientific validity issue. Drugs and treatments are approved based on data that doesn't reflect the full population of people who will actually use them. The most under-represented populations are the elderly, women of child-bearing age, and ethnic minorities. The FDA has increasingly pressured sponsors to improve diversity in trial enrollment, and several large pharmaceutical companies had begun investing in diversity recruitment solutions. However, most of those solutions were technology-first approaches that didn't address the deeper structural barriers.

I was asked to help evaluate whether SameSky should enter this market and, if so, where we had a differentiated ability to win.

The Real Question

The surface question was "should we build a clinical trial recruitment product?" But the real question was more nuanced: at which points in the clinical trial patient journey could our specific capabilities create value that existing solutions could not?

Clinical trial participation isn't a single moment. It's a journey with at least four distinct stages, each with its own barriers:

Most diversity recruitment solutions focused on the first stage (finding patients). Very few addressed why diverse patients drop out of the process at every subsequent stage. Dropouts get most costly at each progressive stage due to losing the sunk cost and time.

The Strategic Analysis

Working Backwards: Starting from the Patient

Amazon's Working Backwards methodology frames the opportunity from the patient's perspective before evaluating business viability. Step 1 is writing a press release for the product we would build, describing the benefit to the end user (the patient), not the buyer (the trial sponsor).

This exercise immediately clarified that the most impactful intervention wasn't recruitment. It was everything that happened after recruitment: the informed consent experience, the logistical barriers to participation, and the support infrastructure during the trial. Part of the solution is finding new ways to ask patients to participate, but the market was actually full of solutions for that problem as it has heavy overlap with the advertising and personalized marketing space. Diverse patients don't fail to enroll because nobody asked them. They fail to enroll because the process is inaccessible, the trust isn't there, and the support system assumes a patient profile that doesn't match their reality.

7 Powers: Where Could SameSky Win?

Applying Hamilton Helmer's 7 Powers framework helped evaluate whether SameSky had a defensible competitive advantage in this market:

The analysis confirmed that SameSky had a defensible position (assuming the joint entry with our proposed partner), but only if we entered at the right point in the patient journey.

Strategyzer Business Model Canvas and Innovation Tools

I used the Strategyzer Business Model Canvas to map the full business model for each of the four product concepts I was evaluating. This included value proposition design, customer segment analysis, channel strategy, revenue model, key partnerships, and cost structure. I also used Strategyzer's Value Proposition Canvas to ensure that each concept addressed a real job-to-be-done for the patient (not just the trial sponsor) and mapped the gains and pains specific to underserved populations.

The Four Product Concepts

The analysis produced four distinct intervention concepts, each mapped to a stage of the patient journey:

The Recommendation

My analysis concluded that SameSky could not have much of a positive impact on Phase 1 and 2 clinical trials. Those trials are small, tightly controlled, often require extended inpatient stays, and operate within specialized clinical environments where our engagement model added limited value. These early-stage trials are often considered unsafe for the more vulnerable members of the population such as the elderly and women of child-bearing age, as the risks are just too high.

Phase 3 and 4 trials were a different story. These are large-scale protocols, often outpatient, with thousands of participants needed and retention rates that directly determine whether the trial succeeds or fails. They've already passed a minimum safety threshold and sometimes even already have approvals to be marketed to the general population. Our capabilities in culturally-tailored outreach, community-based trust building, logistical support coordination, and behavioral engagement mapped directly to the barriers that cause diverse participants to drop out of these larger trials.

We were exploring a co-entry strategy with the innovation arm of a Fortune 10 healthcare company that had both the clinical trial sponsor relationships and the operational infrastructure to complement SameSky's engagement capabilities. We developed the joint go-to-market framework, but the partner ultimately decided not to proceed. SameSky would likely have moved forward based on my recommendations otherwise.

What I Learned as a Participant

As part of this initiative, I wanted to experience the clinical trial process firsthand. I signed up through the NIH Healthy Volunteers website and have since completed multiple clinical trial and research protocols at the National Institutes of Health.

This wasn't academic research. I went through the full patient experience: the recruitment and screening process, reading and signing informed consent documents, adhering to visit schedules and specimen collection protocols, interacting with research coordinators and clinical staff, and completing post-study follow-up. I experienced firsthand the friction points, communication gaps, and moments of confusion that our market research had identified from the outside.

My NIH research team regularly invites me back and has told me I'm one of their favorite participants because I provide detailed, constructive feedback on the patient experience of each study and offer ideas for improvement. This is essentially ongoing, self-directed user research in the clinical trials space. Every protocol I participate in deepens my understanding of where the process works, where it breaks down, and what a thoughtful product team could do about it.

What I Would Do Differently

I would have pushed harder to pursue the opportunity independently when the partner decided not to proceed. The market analysis was sound, the competitive positioning was strong, and the intervention points were clearly mapped. The partner's decision was driven by their own strategic priorities, not by a flaw in our business case. If I had framed the partnership as one possible channel rather than a prerequisite for market entry, we might have found an alternative path forward with a different channel partner.

I would also have started the NIH participation earlier. The firsthand experience transformed my understanding of the clinical trial patient journey in ways that no amount of secondary research could replicate. Beginning that immersion at the start of the market evaluation rather than midway through would have produced sharper insights from the beginning.