Lack of Patient Support in Specialty Pharmacy Clinical Trials

The biggest obstacle to clinical trial enrollment often isn’t science or awareness; it’s an unspoken cost nobody in the industry is addressing, Tina Valbh, BSPharm, PhD, managing partner at PharmaKonnect, told a room of specialty pharmacists at NASP’s inSPire2026 conference.

Speaking on a panel exploring specialty pharmacy’s role in clinical research, alongside Jen Lamppa, PhD, SVP of commercial strategy at Inovalon, and Melissa Dragic Swoope, PharmD, CSP, senior director of patient engagement, access, and retention at Lilly, Valbh argued that even a patient who is medically eligible and willing to enroll can still be priced out of participating.

Clinical Trial Recruitment Challenges

Valbh explained that pharmaceutical sponsors typically cover the cost of the investigational product itself, but not the scans, blood work, and travel a trial protocol requires, leaving patients to absorb copays, deductibles, and unreimbursed travel. She pointed to an industry term she’d only recently learned, "financial clearance," in which a patient’s insurer is checked in advance for how much of a trial-related complication, such as a hospitalization from a side effect, it will actually cover.

“If I was a patient, and I had to say I have to pay for the scans, my insurance, or I have to pay for the copays and the deductibles, most patients can’t afford that,” Valbh said. “That is a huge access barrier and a gap that we have to solve. And nobody is talking about that barrier.”

The gap isn’t limited to trial-specific costs, either. Patients enrolled in Medicare Advantage (MA) plans can face prohibitive out-of-pocket expenses just to consult with a trial site, since many MA plans treat those sites as out-of-network, a barrier traditional Medicare doesn’t carry in the same way.¹

Specialty Pharmacy's Place in the Trial Ecosystem

Lamppa framed the discussion around 4 stakeholders navigating clinical trials largely in isolation: patients who don’t know where to find a study, providers who lack full patient data at the point of a treatment decision, sponsors designing protocols without enough real-world input, and payers wanting proof a therapy works across their full member population. She noted that just 8% of trials succeed from phase 1 through approval, roughly 80% are delayed or closed due to recruitment shortfalls, and more than half that fail to enroll enough patients end early. The specialty pharmacist, she said, sits at the center of that ecosystem, tracking every dose and refill and maintaining the most sustained contact with the patient of any stakeholder involved.

Swoope added that specialty pharmacies already generate the clinical detail sponsors need, biomarker results, lab values, and notes on “just-in-time” moments like a flare or an asthma attack, without requiring new point solutions to capture it. That data is increasingly recognized as valuable beyond the pharmacy counter: health-system specialty pharmacies already document adherence, adverse events, and time to therapy initiation or discontinuation in more granular detail than routine physician notes capture, prompting one health-system pharmacy leader to describe the data as “closest to the patient journey.”²

On the sponsor side, similar real-world data has already been credited with reducing the protocol amendments that commonly follow a trial’s launch by testing inclusion and exclusion criteria against real patient populations before a study begins.³

Valbh went further, challenging pharmacies to start asking a question she believes almost none currently do.

“I’m pretty sure 9 out of 10 specialty pharmacies are not asking this question in their clinical assessments, in their welcome calls,” she said. “Could you imagine asking the question, ‘Are you part of a clinical trial, yes or no?’”

That single data point, she argued, could flag patients for different monitoring and open a direct communication line with their trial site, turning routine pharmacy contact into a tool for closing the access gap the panel spent an hour describing.

References

1. Caffrey M. To attain diversity in clinical trial enrollment, it takes a village. AJMC^®. February 15, 2024. Accessed September 23, 2026. https://www.ajmc.com/view/to-attain-diversity-in-clinical-trial-enrollment-it-takes-a-village
2. Hohmann E, Phung T, Chandra K. Why pharma should be paying attention to health system specialty pharmacy data: Kanika Chandra, PharmD; Tiffany Phung. AJMC. May 8, 2026. Accessed September 23, 2026. https://www.ajmc.com/view/why-pharma-should-be-paying-attention-to-health-system-specialty-pharmacy-data-kanika-chandra-pharmd-and-tiffany-phung
3. Steinzor P, Li G. Real-world data, digital patient profiles are revolutionizing trial design, patient recruitment: Gen Li, PhD, MBA. AJMC. August 4, 2025. Accessed September 23, 2026. https://www.ajmc.com/view/real-world-data-digital-patient-profiles-are-revolutionizing-trial-design-patient-recruitment-gen-li-phd-mba