When Survival Comes First, Trials Come Last
By Dan Schell, Chief Editor, Clinical Leader
Clinical trials may offer care — but they don’t offer rent, gas, or groceries. And lately, that’s the kind of support patients need most.
Claudia Martorell, MD, MPH, FACP, a PI and infectious disease specialist in Springfield, MA, has spent 20 years running a clinical research site with a clear purpose: improve access for underserved, underrepresented patients. Her practice sits at the intersection of clinical care and research, operating under a hybrid model. Some patients are treated through traditional insurance-based visits; others receive care through clinical trials.
And increasingly, the patients who rely on those trials are slipping away.
“I’ve had patients living in their cars,” she says. “They were housed before — now they’re evicted. I’ve seen people with insurance lose it. People who were stable before who now can’t get to visits, can’t fill prescriptions, can’t get labs done. And if they can’t take care of their basic needs, they’re not going to join a study.”
She’s not the only one seeing this trend, but she may be among the first to name it so directly: the compounding pressure of healthcare cuts and economic instability is pushing patients out of trials — particularly the very populations that sponsors and regulators have spent the last few years trying to include.
A SITE BUILT BUILT FOR REPRESENTATION
Martorell’s site, based in a heavily Puerto Rican section of Western Massachusetts, serves a racially and linguistically diverse community often overlooked in healthcare and research. Her staff reflects that population — most are bilingual, and all are trained to engage patients who may be wary of the medical system.
She personally recruits most participants, especially if they’re coming in for a clinical visit and might be eligible for an active trial. That approach isn’t just efficient — it’s strategic. She understands the barriers minority patients face, and she knows trust is a key issue.
“The fact that I’m Puerto Rican doesn’t mean I automatically understand every minority’s challenge,” Martorell says. “But my training in minority health policy helps me meet them where they are.”
That trust also shapes how she handles consent. Martorell often walks patients through informed consent forms herself, sometimes over multiple visits, to ensure they fully understand the protocol. She covers potential side effects, visit schedules, and compensation — and makes it clear that participation is voluntary and won't affect the care they receive.
That level of involvement is rare among PIs, but for her, it's necessary. “They may not know the coordinator,” she says. “But they know me.”
IT’S GETTING HARDER FOR PATIENTS TO PARTICIPATE
While her site provides care through both insurance and research, the increasing strain on patients’ everyday lives is making participation harder, regardless of model. Several patients have lost their health insurance in recent months. Others are unable to afford even modest copays, which affects their ability to get medication or labs done, sometimes even for trials.
Transportation is another issue. Some studies offer support; many don’t. Even though Martorell’s site is centrally located with a bus stop nearby, that only goes so far for patients juggling jobs, childcare, or no longer living at a fixed address.
The most alarming change? Patients disappearing. Martorell and her team have begun losing contact with participants in active studies — people they’d typically see regularly. “We’ve sent texts, letters, certified mail, and still can’t reach them,” she says. “We don’t know what happened. That’s never a good sign.”
When the basics of life are uncertain, showing up for a study visit is simply not a priority. And that’s where the data gaps begin.
WHEN DIVERSITY LOSES MOMENTUM
Over the past several years, the push for diversity in clinical trials gained traction, with FDA guidance, sponsor initiatives, and site-level programs all aligned around improving representation. Martorell saw the change firsthand. Sponsors began looking not just for fast enrollers but for sites with the cultural and logistical capacity to reach underrepresented patients.
That momentum, however, is already showing signs of stalling. DEI initiatives at some pharmaceutical companies have quietly disappeared. At the policy level, anti-DEI rhetoric and restructuring have introduced confusion and hesitation about what’s still expected — or even allowed.
“I’ve already heard comments from other providers,” Martorell says. “There’s a lot of uncertainty, and people are starting to make their own assumptions about what’s changing.”
She worries that without clear incentives or requirements, inclusion will once again fall by the wayside. And that could mean trials that don't reflect the patients who most need the interventions.
“People will say, ‘This drug works — but not for someone like me.’ And they’re not wrong,” she says.
THE CHALLENGES OF LONG TRIALS
Because Martorell specializes in infectious diseases like HIV and hepatitis C, many of the trials at her site run for years — not weeks or months. These longer timelines make consistency critical. But they also raise the risk of interruptions. Substance use relapse, incarceration, or changes in housing status can all derail participation.
When that happens, Martorell sees more than just a missing data point. She sees a patient at risk of falling through the cracks entirely. And when multiple patients disappear or disengage from care, the loss compounds — not only for the trial, but for the larger goals of public health equity.
She’s also tracking a surge in sexually transmitted infections among her patient base, which she views as a warning sign. “Those are usually the first step toward acquiring HIV,” she says. “And they’re happening more when people are under social stress.”
SUSTAINING PROGRESS WON’T BE EASY
Despite the policy shifts and real-world challenges, Martorell remains committed to the work. Her site is running seven active studies, with more on the way. She continues to create short bilingual videos for social media to explain study opportunities in plain language. Sponsors still come to her with protocols because they know she can reach a population that others can’t.
But she’s realistic about what it’s going to take to sustain progress.
“We need policies and systems that reflect what people are actually going through,” she says. “You can’t build representative data on unstable lives. If we want trials that reflect the real world, we have to stop pretending that people’s survival needs are separate from their healthcare needs.”
At her site, that line disappeared a long time ago.