Trials and Errors

By Madeleine Burry
October 3, 2025 | VOLUME 3, ISSUE 3

Without ongoing research to identify new medications and best practices for interventions, health care stands still. It’s important not only that research continues but that researchers have the resources needed to conduct comprehensive studies. Efforts to eliminate unintended bias in studies and clinical trials are crucial for maintaining the confidence of health care professionals and their patients.

That means careful consideration of what gets researched, who leads and participates in studies, how studies are implemented, and more funding—not less.

“It’s fundamental that we try to minimize [bias in medical research] because there could be implications and consequences related to efficacy or safety. So the more transparent and less biased the research, the better the care that will be given to patients,” said Dominique Demolle, PhD, Chief Executive Officer at Cognivia, a manufacturer of analytical tools to improve clinical trials.

Strengthening safeguards in clinical research

Even with safeguards in place, disparities can emerge: Study participants may give immoderate responses to questions, participation can lead to behavior changes (the Hawthorne effect), and study makeup can favor certain groups. Research studies may be limited in scope due to various factors and must be reviewed through this lens. For this reason, it is essential to understand how these disparities can present themselves.

A lack of diversity in participants

There’s a long history of clinical trials made up solely or primarily of a White male population. To counteract this, in 1993, the National Institutes of Health (NIH) began requiring women and underrepresented populations to be included in clinical studies.^1,2

Research that limits diversity does a disservice—people’s reactions to medications and interventions can vary based on age, sex, or ethnicity. Expansion of test groups is the necessary step to address this limitation.

“We have made some advances [in improving diversity in clinical research], but there's still more work to be done,” said Anita Phung, MRGCP, MRCP, MBBS, a general practitioner who helps oversee clinical trials at Lindus Health, a clinical research organization. A review of 20 years of registered clinical trials in the United States revealed that only 43% of studies reported data around ethnicity, and, when provided, 79% of enrollees were White individuals.³

Designing unbiased studies can be challenging. Researchers balance fair representation of various demographics with keeping the sample size affordable, Dr. Demolle said. And some groups can be hard to recruit for a variety of reasons, including lower health literacy levels and socioeconomic factors (such as lower income or curtailed time due to caretaking responsibilities). Funding for recruitment and outreach to underrepresented communities is often restricted.

Limited access to studies

Studies with positive outcomes appear more frequently in journal publications. When studies with adverse outcomes aren’t readily available in credible resources, findings in a given area show only a portion of the picture. Being able to assess and factor in negative implications is as crucial as the positive ones in offering the best in patient care.

“It’s very, very important to publish all the negative trials. Ultimately, the more data there [are], the more we can appraise [them] and be critical about [them]... [and they] can contribute to the wider evidence base,” Dr. Phung said.

As a next step, Dr. B. wanted to study another important respiratory disease to see how it would be affected by shifting to a race-neutral metric.

However, his research is currently on hold. “Technically, my diversity supplement expired and just wasn't extended. But it was a kind of situation where, at least as I understand, they routinely had been offering these extensions and just didn't because of the changes in policy,” Dr. B. explained. As a result, his institution is now trying to marshal internal funding resources, and he’s seeking out alternate funding.

“It really slowed down my productivity,” Dr. B. said.

A grant to improve lung cancer screening guidelines

Also on hold: Dr. N.’s research to improve lung cancer screening rates.

Less than 20% of eligible individuals get a low-dose CT scan to screen for lung cancer.^10,11 This “is [a] really stark comparison to other cancer screening exams,” Dr. N. said. Providers may not be recommending the insurance-covered screening because expanded recommendation guidelines are new, and time is short during appointments.¹² “And lung cancer is unique. There's a lot of stigma around smoking,” Dr. N. said. Fear of the results can also be a blocker in getting screened.

This combination of a screening test that can reduce cancer mortality and a low adoption rate leaves room for opportunity. Getting recommendations from trusted messengers—people who come from within one’s community—could lead to increased uptake of low-dose CT scans and tobacco treatment, Dr. N. said. Plus, it would remove one item from providers’ to-do lists during brief appointments with patients. Dr. N. and his team have already developed a messaging prototype and training process for health workers.

When Dr. N. submitted his grant application to the National Cancer Institute, he received the highest-possible impact score. His funding was ultimately provided via a diversity mechanism (Dr. N. is from an underrepresented group in medicine). But now these efforts to increase uptake in lung cancer screening are on hold because his funding was cut.

“We're ready to start training patient navigators and roll out the trial, except now we don't have funding to pay the patient navigators or the research participants,” Dr. N. said. An extra layer of frustration is his belief that “if I wasn't a diversity applicant, my grant would have been funded, and it wouldn't be under threat of being cut,” he said.

Funding cut ramifications

Clinical research funding cuts have a ripple effect, from people in health care to patients—which affects everyone at some point.

When funding is suddenly cut, it’s an emotional experience for the researcher who has personally committed to improving health outcomes through study.

One of the first things Dr. N. felt was doubt. “You start questioning yourself as an individual. Is it because my work is not meaningful?” he said. He’s frustrated for the people who worked with him to design the intervention, as well as for his patient navigator partners and potential study participants.

Ongoing legal battles, an overall lack of clarity, and digging to find alternate funding can make the experience even more dizzying.

A disservice to health

There’s value to studying marginalized and vulnerable populations for everyone who needs health care.

Consider the proverbial canary in a coal mine. These songbirds were not sent underground for their melodic noises. Rather, it’s “because they had a more frail respiratory system,” Dr. B. said. When poisonous gases amassed, canaries would be affected first, pausing their singing and indicating that an evacuation was merited for humans. Dr. B. continued with his analogy: “When there's a problem in our health care system, eventually it will impact everybody. But you can often see those impacts first or most easily among the populations that are already in that marginalized position.”

A burden on the health ecosystem

Clinical research is a long, cooperative endeavor.

“There is no scientific question that you can ask today and answer tomorrow to change the state of health care,” said Bert Hartog, PhD, the founder of Hartog Digital Health Consulting, who has decades of experience in clinical trial development. Time is required to know what questions to ask, to design and perform research, and to understand the results.

Interrupting that process has an effect like reducing oxygen levels, he said. “That doesn't mean it will die, because you can survive on reduced oxygen, but you will thrive much less, and you'll be less healthy,” he said. Research output may be reduced and less strong. The effects will potentially be uneven—just as reducing oxygen levels is more challenging for some individuals than others, reducing funding will be harder for some programs than others, Dr. Hartog said.

The impact of politically motivated fiscal cuts in a targeted area of medical science is further hindering the pursuit of sound, diverse, unbiased, science-based medicine. Clinicians and researchers do not yet know how to navigate, avoid, or overcome this new reality.

But the ripple effect will come down to patients, as it always does. “Some people will suffer because their treatment will not be developed,” Dr. Hartog said. “And what is being developed will take longer.”