JMIR news: Diversity under threat as clinical trials face disruptions

Clinical trial diversity under threat: JMIR Publications highlights the high cost of research disruptions and the path forward

JMIR Publications

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Virginia Gewin, JMIR Correspondent

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Credit: JMIR Publications

 

(Toronto, May 4, 2026) JMIR Publications today featured a critical new story in its News and Perspectives section examining the recent waves of disruption to inclusive clinical trials and the emerging strategies to keep health equity on track. The article, "Keeping Clinical Trials on an Inclusive Track," authored by Virginia Gewin, details how recent shifts in federal policy and funding have impacted hundreds of trials designed to study disease burdens in underrepresented populations.

The report highlights the harrowing case of Dr. Dinushika Mohottige, whose NIH-funded study on kidney disease in Black individuals was abruptly terminated in early 2025 following a White House Executive Order targeting DEI programs. While funding was eventually restored after a lawsuit, the 10-month delay in recruitment resulted in potential participants falling seriously ill or passing away.

The Human and Economic Cost of Underrepresentation

The feature underscores a systemic crisis in medical research:

• Disruption at Scale: In 2025 alone, 383 clinical trials were disrupted, affecting more than 74,000 participants. Trials focusing on infectious diseases, prevention, and behavioral interventions were hit the hardest.

• The Diversity Gap: Research shows that fewer than 20% of drug trials conducted between 2014 and 2021 had data relevant to the specific benefits or side effects for Black patients.

• A Multi-Billion Dollar Problem: Experts warn that failing to characterize drug efficacy across diverse ethnic groups could cost hundreds of billions of dollars in reduced life expectancy and disabilities over the next 25 years.

Bridging the Gap: Digital Tools and Patient Advocacy

To counter these structural barriers, the report explores two primary avenues for maintaining inclusive recruitment:

• Digital Innovation: Clinicians are increasingly using AI and machine learning to mine electronic health records (EHRs) for ideal participants and utilizing social media for culturally tailored outreach. However, experts like Dr. Sonia Anand warn that a digital literacy gap and a lack of trust in data privacy among non-White individuals could inadvertently widen the health equity gap if not managed carefully.

• Community-Centered Design: The article advocates for participation-to-prevalence ratios and the inclusion of patient advocates from day one. Robert Sanchez, a patient advocate working with Dr. Mohottige, emphasizes the need for a human-centered approach to data, stating, "Numbers need to have a soul."

A Call for Long-Term Investment

The report concludes that while reaching diverse populations involves higher up-front costs, the long-term impact on public health and economic stability is undeniable. By leveraging community partnerships and refining digital tools, the medical community can move toward trials that accurately reflect real-world populations.

 

Please cite as:

Gewin V. Keeping Clinical Trials on an Inclusive Track. J Med Internet Res 2026;28:e99011

URL: https://www.jmir.org/2026/1/e99011

DOI: 10.2196/99011

 

About JMIR Publications News and Perspectives

JMIR Publications is a leading open access publisher of digital health research. The News and Perspectives section is the newest addition to its portfolio, established to bring the rigor and integrity of academic publishing to scientific journalism. The section features well-researched, expert-driven content from the Scientific News Editor, Kayleigh-Ann Clegg, PhD, and a network of specialist JMIR Publications Correspondents to keep the digital health community informed, inspired, and ahead of the curve.

 

About JMIR Publications

JMIR Publications is a leading open access publisher of digital health research and a champion of open science. With a focus on author advocacy and research amplification, JMIR Publications partners with researchers to advance their careers and maximize the impact of their work. As a technology organization with publishing at its core, we provide innovative tools and resources that go beyond traditional publishing, supporting researchers at every step of the dissemination process. Our portfolio features a range of peer-reviewed journals, including the renowned Journal of Medical Internet Research. 

To find out more about JMIR Publications, visit jmirpublications.com or connect with them on Bluesky, X, LinkedIn, YouTube, Facebook, and Instagram.

 

Media Contact:

Dennis O’Brien, Vice President, Communications & Partnerships, JMIR Publications

communications@jmir.org, +1 416-583-2040

The content of this communication is licensed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, published by JMIR Publications, is properly cited.

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Journal

Journal of Medical Internet Research

DOI

10.2196/99011 

Method of Research

Commentary/editorial

Subject of Research

People

Article Title

Keeping Clinical Trials on an Inclusive Track

 

Big Brothers Big Sisters linked to lower violence and substance use among youth

University of Illinois Chicago

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Two individuals sit outside, talking at the Big Brothers Big Sisters mentorship program.

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Credit: Photo: David DuBois

Mentorship programs are valued by parents and communities for their ability to improve the self-esteem and relationships of youth participants. Now, new research from the University of Illinois Chicago shows that kids who participate in Big Brothers Big Sisters, the oldest and largest such program in the United States, are less likely to engage in violent behavior or substance use than those who don’t.

For the randomized control study, published in the Annals of the New York Academy of Sciences, UIC researchers followed the trajectories of more than 1,300 kids ages 10 and older through four years of interviews, surveys and official records. In addition to decreased likelihood of violence and substance use, the study authors found that kids in the program reported higher self-esteem and overall mental health compared to their counterparts who did not participate in Big Brothers Big Sisters.

“Mentoring has the potential to influence youth in almost any area of their health and development,” said David DuBois, professor emeritus in the UIC School of Public Health and lead author of the work. With a large and long-term study, DuBois and his co-authors hoped to provide hard data for those impacts.

“With this study, we wanted to update the evidence, expand the time horizon to better capture the full extent of this program and also expand the scope to look at other areas where young people might benefit,” he said.

Founded in the early 1900s, the Big Brothers Big Sisters program partners youth with volunteer adult mentors. Once matched up, the pairs regularly spend time together doing activities aligning with the “Little’s” interests, while program staff have regular check-ins with the pairs.

“Where the rubber meets the road is in the relationship building,” said DuBois, who himself has volunteered as a “Big” in the program years ago. By getting to know the child, their family and their interests and forming a meaningful connection the hope is to have a positive impact in that child’s life, he said.

“Unlike many programs out there in the community for the young people, it doesn’t have a defined beginning and end point. Families and mentors typically are asked to make an initial commitment of one year. But often the relationship continues well beyond this time frame and can deepen, potentially over several years. That was one thing we wanted to expand on in the study by following youth over several years,” DuBois said.

Big Brothers Big Sisters affiliates operate in all 50 states, in rural, suburban and urban communities. For the study, the researchers worked with 17 Big Brothers Big Sisters affiliates in in 13 states located in cities like Los Angeles and Peoria that serve youth comprising a cross section of demographic backgrounds.

Using industry-standard questions designed by groups such as the National Institutes of Health and the Centers for Disease Control and Prevention, the researchers surveyed participants and their parents on the children’s mental health, educational progress, substance use and social and personal skills. They also looked at official records to track any arrests of participants and tracked responses after 18 months and four years.

After a year and a half in the program, “We were already seeing the benefits for substance abuse, delinquent behavior and some things like aggressive tendencies,” DuBois said. And at the four-year mark, youth participants reported significantly lower rates of depressive symptoms and suicidal ideation.

“As the relationships got deeper, it seems that something about the mentoring experience allowed youth to be more resilient to risks for mental health issues,” DuBois said.

The kids also reported higher rates of life satisfaction and self-esteem. From their perspective, “there was somebody in the world who wanted to spend time with me, for no reason other than that they enjoyed it,” DuBois said. “And that’s good for your mental health.”

DuBois hopes the study and its findings reinforce appreciation for the benefits of investing in programs like Big Brothers Big Sisters. Though program mentors serve as volunteers, a large amount of paid staff time is required to match youth with mentors and help keep the program going.

And though the study focused on Big Brothers Big Sisters, DuBois said, the benefits of mentorship extend to other opportunities, as well.

“There is value in being a caring attentive adult, whether as a Little League coach, a Girl Scout troop leader, or whatever the case may be,” he said.

DuBois’ own experience serving as a Big Brother shows the potential rewards reaped by the adult mentor. “It reached me at a time when I was making my way forward in my first job as a professor, working really hard and not developing a lot of outside interests and activities,” DuBois said. Matching with his mentee gave him a new purpose. “It really greased the wheels for me to be out in the community.”

Other UIC authors of the study include Julius Rivera, Vanessa Brechling and Staci Root.

Written by Tess Joosse

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Journal

Annals of the New York Academy of Sciences

 

Maintaining a healthy heart may require regular doses of positivity

University of Illinois at Urbana-Champaign, News Bureau

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Positive psychology practices such as mindfulness and gratitude journaling can lower cardiovascular risk factors within weeks; however, lasting success may require periodic reinforcement, social work professor Rosalba Hernandez and her colleagues suggest in a new study.

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Credit: Photo by L. Brian Stauffer

CHAMPAIGN, Ill. — Positive psychology interventions such as mindfulness, gratitude journaling and optimism training can consistently improve blood pressure, inflammation markers and other cardiovascular disease risk factors within a matter of weeks, a recent study found. However, since these benefits are associated with lifestyle changes such as eating healthier and greater physical activity, the researchers suggested that ongoing reinforcements may be needed to stay on course long term.

Rosalba (Rose) Hernandez, a professor of social work at the University of Illinois Urbana-Champaign, led a team that analyzed the findings of 18 randomized controlled trials that used positive psychological and mindfulness interventions to enhance mental or physical health.

The programs that the team reviewed included individual methods — such as structured telephone sessions, journaling with brief check-ins and digital platforms such as apps and text messaging — and interactive in-person group sessions, as well as hybrid formats that blended these with online tools and virtual meetings. Most of the programs consisted of weekly sessions and at-home activities that reinforced the skills taught, with the majority of programs lasting from six to 12 weeks, the team found.

In general, the programs included 50-200 adults with elevated cardiovascular risk factors such as uncontrolled hypertension, heart failure or other conditions. Typically, the participants were in their late 50s to mid-60s, and women comprised 35-55% of the samples across those studies that reported their participants’ gender, according to the researchers.

“In hypertension and postacute coronary syndrome cohorts, mindfulness-based programs delivered over an eight-week period reduced systolic blood pressure and lowered inflammatory markers such as high-sensitivity C-reactive protein and fibrinogen,” said Hernandez, who is a Fellow of the American Heart Association. “A 12-week spirituality-based digital intervention achieved one of the largest reductions — reducing systolic blood pressure measured with a standard cuff by 7.6 points, and central systolic pressure — which is measured in the aorta as it leaves the heart — by 4.1 points.”

In prior research on positive psychology interventions, scientists seldom defined the dose that was needed to obtain the beneficial effects, Hernandez said. She and the team members sought to clarify the frequency and duration that was most likely to improve individuals’ cardiovascular health.

Programs that had more frequent contact with their participants yielded the most consistent physiological benefits, underscoring the opportunity to embed positive psychological strategies into long-term cardiovascular care, Hernandez said.

The team found that the strongest behavioral improvements were achieved by an eight-week program delivered over WhatsApp that combined weekly sessions with daily microtasks, motivating participants to engage in greater physical activity, eat a healthier diet and take their medication as prescribed. A program that included motivational interviewing succeeded in increasing cardiac patients’ levels of physical activity by 1,800 steps a day and their medication adherence, while the mindfulness programs improved participants’ activity levels and diets only, according to the study.

“The therapeutic dose that was most consistently linked with improvements in blood pressure, inflammation and endothelial function was daily practice reinforced by weekly sessions over eight to 12-week periods,” Hernandez said. “Therapeutic dosing typically involved high-frequency dosing over this time period to obtain short-term physiologic benefits, while ongoing less-intensive contact may be needed to sustain behavioral change.”

Published in the journal Cardiology Clinics, the study was co-written by University of South Florida social work professor Soonhyung Kwon; Alyssa M. Vela, a professor of surgery and of psychiatry and behavioral sciences at Northwestern University Feinberg School of Medicine; and Katharine S. Edwards, a professor of cardiovascular medicine and of psychiatry and behavioral medicine at Stanford Medicine.

“The findings of this study further point to the importance of attending to mental and behavioral health for cardiovascular disease prevention and cardiovascular health optimization,” Vela said. “This speaks to the need for routine screening and integration of cardiac behavioral medicine to allow for access to important interventions.”

The current study adds to a growing body of research linking psychological well-being — including traits such as optimism, positive affect and gratitude — with cardioprotective benefits.

The work was built upon the findings of a prior study led by Hernandez that found that people who were the most optimistic had healthier hearts. That paper was published in the journal Health Behavior and Policy Review.

Funded by the National Institutes of Health and the National Center for Research Resources, that paper was co-written with preventive medicine professors Kiarri N. Kershaw, Juned Siddique and Hongyan Ning, all of Northwestern University Feinberg School of Medicine; preventive medicine and epidemiology professor Donald M. Lloyd-Jones of Boston University Chobanian and Avedisian School of Medicine; psychology professor Julia K. Boehm of Chapman University; social and behavioral sciences professor Laura D. Kubzansky of Harvard University School of Public Health; and Distinguished Professor of Epidemiology Dr. Ana Diez Roux of Drexel University.

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Journal

Cardiology Clinics

DOI

10.1016/j.ccl.2025.12.001 

Method of Research

Meta-analysis

Subject of Research

People

Article Title

Positive Psychology Interventions and Cardiovascular Health: Frequency and Duration to Sustain Cardiovascular Benefits

 

New guidelines help long-term care communities support residents’ intimacy and dignity

Practical framework offers staff clear guidance on consent, communication, and person-centered care

Hebrew SeniorLife Hinda and Arthur Marcus Institute for Aging Research

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Intimacy doesn’t disappear in long-term care, but clear guidance on how to support it often does. A new paper outlines a practical framework for how organizations can move from uncertainty and inconsistency to a structured, ethical approach that respects residents’ autonomy while protecting their safety. At the heart of the model is the creation of a dedicated Sexual Health Committee, a multidisciplinary team charged with developing policies, guiding staff, and helping communities navigate one of the most sensitive — and often avoided — aspects of care.

Entitled “Enhancing Sexual Well-Being in Long-Term Care: A Framework for Effective Guidelines,” and published in Annals of Long-Term Care, the framework begins by establishing a Sexual Health Committee that brings together professionals across disciplines to lead this work. The Sexual Health Committee’s mission is clear: to support healthy sexual expression for all residents, including those with cognitive impairment, within well-defined ethical and professional boundaries.

Those boundaries are explicit to ensure that resident rights are balanced with safety and professional standards.

The paper’s primary focus is on helping organizations build their own approach. The authors encourage organizations to adapt the Sexual Health Committee model and resulting guidelines to their specific population, culture, and resources.

It lays out a process other communities can follow, with three core pillars:

1. Ground the work in values, laws, and ethics.
   Before drafting policies, organizations are encouraged to define their cultural values and align them with state and local regulations, and the ethical codes of clinical and caregiving professions. This ensures that any guidelines are both compliant and consistent with the organization’s identity.
2. Develop clear, standardized policies and procedures.
   The Sexual Health Committee then translates those principles into practical guidance — creating written policies that address real-world situations, reduce ambiguity, and support consistent decision-making across staff.
3. Educate, apply, and adapt.
   Training is essential to making the framework work. Staff are taught how to apply the guidelines in practice, including how to assess consent and respond appropriately. The Sexual Health Committee also serves as an ongoing resource, helping teams navigate complex cases and refine policies over time.

“Intimacy and connection remain important parts of life, even in long-term care,” said Rachael F. Arielly, PsyD, a psychologist specializing in geropsychology at Hebrew Rehabilitation Center and a co-author of the paper. “This framework is designed to help organizations create thoughtful, consistent approaches that reflect their values, support residents, and give staff the guidance they need.”

For residents and families, these guidelines reflect a shift toward more person-centered care that recognizes sexual well-being as part of overall quality of life. By promoting healthy sexual expression and establishing clear, consistent guidelines, communities can better support residents’ rights while helping staff navigate complex situations in a way that is both respectful and appropriate.

In addition to Arielly, co-authors included Nathalie Huitema, PhD, a clinical sexologist and Certified Sexuality Educator, and Sarah J. Rogers, LICSW, a clinical social worker and certified sex therapist.

About Hebrew SeniorLife
Hebrew SeniorLife is a national leader working to create a world where aging is defined by possibility, not limitation. We care for more than 4,500 older adults each day across seven campuses throughout Greater Boston, and offer support for families in the aging journey. Our services include in-home care, outpatient therapies, an outpatient memory clinic, short- and long-term inpatient care, hospice, independent and assisted living, and affordable housing with services. We conduct influential research on aging at our Hinda and Arthur Marcus Institute for Aging Research, which has a grant portfolio of $87 million, and train future health care workers at the Lunder CareForce Institute. Hebrew SeniorLife is a Harvard Medical School affiliate. Follow us on our blog, Facebook, Instagram, and LinkedIn.

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Journal

Annals of Long-Term Care Clinical Care and Aging

DOI

10.25270/altc.2026.31.002 

Method of Research

Commentary/editorial

Subject of Research

People

Article Title

Enhancing Sexual Well-Being in Long-Term Care: A Framework for Effective Guidelines

 

New study gives voice to older homeless women navigating streets and shelters

Boston University

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For women in their 50s experiencing homelessness, daily life means far more than finding a place to sleep. It means navigating dangerous shelter environments, managing serious health conditions without adequate support, and fighting to maintain dignity in a system that was never designed for them. A new study by Boston University School of Social Work (BUSSW) Professor Judith Gonyea puts their experiences at the center.

Published in Frontiers in Global Women’s Health, the study was co-authored by Professor Gonyea and Kelly Melekis of the University of Vermont. Their research examines how older women experiencing homelessness navigate life on the streets and in emergency housing shelters, and how those environments affect their physical and emotional well-being, their sense of self-worth, and their path toward stable housing.

A Population Falling Through the Cracks

Women in their 50s experiencing homelessness occupy a particularly precarious position. Too young to qualify for federal old-age benefits and typically without minor-age children, they often fall between the targeted populations that safety net programs are designed to serve. At the same time, due to poor nutrition and harsh living conditions, many experience accelerated aging, presenting with chronic health conditions more commonly seen in housed women in their 70s and 80s.

Although one of the fastest-growing groups within the homeless population globally, older women experiencing homelessness have remained largely absent from research and policy conversations. This BUSSW study seeks to change that.

What the Research Found

Professor Gonyea and Melekis conducted in-depth interviews with 15 women in their 50s experiencing homelessness in an urban northeastern U.S. city. The majority identified as women of color. Trauma was nearly universal among participants, and most were managing significant physical and mental health challenges.

Five key themes emerged from the interviews, each reflecting how shelter environments intensify the daily struggles these women face. Participants described shelters as dehumanizing places where they were reduced to a bed number rather than recognized as individuals.

They reported feeling unsafe, often describing shelter life as akin to prison, requiring constant hypervigilance to protect themselves from bullying, theft and potential violence. Many found the harsh physical conditions of shelters, including bunk beds ill-suited to older bodies, limited privacy and inadequate resources, to be in direct conflict with their health needs. Rigid rules and protocols left women feeling stripped of control and autonomy. And the absence of stability and normalcy, from unpredictable daily schedules to compulsory daytime displacement onto the streets, wore heavily on their sense of self and hope for the future.

Despite these challenges, the women demonstrated remarkable resilience and resourcefulness, finding creative ways to maintain their appearance, preserve their belongings, and hold onto a sense of identity beyond homelessness.

Why This Matters

The findings point to an urgent need to transform both the physical and social environments of emergency housing shelters using trauma-informed and aging-responsive approaches. The authors call for shelters to move away from authoritarian, one-size-fits-all practices and toward models that recognize the distinct needs of older women, including those related to health, trauma, safety and dignity.

As the number of older adults experiencing homelessness continues to grow, Gonyea and Melekis state that older women must no longer be invisible in research, policy or practice. Their voices and their experiences must be part of the solution.

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Journal

Frontiers

DOI

10.3389/fgwh.2026.1697164 

Method of Research

Survey

Subject of Research

People

Article Title

Walk in our shoes: older homeless women's perceptions of the challenges of navigating streets and shelter life