Vaccine trials underrepresent large segments of the population, while women are overrepresented, says a study published recently on the JAMA Network Open.

“In this cross-sectional study of 230 US-based clinical trials with 219,555 participants, Black or African American, American Indian or Alaska Native, Hispanic or Latino, and older adults were underrepresented and women were overrepresented compared with the US population,” the research study authors wrote.

Equally significant was the lack of ethnic and racial data reported by trial managers.

“One of the most important findings,” the report says, “Was that despite FDA recommendations, many studies were not complying with reporting guidance regarding demographic characteristics of the study population.”

The researchers found only 34% of the trials reported ethnicity; 58% reported race. All included age and sex data.

“This is a massive gap in information, and if we want to improve enrollment in clinical trials and we want to see diversity in clinical trials, we need the data,” Steven Pergam, an author on the paper told StatNews. “It’s amazing that we don’t have the data.”

Of the trials that did report race, that reported race, Black adults accounted for 11% of the trial participants, 6% were Asian less than one-half of 1% were American Indians, Alaska Natives, Hawaiian or Pacific Islanders.

Whites were 78% of all participants.

In the 79 trials that reported ethnicity, Hispanics and Latinos accounted for 12%.

The imbalance was even more striking in phase 3 trials. There, only 7% of the participants were Black or African American.

“Similarly,” the report says, “Native Hawaiian and Pacific Islander, American Indian and Alaska Native, and Hispanic or Latino participants were underrepresented in phase 3 trials compared with their representation in the US population.”

“Despite advancements, equity in clinical trial enrollment remains an issue,” the report observes.

representation in vaccine trial chart blog.jpg

The underrepresentation of minorities became an issue during the COVID vaccine trials, as pharmaceutical firms struggled to recruit volunteers. Early into the pandemic, a group of US senators wrote to the pharmaceutical companies involved in the Warp Speed vaccine development program saying trials “must include participants that racially, socioeconomically, and otherwise demographically represent the United States.”

It was that difficulty that prompted the writers of the recent paper to study the demographic make-up of vaccine trials over the last decade. Though the differences between the trial participants and the general population were not great, the disparities are enough to be troubling, the researchers said.

“Small inequities are still important inequities,” Laura Flores, lead author on the study told StatNews. “We’re doing a genuine disservice to these populations by not reaching out and not keeping records or not including them in trials that might benefit them.”

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Jun 6, 2023

COVID Trials Raising Awareness of Clinical Diversity

Minority representation in clinical trials is an issue the coronavirus vaccine trials has brought out of medical publications and journals and into the broader media.

In just the last few weeks, discussions of the need to ensure Black, Hispanic, Asian and other ethnic minority participation in the trials have appeared on NPRABCCNBC and elsewhere.

“If Black people have been the victims of COVID-19, we’re going to be the key to unlocking the mystery of COVID-19,” Rev. Anthony Evans, president of the National Black Church Initiative, told the Los Angeles Times.

Recruiting minorities for clinical trials is not a new issue. Five years ago, the FDA’s Center for Drug Evaluation and Research began publishing demographic summaries of clinical trials. The reports are in response to a Congressional mandate “to report on the diversity of participants in clinical trials and the extent to which safety and effectiveness data is based on demographic factors such as sex, age, and race.”

A recent article on the pharmaceutical news site PMLive carried the headline “If our patients are diverse, why are clinical trials so white?” The article notes that, “Although 20% of the people living with multiple myeloma (cancer of plasma cells) in the US are African Americans, they only account for 6% of all patients in clinical trials.”

Clinical trial managers and researchers are making an effort to diversify their patient volunteers. Writing in Stat, Jocelyn Ashford, a patient advocate and trial recruiter, says creating an inclusive clinical trial requires engaging “the target community in discussions around the recruitment plan. By bringing these communities to the table early, we can hear their input instead of making assumptions about how to best reach them.”

In recruiting Black participants, she’s reached out to historically Black fraternities and sororities. “These organized groups of educated, social-minded individuals are looking to give back to their communities and can act as bridges to their parents, grandparents, and the Black community more broadly.”

Forbes last year suggested that a key to increasing minority representation is to make it easier for minorities to participate by designing ways to gather the data via wearables. It’s also important, says the Forbes article, that clinical trial investigators themselves be representative of different groups.

Citing a Clinical Research Pathways report on “Diversity in Clinical Trials,” Forbes observes that “patients from minority communities are more likely to enroll when they learn about studies from doctors in their own communities.”

For the earliest of the COVID trials, Moderna is getting help from Dr. Carlos del Rio, executive associate dean at the Emory University School of Medicine in Atlanta. He has a record of successfully recruiting minority trial volunteers, according to Kaiser Health News.

Said del Rios, “We’re trying to do our best to get out to the communities that are most at risk.”

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Jun 6, 2023

Lies and Deceit Plague Clinical Trials

The publicity around the current COVID vaccine clinical trials has done much to make the public aware of the difficulties researchers face to ensure the safety and effectiveness of the therapy being tested.

Besides the now well-known need to recruit participants representing all age groups, races, and other demographics, clinical trial managers also have to be on the lookout to avoid what the pharma community has come to call “professional study subjects.”

These individuals are so eager to participate in a clinical study they lie about their medical condition, misrepresent their lifestyle, fail to disclose medications they take and may participate in more than one, even several studies simultaneously.

Eric Devine, PhD, assistant professor of psychiatry at Boston University School of Medicine, says, “I was doing clinical trials and I was running into people who were just lying to me. It was blatant when I looked at their medical records.”

Money is what motivates most professional study subjects, according to a Medscape report. Many trials pay participants, enabling some to earn thousands of dollars. One man who entered an Alzheimer’s trial legitimately earned $31,000.

Others may be driven to participate because of free medical treatment. The Medscape report mentions one woman who lied to get into a trial involving botulinum toxin. “I wanted to get into the study. I wanted free Botox, so I participated. And I got paid — so why wouldn’t I?”

study of the problem published in 2013 found 75% of the subjects who had participated in at least two trials in the previous year admitted concealing some important medical information:

  • 32% hid health problems
  • 28% concealed their use of prescribed medications
  • 20% failed to disclose their recreational drug use
  • 14% reported pretending to have a health condition in order to qualify.

Even when these professional study subjects have more altruistic motives, their deception can skew trial results. If enough of these types of study subjects manage to enroll – and the estimate is that as many as 25% of volunteers apply in a way that violates trial criteria – the results can be skewed.

Medscape says misrepresentation can be serious enough to “invalidate outcomes and even halt further research.”

Subject registries exist to attempt to catch the professional subjects. When detected, these individuals can be entered in a registry. Recently, these registries have begun to incorporate biometric data to foil the professional subjects who have used fake identification.

“That can sound very ‘Big Brother-ish’,” Devine says. “But think about the quality of our information — it can either be lifesaving or not. Do we really want to take a chance with medicine as a science, and leave it up to ‘Well, I hope we didn’t have too many professional subjects in this trial?’ “

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