DiversityNursing Blog

Increasing Diversity in Clinical Trials

Posted by Erica Bettencourt

Mon, Sep 14, 2020 @ 09:51 AM

diversepopClinical trials are necessary to provide evidence for the benefits and safety of new treatments. Racial and ethnic minorities continue to be underrepresented in these clinical trials.

Black or African Americans represent 13.4% of the U.S. population, yet reports show they make up only 5% of clinical trial participants. Hispanic or Latino origin represent 18.1% of the U.S. population but only 1% of clinical trial participants.

The clinical trial population must be diverse enough to represent the patients who will be using the medicine.

According to a ScienceDirect study, Inclusion of diverse participants in clinical research may lead to more robust and complete data that broadens the understanding of racial and ethnic differences in treatment responses that, in turn, may contribute to reduced disparities in outcomes.

Richardae Araojo, who is the FDA Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity said, “There are many different reasons why minorities have been under-represented in clinical trials. One barrier to participation that we all know well is a lack of trust because of past historical abuses. Other barriers to participation may differ based on the population you are seeking to enroll and may include language and cultural differences, health literacy, religion, and a lack of awareness and knowledge about what a clinical trial is and what it means to participate.”

Araojo continued by saying “Some barriers may be due to aspects of the trial design such as inadequate recruitment and retention efforts, accessibility to the site location, frequency of study visits, transportation, participation may conflict with caregiver or family responsibilities, and may cause time away from jobs and other commitments. Often times, there may be a perception that minorities do not want to participate, and they simply aren’t asked.”

Recently, the National Institutes of Health launched the All of Us Research Program. This program is inviting one million people across the U.S. to help build one of the most diverse health databases in history.

The All of Us Research Program is a great example of inclusive research that can help ensure better health outcomes for all.

The Food and Drug Administration (FDA) released a draft guidance on improving the diversity of patient populations in clinical trials.

The draft makes numerous recommendations on how to increase diversity in clinical trials. These recommendations include enrichment, inclusive trial practices and design, and methodological ways to bring in a wider range of patient populations.

The benefits of increased diversity in clinical trials are enormous. Enrolling diverse patients in clinical trials improves the likelihood that they will benefit from research data. Trial results will be more represented and relevant for the entire population.

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Topics: clinical trial, diverse clinical trials, increasing diversity in clinical trials

Georgia Boy Among First To Receive Experimental Medical Marijuana Drug

Posted by Erica Bettencourt

Fri, Jan 02, 2015 @ 11:36 AM

By LIZ NEPORENT

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A 7-year-old boy is one of the first people in the country to receive a potent form of medical marijuana as part of an “extended use” clinical trial to reduce seizures.

Preston Weaver, who lives in Athens, Georgia, has Lennox-Gastaut syndrome which is a severe form of epilepsy. He experiences up to 100 seizures a day, although many are confined to his brain and aren’t noticeable to an observer. There is no known cure for the condition.

“Today’s the day, buddy. We’re not going to have any more of those,” his mom Valarie Weaver, 36, said she told her son as the headed to his first treatment Tuesday.

Her son can't see, walk or talk, Weaver said. Although he's 7, his behavior is more like that of a 2-month-old. But he lights up when he goes in the water and he seems to love the feel of the sun and the wind, Weaver said.

"Our hope is that this treatment will calm down his brain enough so that he will start communicating with us," she said.

Many of the drugs available to treat the syndrome don’t work long term, especially for children. Even with more than a dozen medications Weaver has had no relief.

The active ingredient in Epidiolex, the experimental drug that Weaver and one other child are receiving, is called cannabidiol. It’s also the main active ingredient in marijuana though it doesn’t produce a high.

Dr. Michael Diamond, the interim senior vice president of research for Georgia Regent University said the drug is not legal or approved for use by use by the Food and Drug Administration. The university’s current study, one of only a handful of trials for compassionate use being held around the country, will expand to include 50 children over the next few weeks.

“We are hopeful the drug will reduce the frequency and severity of seizures within a month, but we know it will not work for every child,” he said.

Georgia Gov. Nathan Deal approved the trials in April. It took some time to get additional clearance at the federal level, Diamond said.

“No one with a heart could hear the stories of these children and their parents and not want to exhaust every possibility to provide them with the treatment they need to combat this debilitating condition,” said Deal

Weaver told ABC News that she was grateful her son was accepted into the trial though she was disappointed the state legislature had narrowly failed to pass a bill that would have legalized the drug for use with sick children. But, she said, she’s not giving up.

"Even though Preston is on it, Preston and I are still going to fight for all the other ones too, we will be at the capital every single time, we need to be there until this becomes legal and every child in the state has the option for this treatment if they need it," Weaver said.

Source: http://abcnews.go.com

Topics: clinical trial, marijuana, medical marijuana, health, healthcare, nurses, doctors, Epilepsy, patient, treatment

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