Increasing Diversity in Clinical Trials

Latinos are one and a half times more likely to develop Alzheimer’s and other dementias compared to white Americans. And older African Americans are approximately twice as likely to have Alzheimer’s and other dementia as older white Americans.





Yet, when it comes to clinical trials for dementia and other diseases and conditions, there is a lack of diversity, and minorities like Latinos and African Americans are underrepresented.

In 1993, the National Institutes of Health (NIH) addressed the lack of diversity by adopting a policy requiring federally funded clinical research to include women and minorities. Twenty-seven years later, participants of clinical trials today still lack ethnic diversity, although there is some progress with an increase in female participation.

The Importance of Diversity in Clinical Trials

According to the U.S. Food and Drug Administration (FDA), diversity in research is crucial to ensure the safety and effectiveness of drugs and medical products for all groups of people­. And as previously referenced, groups at higher risk for dementia and other diseases will eventually become the patients consuming the approved drug/medical product, thereby reinforcing the need for their inclusion in trials.

In 2010, the U.S. Census Bureau indicated 20 percent of the U.S. population ages 65 and older identified as a racial or ethnic minority. It is projected that by 2050, 42 percent of American older adults will be members of minority groups. Among those ages 85 and older, 33 percent are projected to be a minority. As the population of minority groups continues to grow, it underlines the importance for representation in all phases of research.

The Race to Find a Cure for Dementia

More than 5 million Americans are living with Alzheimer’s, and that number is expected to increase to 14 million in 2050. According to the World Health Organization, it is estimated that 50 million are living with dementia globally, and estimated to almost triple in 2050.

Currently, there is no cure or treatment for dementia. The projected statistics are staggering and will have implications on increasing healthcare costs, and of course, on the wellbeing of the aging population. As such, the race is on to end Alzheimer’s and dementia.

The National Institute on Aging (NIA) presently supports more than 230 active clinical trials on Alzheimer’s and dementia. These clinical trials are crucial in developing ways to prevent, diagnose, and treat dementia as well as to improve the quality of life for patients with dementia.

Volunteer participants are essential to trials and there is a dire need for them. “Our funding has ramped up dramatically, which means there’s more overall research and more clinical trials, and we need more people with dementia to participate,” says Nina Silverberg, director of the Alzheimer’s Disease Research Centers Program at the NIA. To foster greater recruitment in clinical trials, NIH Health is researching how to make it easier for people to participate.

The Obstacle: Recruiting Participants

It is already a challenge for researchers to find eligible participants for trials, let alone ensure diversity in the pool. While there are several other challenges associated with clinical trials, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), recruiting and retaining clinical trial participants is “currently the greatest obstacle to developing new Alzheimer’s treatments.”

Selecting the right participants can be arduous, time-consuming, and costly. It is estimated researchers need to screen 10 people to identify an eligible participant. “The major obstacle for getting admitted into a trial is the individual not fitting the necessary inclusion and exclusion criteria,” said Douglas Scharre, M.D., director of the division of cognitive neurology at the Ohio State University Wexner Medical Center.

Increasing Diversity in Research

Recent efforts to move the needle on diversity in research are encouraging:

  • In 2018, the National Institute on Aging (NIA) announced its National Strategy for Recruitment and Participation in Alzheimer’s and Related Dementias Clinical Research to help engage and recruit more diverse groups of participants for clinical trials.
  • In that same year, the NIH launched the All of Us Research Program to collect and study data from one million or more people living in the United States; enrollment is expected to last at least 10 years. With a commitment to recruit a diverse participant pool that includes members of groups who have been left out of research in the past, the All of Us goal is to help researchers increase their understanding of why people get sick or stay healthy.
  • The FDA called for increased participation and diversity in clinical trials, offering guidance for researchers and recommendations for the collection of race and ethnicity data.
  • Boston University and Savonix teamed up in 2019 for the Assist Study, a three-year study to look at brain health and related lifestyle factors (e.g., diet, sleep, exercise) of about 400,000 participants. Past Alzheimer’s disease or dementia studies have focused on only a few hundred people and mainly on non-Latino white participants. The Assist Study is the first scale of its kind. It will use the Savonix Mobile platform to gather data from hundreds of thousands of people and focus on more diverse groups. The Assist Study will help scientists develop new medicines and therapies, bringing us closer to finding a cure for Alzheimer’s and dementia. For more information, visit assiststudy.org.

How Savonix Advances Cognitive Research and Helps Diversify Participants

While the industry faces barriers to recruit eligible participants, Savonix provides the solutions. We partner with researchers to overcome the challenges of finding the right participant for the right trial.

As a global leader on cognitive health, Savonix has a growing database of 50 million data points that provide insights into cognition. Researchers can leverage our cognitive data categorized by age, gender, race, education, and more. And, if a diverse pool of participants is what researchers need, we can provide access too. We save researchers time in enrolling participants and decrease research costs in their trials.

Savonix digital cognitive assessments can be taken on any mobile device, reaching a larger population of people than traditional pen and paper tests. Savonix tests have a 98 percent completion rate, are accurate, reliable, and assess brain function across more than 12 cognitive domains including memory, attention, and focus.

To learn more about how Savonix helps researchers, read our case study.


References

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https://www.brightfocus.org/alzheimers/information
https://www.usagainstalzheimers.org/networks/latinos