Diversity in clinical trials

Clinical trial participants are key to developing safe treatments that work well to prevent, diagnose and treat kidney disease. The participants in clinical trials should represent the diverse group of people who have the health problem being studied and will use the treatment out in the world. However, Black, Hispanic, Native American and Asian American people are often underrepresented in clinical trials. This means that compared to the number of people from these communities who are living with kidney disease, few participate in clinical trials. Learn more about why diversity in clinical trials is important and consider why you should take part in a clinical trial.

Why is it important for people of color to take part in kidney disease clinical trials?

Black, Hispanic, Native American and Asian American people have a greater chance of having kidney failure compared to white people. To make sure that treatments are safe and work for all people with kidney disease, it is important for clinical trials to include people from diverse backgrounds. Research has shown that people may have different reactions to treatments based on their race, ethnicity, gender, age and other factors. This is why it is important for clinical trial to include participants of different races, ethnicities, genders, and ages.

Currently, although people of color are more likely to have kidney failure, they are underrepresented in clinical trials. For example:

• More than 1 in 3 people (about 33%) with kidney failure are Black people. But only about 1 in 10 clinical trial participants (about 9%) are Black.
• Hispanic people are nearly 1.5 times more likely to have kidney failure compared to non-Hispanics. But, only about 1 in 10 clinical trial participants are Hispanic, while nearly 7 in 10 participants are non-Hispanic.  

How does taking part in a clinical trial help improve treatments for kidney disease?

Before a treatment can be approved for use with patients, researchers must first test it for many years in a clinical trial. Clinical trials need different types of participants:

• A healthy participant is someone who does not have the disease or health condition being studied
• A patient participant is someone with the disease or health condition being studied.

Through the four phases of a clinical trial, researchers answer the following questions by observing hundreds to thousands of volunteers:

• Is the treatment safe?
• How does treatment work in the human body?
• How much of the treatment is needed to have an effect?
• What is the best way to use the treatment?
• What are the possible risks and side effects of the treatment?
• Is the treatment better than already existing treatments?

After the new treatment is approved by the FDA, doctors can prescribe it to the public. This adds to the available treatment options for people living with kidney disease around the world. Clinical trials that test new treatments are just one type of clinical trial; there are many other types of clinical trials that need volunteers too.

Clinical trial participants play a key role in developing new ways to prevent, diagnose and treat kidney disease and learning more about rare diseases. For example:

• Clinical trials have led to new treatments to slow damage to the kidneys and prevent kidney failure and death. For example, the U.S. Food and Drug Administration (FDA) approved several new medicines to treat diabetes and protect kidney function.
• Clinical trials have led to better ways to prevent and diagnose kidney disease. For example, in 2019, the FDA approved a smartphone-based at-home urine test that people can use to test their urine for signs of kidney disease at home.

How can I get involved in clinical trials?

Before deciding whether taking part in a clinical trial is right for you, it is important to understand what clinical trials involve, including:

• What clinical trials are: Clinical trials are research studies that test new treatments in people. Before treatments can be approved to use with the public, they go through many phases of testing.
• What happens in clinical trials: During the trial, you will get care from a treatment team, including doctors, nurses and other health care providers. When the trial ends, the treatment team will look at the results. Learn more about what to expect during and after a clinical trial.
• Are they safe?: There are many safeguards in place to protect the people who take part in clinical trials. Learn more about safety in clinical trials.

Talk with your doctor about clinical trials you can sign up for

If you are thinking about joining a clinical trial, talk with your doctor. Your doctor can discuss your treatment options to help you decide if a clinical trial is right for you. You doctor can also help you find a clinical trial that you may qualify for as a healthy or patient volunteer.

Before you join a clinical trial, talk with the treatment team about your concerns and questions

Before you decide to join a clinical trial, learn as much as you can about it. Every clinical trial has a treatment team who is there to help you understand how the clinical trial works and what being in the trial will mean for you. From talking to the treatment team, you can learn more about:

• The purpose of the clinical trial: Treatment trials are research studies that test new treatments in people, but there are other types of clinical trials too. 
• What to expect during and after the trial: During the trial, you will get care from a treatment team, including doctors, nurses and other health care providers. You may also be asked to do certain tasks at home. What happens after the trial depends on the type of trial it is.
• Safety measures: By law, there are many safeguards in place to protect the people who take part in clinical trials.

Be sure to talk to the treatment team about all your concerns. The more you know about the trial, the more confident you can feel about making a decision about whether to join. When preparing a list of questions, consider asking:

• Will I have to travel to a clinical trial site? If so:
  • Will the trial provide transportation or pay for my travel costs?
  • Can I schedule my visits after work hours or on the weekends?
• Will I be paid for taking part? What costs will I have to pay?
• What are the possible risks and side effects?
• What are the possible benefits?
• How will my information be kept private?

Get a list of more questions to ask the treatment team. 

Spread the word about the importance of diversity in clinical trials

Share what you know about clinical trials with your family and friends, so they can consider if taking part in a clinical trial may be right for them. Researchers are looking for participants who have certain health problems and they are also looking for participants who do not have health problems (healthy volunteers). By spreading the word, you can help make sure that your community and people like you are represented. For example, share a link to AKF's clinical trials webpage , which includes a tool to find clinical trials you may qualify for.