Diversity and Lupus Clinical Trials: A Conversation with RADM Collins
Health Equity Forum Podcast: Episode 6 Transcript
RADM Araojo: Hello, and welcome to the Health Equity Forum Podcast, hosted by the FDA Office of Minority Health and Health Equity. I'm your host, Rear Admiral Richardae Araojo, the associate commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at FDA. In this episode, we'll be talking about participation in lupus clinical trials. Lupus is a chronic auto-immune disease, which means your body starts to attack its own tissues and organs. Lupus can cause inflammation in the body, causing damage to many parts of the body, such as the kidneys, joints, brain, heart, and lungs, for example.
Given that many of the symptoms mimic other diseases, lupus can be very hard to diagnose and currently there are limited treatment options. About nine in 10 people living with lupus are women, and it's more common in African-American, Asian, Hispanic Latina, and American Indian and Alaska native women. African-American women are three times more likely to get lupus than white women. And while 90% of people living with lupus are women, men are also diagnosed with lupus and may experience more severe symptoms than women. Given the limited treatment options and the disproportionate impact on racial and ethnic minorities, we must raise awareness about the importance of racial and ethnic diversity in clinical trials for lupus. Racial and ethnic diversity in lupus clinical trials is needed to ensure the development of effective treatments for all people living with lupus.
Joining me today to discuss the importance of diversity in lupus clinical trials is Rear Admiral Felicia Collins, the Deputy Assistant Secretary for Minority Health and Director of the Office of Minority Health and the Department of Health and Human services. Welcome to the Health Equity Forum Podcast, Rear Admiral Collins.
RADM Collins: Thanks for having me Rear Admiral Araojo.
RADM Araojo: First, tell me a little about what the Department of Health and Human Services Office of Minority Health does.
RADM Collins: The mission of the Office of Minority Health is to improve the health of racial and ethnic minority populations through the development of health policies and programs that will help eliminate health disparities. We currently have four programmatic priorities. First, supporting states, territories and tribes in identifying and sustaining health equity promoting policies, programs, and practices. Second, expanding the utilization of community health workers to address health and social service needs within communities of color. Third, strengthening cultural competence among healthcare providers throughout the country. And lastly, supporting the COVID-19 response and recovery within racial and ethnic minority and American Indian and Alaska native communities. One of our strategies for eliminating racial and ethnic health disparities is to support diversity and clinical trials. Lupus is a specific area for which we fund grant programs to identify the best practices for training, outreach and clinical trial education to improve clinical trial diversity and thus help reduce health disparities.
RADM Araojo: And our offices share a particular interest in lupus because it's a disease that disproportionately affects racial and ethnic minority populations.
RADM Collins: Yes we do. As you mentioned, lupus is more common among black, Asian, Hispanic Latina, and American Indian and Alaska native women than white women, but it also affects men. African-American and Hispanic Latino women are diagnosed with lupus at a younger age and have more severe symptoms than women of other groups. Black people living with lupus also have higher rates of death from lupus and die at a younger age than white people living with the same condition.
RADM Araojo: Our offices also share a concern that participants in lupus clinical trials may not always reflect the diversity of people living with the condition. Clinical trials are research studies involving human volunteers to evaluate medical products like medications, vaccines, or devices for safety and effectiveness. These studies may also show which medical products or therapies work best for people with certain illnesses, for certain groups of people.
RADM Collins: It's wonderful that advances in the understanding and treatment of lupus over the last several decades have resulted in people with the disease living longer. However, there still are only a limited number of FDA approved treatments available. More research needs to be done to develop new therapies that control lupus symptoms or bring about remission of the diseases that are linked with lupus or play a role in its development.
RADM Araojo: And this is why it's important that members of racial and ethnic minority groups and American Indian and Alaska native people join clinical trials. We know that there are biological differences in how people process drugs, which is why we need more diverse groups to participate in clinical trials, so we can study the different responses to treatment. We need appropriate representation to have relevant data on the effectiveness, safety and side effects of lupus treatments within populations who are most effected. Rear Admiral Collins, what are some of the pros and cons of participating in a clinical trial?
RADM Collins: Joining a clinical trial might be a good choice for people living with lupus. First of all, a clinical trial may provide another option when standard treatments have failed, although it is important to remember the investigational medical product is not a treatment. Also, many patients desire to aid future generations by helping researchers find better ways to fight clinical conditions like lupus.
However, no clinical trial is without risks. The medical product being tested may be new, so it may not be effective. And you may have side effects that the healthcare provider does not expect. Now that can sound scary, but it's important to note that clinical trial participants are always told who to contact if there's an emergency. In addition, the study will be stopped if significant safety concerns emerge during the trial. Also, there are no guarantees that the therapy will work or that you will be assigned to the group of participants who received the therapy under study. You may instead be assigned to a comparison group that receives another therapy or receives a placebo. So it is very important to acknowledge and understand the risks of clinical trial participation. And for many, the potential benefits of clinical trial participation can outweigh those risks.
RADM Araojo: Listeners should understand that the safety of clinical trial participants is a priority. Researchers must follow detailed protocols and the FDA safety requirements to make each trial as safe as possible. Also, you can leave the study at any time for any reason without penalty. Your health and wellbeing are a priority.
RADM Collins: That's right. Before you volunteer, the research team is required by law to give you the important facts about the trial. This is known as informed consent. They will tell you everything you need to know and answer your questions so you can decide whether or not you would like to participate. If you agree and want to move forward, you will be asked to sign an informed consent form to show that you agree to participate in the trial and fully understand your rights, in addition to the benefits and risks. And, as you mentioned, participants should always know that at any point in time, they can stop their participation in the trial without penalty or consequences.
RADM Araojo: Admiral Collins, what are some reasons people provide for not participating in clinical trials?
RADM Collins: Now many diverse individuals have concerns about joining a clinical trial or face limitations that make them less likely to participate. For instance, it may be difficult for some to take off time from work or to secure childcare, and others may not have resources to find transportation to get to the trial site. Others simply may not know that there are open trials that they could participate in that are close to where they live. Some individuals in the U S may not trust medical research due to historical mistreatment of those involved in research, such as those involved in the Tuskegee study.
However, it's vital to point out that those past historical abuses led to major changes in how clinical trials are conducted to protect the rights, safety, and welfare of those participating in the trials. Today's participants rights are protected by law and by ethics committees known as Institutional Review Boards or IRBs, which carefully review plans for new clinical trials at least once a year. I should also add that in some areas, many patients are not offered the opportunity to participate in the study. Therefore, I encourage your listeners to talk with their clinical providers and ask about opportunities to join a lupus or other clinical trial.
RADM Araojo: I want to share with our listeners, some of the questions they should ask about participating in a clinical trial. It is important that you talk with your healthcare provider about whether joining a trial is a good idea based on your current treatment. If your healthcare provider thinks it's a good option, then you may want to ask the following questions to the members of the team conducting the trial. What happens during the trial? What kinds of tests and drugs are involved? What are the benefits and risks? What are the possible side effects? How often will I need to travel to, or stay at a clinic? Are there any costs involved? How will my personal information be protected?
Additionally, our office has developed resources for patients to help make informed decisions, like our questions to ask before joining a clinical trial handout, and our clinical trials brochure and fact sheet, to educate patients on the clinical trial process so they know what to expect. I encourage patients to ask as many questions as possible so they can make the best decision for themselves. I hope this conversation encourages people living with lupus, especially those from diverse racial and ethnic backgrounds, to consider learning more about clinical trials and determining if joining a clinical trial is right for them. Admiral Collins, can you share with our listeners where they can find additional information on clinical trials?
RADM Collins: Of course. Always start by consulting with your primary healthcare provider who can help guide you to clinical trial opportunities. In some cases, your provider may be aware of specific clinical trials that you may be eligible for. You can also search for clinical trials in your area at clinicaltrials.gov. Clinicaltrials.gov is a comprehensive website that houses information about many clinical trials in the United States. Information on the website is required to be updated by the sponsor or investigator conducting the research study. This information includes the description of the study, what will happen during the study, who is eligible to participate, where the study is located and contact information.
RADM Araojo: Thank you, Admiral Collins. Finally, please tell our listeners about our joint campaign to encourage people living with lupus who are members of racial and ethnic minority groups to consider joining a clinical trial?
RADM Collins: Sure. Let's Take Charge is our public education and outreach campaign that aims to provide information about clinical trials to diverse patients living with lupus and their caregivers. We've developed a dedicated website at minorityhealth.hhs.gov/letstakecharge, that has information about the benefits of joining clinical trials, webinars about lupus clinical trials and other educational materials. Most importantly, we have collaborated with patients living with lupus who have shared their real life accounts of what it's like living with lupus and being a part of a clinical trial. I hope your listeners check it out for all the great information located at minorityhealth.hhs.gov/letstakecharge.
RADM Araojo: Admiral Collins, thank you again for discussing clinical trials for people living with lupus and sharing information about this important campaign Let's Take Charge.
RADM Collins: Thank you. It was my pleasure to join you and your listeners.
RADM Araojo: For more about the Health Equity Forum Podcast series, visit our website - www.fda.gov/healthequity. While you are there, check out our library of resources and sign up for our newsletter. Also, don't forget to follow us on Twitter @FDAHealthEquity. Remember, together we can create a world where health equity is a reality for all.
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