Clinical Trials for Autoimmune Disease: Why They Matter

The treatments available today for autoimmune conditions exist because of people like you who participated in a clinical trial. New discoveries happen daily, but they only reach the market because of the people who chose to help others. There are many reasons to participate in clinical trials for autoimmune disease, but someone did—and because of that decision, we are learning more, developing more effective treatments, and getting closer to a cure.

What Is a Clinical Trial?

The National Institutes of Health (NIH) defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or other control) to evaluate the effects on health-related biomedical or behavioral outcomes.” It’s not just about drugs, although those are an important aspect, but also about interventions that help improve outcomes and quality of life for patients.

What Does a Trial Involve?

Participation varies, but most people gain access to a team of specialists dedicated to evaluating their condition and the impact of a specific treatment or modification. This involvement can help you learn more about your condition, potentially benefiting your overall health.

Phases of Clinical Trials:

• Phase 1 trials test an experimental drug or device on a small group of people (around 20 to 80) to judge its safety, including any side effects, and to test the dosage
•  Phase 2 trials include more people (around 100 to 300) to help determine whether a drug is effective. This phase aims to obtain preliminary data on whether the drug or device actually works as it is intended
•  Phase 3 trials gather additional information from several hundred to a few thousand people about safety and effectiveness, studying different populations and different dosages, and comparing the intervention with other drugs or treatment approaches
•  Phase 4 trials take place after the U.S. Food and Drug Administration (FDA) approves the drug or device. The treatment’s effectiveness and safety are monitored in large, diverse populations. Sometimes, side effects may not become clear until more people have used the drug or device over a longer period of time, and extensive data analysis is important to help inform the researchers on final patient recommendations.

The Importance of Diversity in Clinical Trials

For many years, most clinical trials and medical research was conducted primarily on White males with the assumption that the male perspective represents the norm. We know that is not the case. This assumption is inaccurate and not inclusive of different genders, ethnicities, socioeconomic groups, and races, who may respond differently to various interventions. Without diverse testing, it’s challenging for researchers to understand what works, what doesn’t, and for whom.

To achieve true health equity, it’s essential for communities of color to be represented in developing solutions. This includes considering socioeconomic status, as representation should be inclusive on a global scale. The more diverse the participants, the more likely medical interventions will be effective for people who share similar characteristics. It’s also crucial that individuals disproportionately affected by certain diseases are given a greater voice. For instance, lupus is more prevalent among African American, Hispanic/Latina, and Asian women, while alopecia areata affects Native Americans more frequently than other racial groups. Ensuring that those most impacted by these conditions are reflected in treatment approaches is vital to creating solutions that benefit everyone.

Why Participate in Clinical Trials for Autoimmune Disease?

There are many reasons that people decide to participate in clinical trials. For some, especially those with rare diseases, it may be the best option they have for any treatment. Others are motivated to making a contribution to the advancement of scientific knowledge. Additional reasons include:

• Access – Many clinical trials involve close monitoring of the condition, providing access to specialists and tests that offer medical insights beyond what is typically included in regular healthcare. Access to state-of-the-art care can be incredibly valuable in helping you understand your disease better.
• Scientific Knowledge – By participating in research, you play a vital role in advancing future cures and treatments. Your personal involvement not only benefits future generations of patients but also deepens the understanding of your condition and how it affects people like you. This is a meaningful contribution that ensures your voice is included in scientific progress.
• First-in-line treatment – For many participants, joining a clinical trial offers access to the latest breakthroughs in treatments and procedures that are not yet available to the public. With new and promising discoveries being made every day, clinical trials provide a unique opportunity to benefit from cutting-edge medications and procedures.

How to Get Started

To participate, speak with your healthcare provider or visit autoimmune.org.

Before committing, ensure you understand the trial’s purpose, eligibility requirements, commitment, travel, and other factors. Some trials require health insurance, while others are free or provide compensation. Clarify any penalties for withdrawing and understand the time commitment and site visit frequency.

Overcoming Barriers to Participation

Barriers to diverse participation in clinical trials still exist, but one way to overcome hesitation in your community is by sharing your story to help dispel misconceptions. Being open about your experiences—both positive and negative—can help others understand how your participation benefits both science and your health. This openness can reassure others about the safety and effectiveness of clinical trials and may inspire them to participate as well.

You don’t have to be ill to contribute—healthy volunteers are also essential to advancing science. Anyone who is eligible can make a difference by enrolling in a clinical trial. Your involvement benefits the entire community.

Stay Informed

 Discover more about clinical trials for autoimmune disease, explore available resources, understand the importance of diverse participation, and find current autoimmune clinical trials by visiting autoimmune.org/research/clinical-trials/.