Clinical Trials
Fast Facts
- Clinical trials test safety and effectiveness of new treatments or new ways to use existing therapies.
- Participation in a clinical trial is voluntary and depends on the possible benefits and risks associated with a particular trial.
- Before any of these medicines can be prescribed, the federal Food and Drug Administration (FDA) has required strict testing through a clinical trial to be sure they are safe and effective at treating a particular disease.
What Is a Clinical Trial?
A clinical trial is a research study performed by physicians, scientists, and other healthcare professionals in which new treatments are tested on volunteers. These studies begin only after laboratory and early research studies suggest that a treatment may be effective and safe. Before volunteers can participate, an institutional review board (IRB) reviews and approves each study to help ensure participant safety and that federal regulations protecting human subjects are followed. Participants must understand the possible benefits and risks of the study and sign an informed consent form before enrollment.
During a clinical trial, patients with conditions such as rheumatoid arthritis may receive a new medication, an existing treatment, or sometimes a placebo (inactive treatment), depending on the study design. Participants are monitored closely throughout the study. Doctors and research staff regularly evaluate how well the treatment works, monitor disease activity, and watch for side effects or other safety concerns.
Participation in a clinical trial is completely voluntary. Participants may leave a study at any time and for any reason. Leaving a study will not affect their regular medical care or relationship with their healthcare providers.
What Are the Benefits and Risks of Participation?
Benefits of participating in a clinical trial include:
- Access to new and potentially more effective treatments before they are widely available
- Close medical monitoring by healthcare professionals and research staff
- Many clinical trials provide study medications, doctor visits, laboratory testing, and other study-related care at no cost
- The opportunity to help advance medical knowledge and improve future treatments for people with similar conditions
Possible risks of participation include:
- Some participants may receive a placebo rather than the study medication, depending on the study design. In many trials, participants and study staff are “blinded,” meaning they do not know which treatment is being given. Participants are also usually “randomized,” meaning assignment to a treatment group occurs by chance.
- Study medications may cause side effects or unexpected risks. Because investigational treatments are still being studied, less may be known about their long-term safety and effectiveness compared with approved therapies.
- Participation may require additional clinic visits, laboratory testing, or time commitments.
Talk with your rheumatologist about clinical trials and whether they are right for you. You can learn about clinical trials on the website clinicaltrials.gov.
Updated May 2026 by Howard Yang, MD, RhMSUS, and reviewed by the American College of Rheumatology Committee on Communications and Marketing.
This information is provided for general education only. Individuals should consult a qualified health care provider for professional medical advice, diagnosis, and treatment of a medical or health condition.