Before joining an RA clinical trial, participants naturally have many questions. Bring this checklist to your next doctor’s appointment. Rheumatoid arthritis (RA) is a type of inflammatory arthritis in which the immune system malfunctions and attacks the synovium—the connective tissue lining your joints. RA can also affect other body parts, including the skin, eyes, and heart.The
Rheumatoid arthritis (RA) is a type of inflammatory arthritis in which the immune system malfunctions and attacks the synovium—the connective tissue lining your joints. RA can also affect other body parts, including the skin, eyes, and heart.
The exact cause of RA is unknown, but researchers think genetics and environmental factors might be to blame. Treatment options for RA include medication, lifestyle therapies, physical and occupational therapy, assistive devices, and surgery.
There is no cure for RA, but most people can manage symptoms for decades or most of their lives. An unfortunate smaller group, however, might experience severe disease symptoms and ongoing progression (RA that continues to get worse). They may experience damage to cartilage, bones, and joints, which can lead to bone-on-bone pain and severe pain and swelling of joints.
People with severe RA likely have tried different treatment options, and their RA continues to worsen. These treatments are costly.
In these cases, healthcare providers might recommend clinical trials to reduce treatment costs or to try a new treatment when effective treatment options have run out. Research shows clinical trials can be a cost-effective tool for bringing down healthcare expenses.
You don't have to have severe RA to enter a clinical trial. People with mild to moderate disease can also enter clinical trials and help researchers better understand RA and advance new RA medicines and treatment strategies.
The decision to enter a clinical trial is not an easy one. Fortunately, your healthcare provider can be a valuable resource. They can answer questions about RA trials and help you find one that could best help you.
This article will cover the benefits of entering a clinical trial for RA, the drawbacks, and questions to ask your provider.
A clinical trial is medical research conducted on people. RA studies might evaluate new drugs and treatment options, explore preventive therapies, or investigate surgical procedures. Goals in RA studies might be to learn more about the disease, a new medication, or a promising treatment strategy.
There are plenty of reasons you might want to participate in a clinical trial. Benefits of participating in an RA clinical trial might include:
Just as clinical trials have benefits, they also have drawbacks.
Disadvantages of participating in a clinical trial might include:
If you are thinking about taking part in a clinical trial, you should find out as much as you can about the study before you decide to participate. Your healthcare provider can answer many of these questions.
Questions on eligibility may include:
Safety questions include:
Questions on side effects include:
Questions on patient rights include:
The Food and Drug Administration (FDA) ensures all drugs marketed in the United States are safe and effective for human use.
The FDA considers treatments it has previously reviewed and assessed for risks standard treatments. Standard treatments are those available to benefit individual patients based on patient need assessments and guided by medical boards, state regulations, and more. They are covered by health insurance plans,
Experimental treatment is different from treatment your healthcare provider prescribes. According to the FDA, experimental treatments are intended to benefit future patients.
Clinical studies are paid for by drug manufacturers and government agencies. They require informed consent (a detailed communication process) and provide a periodic and systematic assessment of patient data. They are protected by review boards, professional and legal standards, government agencies, and informed consent legal guidelines.
When treating people with RA, healthcare providers rely on information from clinical trials and their experience in clinical care. However, these resources will differ because studies rely on a minority of candidates seen in medical practices, and assessment measures in clinical trials will vary from what is used in clinical practice.
During a clinical trial, researchers try to determine if new medicines, therapies, and strategies are safer and more effective than current treatments. The decision to enter a clinical trial is not an easy one.
If you are interested in learning more about clinical trials for rheumatoid arthritis, your healthcare provider can answer many of your questions. They might also have information about studies that might help you save money and better treat your RA.
They can also share information about the benefits and risks of a particular trial, the types of clinical trials available, eligibility, side effects, other safety information, treatment and testing, and your patient rights.
Clinical trials come with unknowns, which can cause people to be fearful and anxious with concerns about their privacy, care, and safety. You can ease your worries by getting a clear understanding of what an RA clinical trial might involve before you agree to participate.
Personal information gathered during a clinical trial is confidential and reported results will not have your name attached to them. Your care will be in the same places standard RA care is given—typically at rheumatology practices and clinics or another healthcare setting.
Clinical trial participants are closely monitored so the healthcare providers managing their care can quickly assess and address any side effects or adverse reactions.
If you and your healthcare provider determine the clinical trial is not benefiting you, you may quit the trial without penalty. Leaving the clinical trial will not affect your access to future RA treatments.
No. You should not have to pay any fees to be a part of an RA clinical trial. Most clinical trials offer study-related medications and medical exams at no cost to you. You might even be compensated for time and travel.
The length of a clinical trial will vary depending on the treatment being studied and the study’s phase. In general, the trial period increases with each phase. For example, phase 1 could last several months, phase 2 could last from several months to two years, and phase 3 could last anywhere from one year to three years.
You will want to consider certain factors before joining a clinical trial. First, you will want to better understand the goals of the project and the advantages and disadvantages of joining the clinical trial. You also will want to understand what is required of you and if you will be able to follow through.