Lupus Clinical Trials
Overview
What is a Clinical Trial?
Quick Facts from Dr. Ann Clark
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Inclusion and exclusion criteria are in place to keep participants safe, not to reject them personally.
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Types of lupus trials: treatment (most common), prevention, diagnostic, and screening.
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Placebo in lupus trials: always added to your usual treatment, never replaces it.
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Extra benefits: care from lupus specialists and access to advanced testing not always available in routine care.
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Safety and confidentiality: federally regulated, with strict safeguards and guaranteed anonymity.
Watch: Understanding Lupus Clinical Trials
In this short video, Dr. Ann Clark explains what lupus clinical trials are, who can participate, the benefits and risks, and how safety is protected throughout the process.
Enrolling In a Clinical Trial
You may decide to participate in a clinical trial for the personal satisfaction that comes from being part of scientific research. Participating in a clinical research trial is very much like a regular doctor’s visit but usually involves extra time commitment and/or extra testing (for example, providing more blood or urine samples than usual).
Before You Enroll
Before enrolling in any clinical trial, you will be provided with an informed consent document, which you should read carefully. The consent form explains the purpose of the trial, the possible risks and benefits of treatment, and all the procedures involved in the trial. Your witnessed signature is required. It is important that any questions or concerns you have about the research trial are addressed to your satisfaction before you sign the consent form.
Risks & Benefits
Research trials have risks and benefits. It is possible that the treatment could improve your health or quality of life, but there may be side effects, which can vary from person to person. Be sure to read about them in the consent form.
Clinical trial participants also have responsibilities, which you must understand before beginning. You need to attend all your appointments, follow instructions carefully, and take medications exactly as prescribed. All of these are vital if the information from the trial is to be valid.
Deciding to participate in a clinical trial is your decision. Even after signing the consent form, you don’t have to continue if you feel uncomfortable about it. You have the right to leave the study at any time.
8 Questions: To Ask About A Clinical Trial
- What is the main purpose of this study?
- How will the study affect my daily life?
- Can I continue to take my usual prescription or over-the-counter medications?
- How many office visits are required, and how long does each take?
- What kind of medication is involved, and is there a chance I will get a placebo (a product with no active medicinal ingredients) instead?
- What type of procedures are involved (e.g., blood tests, x-rays)?
- What are the possible benefits?
- What are the possible risks and side effects?