Why Participate?

You’re busy. You’re sick. Why bother?

With the help of your doctor, weigh the benefits and risks.

Possible Benefits

For some people, the benefits to enrolling in a clinical trial may be the chance to get state-of-the-are treatment and specialized medical attention—usually at no extra cost. Some trials even pay for time spent, travel costs, or other trial-related expenses.

For others, participation in a clinical trial may be a chance to try new medicines, learn more about the disease, and have the personal satisfaction of helping science find answers on lupus and autoimmunity.

Possible Risks

The medicine being tested may not work. Side effects may be serious or unpleasant.

A health professional must explain the possible risks and side effect during the informed consent process.

Participant’s Rights

The US Food and Drug Administration has carefully written rules about what must be done to protect the safety and privacy of participants. According to federal regulation, every clinical trial must be approved and monitored by an Institutional Review Board (IRB). This independent committee of doctors, nurses, and others is charged with ensuring that the trial is ethical and that the rights of participants are properly protected.

Informed Consent

The very first activity when one is considering participation in a clinical trial is to read and discuss information about the study, experimental treatment, and methods used during the study. An informed consent form outlines all these important facts. You should have ample opportunity to read this form and ask questions. Once you fully understand the terms of the trial, you will be asked to sign the informed consent form.

What it Means to Be Part of a Placebo-Controlled Trial

Participants should keep in mind that they may be randomly assigned to the “control” group and get either a different dose of the “test” treatment, a placebo (dummy drug), or even a treatment that is already available and considered a standard therapy for the disease. The control groups experience is used to make comparisons with the treatment group. Talk to the clinical investigators about issues such as time and travel for involvement that might not include actual treatment. 

Smart Questions to Ask

If you are considering participating in a clinical trial:

Am I allowed to quit a trial before I have completed all steps?
You are entitled to withdraw from a study at any point without jeopardizing your future medical care. However, since enormous resources are required to perform studies, a potential participant must put a lot of thought into whether he or she wants to make the commitment.

How will trial researchers protect my confidentiality?
Investigators will never use your name in any published documents nor can they give out information that would identify you to outside sources. Although the FDA and other agencies can access your medical records for inspection, your medical information cannot be used for any other purpose.

Other Smart Questions to Ask

Will I be allowed to keep taking my other medicines?

Will this affect my ability to have children some day?

Will I be allowed to keep seeing my regular rheumatologist and other doctors?

Although every effort is made to make clinical trials as safe as possible, the trials that test new therapies are essentially experiments.