About Lupus

Why Should You Care About Clinical Trials?

If you or someone you care about has lupus, you know how badly new drugs for lupus are needed. Researchers, doctors, drug companies, and others are working on this. To test whether they have identified a drug that is safe and will work, they run what is called a "clinical trial," in which people with lupus try it out.

Why take part in a clinical trial?
A person enrolled in a clinical trial usually gets several positive things out of the experience, such as expert care by the doctors and nurses who are helping to run the trial, and a chance to try out a treatment before it is widely available.

Many people who take part in a clinical trial also say that it makes them feel really good to give researchers a chance to learn so much. Without enough people in clinical trials, it's very unlikely that new drugs and better ways of preventing and caring for lupus will come about.

Who can participate in a clinical trial?
Very carefully written guidelines say who can participate. Depending on the trial's goal, there may be rules about such things as age, severity of lupus, treatment history, and the presence of other health conditions. The purpose of these rules is to let the researchers safely and efficiently answer the questions that the trial is designed to answer. Also, strict rules protect the health and privacy of participants.

Are there different types of clinical trials for lupus?
There are several, each with a different overall purpose.

  • Treatment trials test new treatments or drug combinations.
  • Prevention trials look for better ways to prevent flares or even stop lupus from developing in people who have never had it. All sorts of things—medicines, vitamins, vaccines, minerals, lifestyle changes—are tested in these kinds of trials.
  • "Diagnostic" trials and "Screening" trials aim to find better tests for diagnosing or detecting lupus (or flares) before serious damage is done.
  • Quality of Life trials search for ways to improve the comfort and quality of life for people with lupus.

What happens in a clinical trial?
This depends partly on what type of trial is being done. A treatment trial on a new drug is done in stages, for example, with studies for safety and effectiveness done in labs and animals before people are involved in any way. All treatment trials go through "Phases" that involve increasingly larger numbers of people.

What happens to a person in a clinical trial?
At the beginning of a trial, a team that includes doctors, nurses, and social workers check the person's health and give instructions on what is involved in participating.
During the trail and even after it ends, the team watches the participant carefully through many visits.

What risks are involved?
By law, the team must carefully explain all the possible known outcomes. The treatment may not work well, for example, or may cause unpleasant or even serious side effects. Involvement may also require many trips to the study site, hospital stays, or more treatments.

How can you find a clinical trial?