Leading the way to a cure

Lupus Clinical Trials

People Helping to Shape Science

As in all fields of scientific inquiry, lupus research has been greatly advanced by the pioneering studies of brilliant scientists — and the caring people who participate in clinical trials. In these studies, scientists and laypeople work together to find safer, more effective methods to diagnose, prevent, treat, and ultimately cure diseases.

Participating in a Clinical Trial

Those thinking about joining clinical trials often face a myriad of concerns — from basic questions, to those of a more complex nature: “What are clinical trials?” … “How do they work?” … “Are they safe?”… “Where can I obtain the information I need to make an informed decision?” While the Alliance for Lupus Research (ALR) does not monitor, substantiate, or endorse clinical trials, we recommend that anyone interested in joining a lupus trial should speak with their doctor first.

Click here to find a clinical trial near you

Clinical Trial Frequently Asked Questions

What are clinical trials and why are they so important?

Clinical trials are generally considered to be health-related research studies in human beings and one of the last steps in the development of a new drug or treatment for diseases like lupus. These studies are done to find out if the drug, therapy, procedure, or medical device is safe and effective for people to use — which must be determined before they can be made available to the public. This is why patient participation is so important. Recently, research has brought to light many promising avenues in the treatment of lupus — and a number of them are in clinical trial phases today. The people who participate in them are helping researchers develop better treatments and ultimately even find a cure for lupus. Clinical trials are usually orchestrated and sponsored by a government organization or a pharmaceutical or biotechnology company. From the development of new techniques to better diagnose the disease … to the creation of new therapies … to the lessening of harsh side effects — clinical trials are addressing lupus on many fronts.

How do clinical trials work?

Because patient safety is a paramount concern, drug approval can cost hundreds of millions of dollars and take decades to complete. The process is complex and is conducted in the following four phases:
  • Phase I determines safety and dosage.
  • Phase II evaluates effectiveness and safety levels.
  • Phase III involves many more patients and volunteers, allowing scientists to determine effectiveness for the general population.
  • Phase IV collects further information after FDA approval.

Are clinical trials safe?

Every precaution is taken to make trials as safe as possible. Even before patients can become involved in a clinical trial, satisfactory data must be compiled and presented to the Food and Drug Administration (FDA) for approval. Only after the FDA deems that the therapy is safe to test in humans, can a clinical trial begin. The researchers who conduct trials must work in accordance with strict rules set by the federal government. But clinical trials do not come without risks:
  • Treatment side effects could be mildly unpleasant to life threatening.
  • The treatment may not be effective.
  • The protocol (clinical trial procedures) may require more time and attention than a non-protocol treatment.

How are participants protected?

Participants in clinical trials are protected in several ways. Most clinical research is federally regulated and has built-in safeguards to protect the patient. Trials follow carefully controlled protocol — a plan that details what researchers will do in the study. An independent Data and Safety Monitoring Board follows the study closely for side effects and any unexpected outcomes. Once a trial is completed, researchers may report the results of the trial — but the names of participants remain confidential.

What is informed consent?

What is a protocol?

Protocols are plans on which trials are based. They also describe what types of people may participate in the trial, the schedule of tests, procedures, medications, dosages, and length of the study.;

Who sponsors trials?

Clinical trials can be funded by a variety of organizations, medical institutions, a pharmaceutical or biotechnology company, or a federal agency, such as the National Institutes of Health (NIH).

Why do people volunteer for clinical trials?

People who volunteer in clinical trials have the satisfaction of knowing that they are taking an active role in their health. Participants have access to a potential new treatment that may improve their conditions. Many view their involvement as a way of helping others — today and in the future.

Who is eligible to participate in a clinical tral?

A participant must qualify for the study and the criteria specific to the trial. Criteria is generally based on such factors as age, gender, the stage of the disease, previous treatment history, and other medical conditions.

What do I need to know before I decide to volunteer in a clinical trial?

The following is a list of questions that may be useful in helping you decide:
  • What is the study trying to find out?
  • What “phase” is the trial testing?
  • What kinds of tests might I have to take?
  • How much time is involved?
  • Will I be hospitalized?
  • What are the costs to me?
  • Who will pay if clinical trial funds don’t cover these costs?
  • What are my other treatment choices?
  • How do they compare with the treatment being studied?
  • What side effects, if any, can I expect?
  • How long will the trial last?
  • If I change my mind about participating, can I leave the trial when I want?

Corporations, CRO’s and Investigators if you have clinical trials that you would like the ALR to post information on please click here for more information.

1.5 million

people in the U.S. have Lupus.

172 million

dollars committed to lupus research by the Lupus Research Alliance.

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