Lupus Foundation of America Inc.

about clinical trials

Clinical trials are studies that evaluate the safety and effectiveness of new drugs or treatment strategies. The development of more effective lupus treatments requires that new and innovative therapies be evaluated. The development of new, safer, and more tolerable treatments for lupus is critical. This is not possible without clinical research. Yet, without clinical trial participants, these studies cannot be completed. It is very important for people living with lupus to understand the process and make an informed decision about participation in clinical research.

Choosing to participate in a clinical trial is an important personal decision. In addition to gathering information from our Center, it is often helpful to talk to a physician, family member, or friend about deciding to join a trial. If joining a trial is right for you, the next step is to identify trial options, contact the trial’s research staff and ask questions about specific trials. Learn more about participating in clinical trials.

Frequently Asked Questions about Clinical Trials

• What is a clinical trial?

• What is a clinical trial?

  • Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in people that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the participant volunteers are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

• Why participate in a clinical trial?

• Why participate in a clinical trial?

  • Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

• What are the different types of clinical trials?

• What are the different types of clinical trials?

  • • Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
    • Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
    • Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
    • Screening trials test the best way to detect certain diseases or health conditions.
    • Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

• What are the phases of clinical trials?

• What are the phases of clinical trials?

  • Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

    • In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
    • In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
    • In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
    • In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

• Who sponsors clinical trials?

• Who sponsors clinical trials?

  • Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veterans Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.

• How can you find specific clinical trials?