Lupus Clinical Trials

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What Is a Clinical Trial?

Clinical trials are research studies that involve patients to answer specific questions about new treatments, or new ways of using known treatments. Carefully conducted clinical trials are the most valid way to determine whether new drugs, existing drugs used in new ways, or other treatments work, and are safe to use in people.

In clinical trials, one group receives an experimental drug while another group, the control group, gets standard treatment or an inactive treatment known as a placebo. Studies that include control groups are known as controlled trials.

The Four Phases of Clinical Trials

Testing of new or innovative ways to treat diseases often goes through four phases of development:

  • Phase I tests a new drug or treatment in a small group to see how the drug works in the human body, if there are side effects with increasing doses, and to gain early evidence the drug is effective.
  • Phase II tests the new drug or treatment in a controlled trial, with one group of patients getting the experimental drug and another group getting standard treatment, or a placebo. This phase is often aimed at figuring out the correct dose or way to give the drug or treatment.
  • Phase III tests the new drug or treatment in expanded controlled and uncontrolled trials to get additional information to evaluate the treatment's overall benefits and risks and to use for the medication label.
  • Phase IV continues to test the drug after it has been licensed and marketed to get more information on its risks, benefits and best ways to use it. Extensions of Phase IV trials test the drug in situations that are like how they will be used by patients in real life.

By participating in a clinical trial, you can gain access to new research treatments before they are widely available and help others by contributing to medical research. All clinical trials have guidelines and eligibility criteria designed to make sure the participants will be safe and the study will be valid and answer the research questions. Certain research studies are aimed at finding the cause, delivery, manifestations, and longer term outcomes of rheumatic diseases in children. 

To learn more about clinical trials, you may visit these websites: