Difficulty in determining whether a drug or treatment approach that seems effective in the laboratory or in animals is also effective—and safe—in human beings.
Every clinical trial has “inclusion” and “exclusion” criteria that determine who is eligible to participate. These criteria are determined before a trial begins enrolling participants.
Inclusion criteria are characteristics you must have to participate in the trial.
Exclusion criteria are characteristics you cannot have to participate in the trial.
Examples of criteria that are sometimes considered include gender, age, lupus complications and/or medications.
What is a Clinical Trial?
Clinical trials help to answer the question, "Will this drug help people and be safe to take?"
At any given time, there are thousands of clinical trials going on. In the past several years, increasing numbers of lupus clinical trials have started up.
Clinical trials are critical in the search for a better life for people with lupus.
Clinical trials usually are done after laboratory or animal research suggests that the drug might work. If the trials are successful, the drug may be made widely available to the public as a prescription medicine.
The steps—called “phases”—of a clinical trial are clearly mapped out and carefully regulated by the FDA. These studies in human beings can only start once preclinical work is complete and the safety in animals is established.
PHASE 1: Evaluating safety and establishing the proper dose are the main objectives of these early studies, which a relatively small number of volunteers—usually 20 to 100—participate. Sometimes these studies are performed overnight in hospitals.
PHASE 2: Although evaluating safety remains a priority, phase 2 studies determine whether the experimental therapy is effective. These studies are typically performed in 100–400 subjects.
PHASE 3: The advantages of the treatment in development as compared to existing treatments are determined in up to 3,000 volunteers. Phase 3 testing must be completed in order for the FDA to approve the treatment.
PHASE 4: After the drug has been approved, information on long-term side effects and effectiveness is obtained in phase 4, or “post-marketing,” studies.
Trial Terms to Know
What “Randomized” Means
If you enroll in a “randomized” clinical trial, you will be randomly assigned to a treatment or to a control group that gets a placebo (inactive treatment).
What “Double-Blind” Means
If a study is “double-blind” neither the participant nor the people conducting the trial know which group you have been assigned to—the one with the test drug or the placebo (inactive treatment).
What “Placebo-Controlled” Means
The purpose of the placebo-control group is to better assess the good and bad effects of the experimental treatment.
