- Clinical trials are carefully planned research studies. An institutional review board (IRB) must approve all clinical trials before a trial can start.
- Without clinical trials, no new medicines or therapies can be approved for use in people.
- All clinical trials must be fully explained to patients who want to take part. These patients must sign an informed consent form.
- Signing an informed consent form means you understand the risks involved with the clinical trial. The informed consent form is not a contract.
- If a new treatment works, you will be the first to benefit.
- The clinical trial treatment may not be better, or even as good as, the standard treatment.
- The clinical trial treatment may cause side effects. If doctors think a treatment is hurting you, the treatment will be stopped.
- Among clinical trial patients, 35% worry about the risks and side effects of the treatments they are testing.
- You have the right to ask the doctors any question about your treatment. If you do not like the answers they give you, do not take part in the trial.
- Some studies randomly assign patients to treatment groups. In these cases, you may not know which group you are in and who will get the new treatment, the standard treatment, or no treatment at all.
- Among clinical trial patients, 48% worry most about getting the placebo (no treatment).
- Clinical trials that are testing treatments for life-threatening diseases or conditions will rarely use a placebo group, meaning all patients will get some kind of treatment—either the new treatment or the standard treatment.
- Clinical trials take place in major medical centers, universities, community hospitals, clinics, doctors' offices, and veterans and military hospitals.
- Taking part in a clinical trial is always completely voluntary.
- You may quit a clinical trial at any time.
Sources: The National Institutes of Health, CenterWatch
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Updated October 2013