How do clinical trials work? continued...
After you are accepted by the clinical trial and you give your consent to take part:
- You will be given a structured program to follow.
- You will have a schedule of tests, doctor appointments, and treatments.
- You may be asked to keep a diary of your experience during this time.
Doctors, nurses, social workers, and other health professionals may be part of your treatment team.
Be sure to carefully follow instructions. If you don't know what you are supposed to do next, call your doctor. Or call the person responsible for your trial.
A medicine or treatment must go through three phases before it is approved for use by the U.S. Food and Drug Administration (FDA).
What happens when the clinical trial is finished?
After a clinical trial is completed and the results are studied, the FDA decides whether to approve continued development of the medicine. If the medicine that you received remains in development, you may be able to get more doses as an extension of the study.
If the results of the clinical trial show that the new medicine or combination of medicines works much better than standard treatment, the new medicine may become available to the general public.
Your treatment team may continue to check on you after your trial is over.
What are the risks?
You should be fully informed about the possible risks of the trial before you agree to participate.
- Although the purpose of trials is to find new and better treatments, the new treatment may not work as well as standard treatments.
- You may have unpleasant, serious, or even life-threatening side effects from the treatment.
- The treatment may not work for you.
- The trial may require more of your time than standard treatment. You may have to:
- Make more trips to the study site.
- Have more treatments.
- Receive your treatment in a hospital.
- Take more medicine more often or at very specific times.
- Keep a written diary of your experience.
How is your safety protected?
Every clinical trial in the United States must be approved and monitored by an institutional review board (IRB) to make sure that the risks are as low as possible and are worth any potential benefits.
The ethical and legal rules for medical practice also apply to clinical trials. Most clinical research is regulated by the U.S. government, with specific rules to protect the participants. Clinical trials follow a carefully controlled study plan (protocol) that explains what everyone will do in the study. During the clinical trial, researchers report the results of the trial at scientific meetings, to medical journals, and to government agencies. Your name will remain secret and will not be mentioned in these reports.