Clinical trials are research studies that test new treatments to prevent or treat disease, symptoms of diseases or the side effects of other treatments.
Clinical trials may test new ways of using an existing drug. For example, there may be a question of whether a higher dosage may help more than the currently prescribed dose or if two drugs work better in combination. A clinical trial may also be for a new drug to treat a disease.
The Food and Drug Administration requires that a company perform clinical trials to demonstrate the new treatment is safe and effective.
- A member of the study staff will ask you questions or review your medical information to see if the study is an appropriate match for you.
- If you are eligible to participate you will be given a consent form that explains the trial and what you will have to do.
- You will undergo a physical exam and medical tests as necessary.
- You will be medically monitored on a regular schedule. If at any time you do not respond well or get worse, the physician will stop the study and you will receive treatment.
You have the right to:
- Informed consent: This means all the information about the study will be explained to you and will have the opportunity to ask questions before you agree to participate in the study.
- Leave a clinical trial at any time for any reason.
- Some of the medical information that is collected during the trial, such as some medical tests.
- Know what other healthcare options are available for you if you choose not to participate in a study.
All medical and personal information collected during a clinical trial is confidential. We will not share your information with anyone without your consent.