What is a clinical research trial?
Clinical trials are research studies that help find:
- Potential new medications
- New versions of medications already being used
- New uses for medications already being used
The Food and Drug Administration requires that a company perform clinical trials to demonstrate the treatment is safe and effective.
What can I expect if I enroll in a clinical trial?
- A member of the study staff will ask you questions or review your medical information to see if the study may be an appropriate match for you.
- If you are eligible to participate you will be given an informed consent form that explains the trial and what will happen and when. You will have all the time you need to review this information and we encourage you to share this information and discuss your participation with your family or others with whom you are close, as well as your healthcare providers.
- Before participating in a clinical trial, the study doctor or staff will answer any questions you may have about the study. If you choose to participate, you will be asked to sign the informed consent form for the study.
- Once you have signed the informed consent form, the study team will carry out some assessments to check that you and the study are a good fit.
- If this study is the right match for you, there will be study visits on a regular schedule. This schedule varies based on each research study.
- If at any time you do not respond well or get worse, the study doctor will stop the study and you will receive treatment.
What are my rights if I choose to participate?
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. This also means that study staff will share any new information we receive about the study with you as soon as it is available. When a person participates in a research study, we encourage them to share any questions or concerns throughout 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.
Is my participation confidential?
All medical and personal information collected during a clinical trial is confidential. We will not share your information with anyone without your consent.