Clinical Trial Frequently Asked Questions

What is a clinical trial?

A clinical trial is a research study of a new treatment that has already been successfully tested in laboratory animals and is ready to be tried on humans. It is designed to answer specific questions about a new drug or treatment.

What are the phases of clinical trials?

Phase I: In Phase I clinical trials, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II: In Phase II clinical trials, the study drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III: In Phase III studies, the study drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.

Phase IV: Phase IV studies are often done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use.

What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate. These facts include:

• Why the research is being done
• What the researchers want to accomplish
• What will be done during the trial and for how long
• What risks are involved in the trial
• What benefits can be expected from the trial
• What other treatments are available
• The fact that you have the right to leave the trial at any time

If you are considering joining a clinical trial, the research staff will give you informed consent documents that include the details about the study. If English is not your native language, you can ask for the consent documents in languages other than English. Since joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study and the consent forms before you make a decision.

It is also a good idea to take the consent documents home and discuss them with family members or friends. Talking about your options can help you to feel comfortable with your decision. If you decide to join a clinical trial, be sure to ask for a copy of the informed consent documents so you can review them at any time.

Informed consent is more than signing a form. It is a process that continues through the study. You should feel free to ask the research team questions before, during and after the study. Informed consent continues as long as you are in the study.

What are the benefits and risks associated with clinical trials?

There are both benefits and risks associated with clinical trials. By participating in a clinical trial, you can:

• Take an active role in your own health care
• Gain access to new treatments that are not available to the public
• Obtain expert medical care at leading health care facilities during the trial
• Help others by contributing to medical research

Clinical trials have risks:

• There may be side effects or adverse reactions to medications or treatments
• The treatment may not be effective for you

What should I know before I participate in a clinical trial?

You should know as much as possible about the research study. It is very important for you to feel comfortable asking questions and the staff should answer them in a way you can understand.

What questions should I ask?

Some questions you might ask about the research include:

• Why is the research being done
• What is the purpose of the study
• Who is sponsoring the study
• Who has reviewed and approved the study

Some questions about your participation in the study include:

• Where is the study site
• What kinds of therapies, procedures, and/or tests will I have during the trial
• How long will the study last
• How often will I have to go to the study site
• Will I be able to take my regular medications during the trial
• What medications, procedures, or treatments must I avoid while in the study
• Can anyone find out that I am participating in a study
• Can I talk to other people in the study
• Will I be able to find out the results of the trial

Other questions include:

• What other treatment options do I have
• What are the costs associated with participating
• Is my insurance likely to cover those expenses

Can I leave a clinical trial after it has begun?

Yes. You can leave a clinical trial at any time. If you plan to stop participating, let the research team know why you are leaving the study. You will likely be asked to participate in attending some end of treatment sessions.