- Clinical Trials: What You Need to Know
- Why do we need clinical trials?
- What happens before a clinical trial starts?
- Some facts about clinical trials to keep in mind
- What are the phases of clinical trials?
- Phase 0 clinical trials: Exploring if and how a new drug may work
- Phase I clinical trials: Is the treatment safe?
- Phase II clinical trials: Does the treatment work?
- Phase III clinical trials: Is it better than what’s already available?
- Submission for FDA approval: New drug application (NDA)
- Phase IV clinical trials: What else do we need to know?
- Who sponsors and runs clinical trials?
- Should I think about taking part in a clinical trial?
- Answers to some common questions about clinical trials
- Other questions you should ask your research team
- How are study participants protected?
- What’s out there? Finding clinical trials
- How do I figure out which study is for me?
- What about cost? Will my insurance cover it?
- Private insurers and the new health care law
- What would it be like to be in a clinical trial?
- What if I’m not eligible for a clinical trial?
- Summing it all up
- To learn more
What would it be like to be in a clinical trial?
Having an idea of what you can expect from taking part in a study can help relieve some of your concerns. The first thing you’ll need to do is give your informed consent to take part in the clinical trial.
Informed consent or informed permission
The people running the clinical trial must get your written, informed consent before you take part in any way (often even before you have any needed tests to see if you are eligible for the study). In the informed consent process, the researchers (doctors or nurses) will explain the details of the study to you and answer your questions and concerns. If you are looking at a study for your child, this process is very much the same but may be called informed permission.
You will then be given a written consent form to sign. Parents must sign the form for their child, and in most cases older children must also agree before they take part. (This is called assent.) In general, these children’s rights are very much like those of adults, including the right to leave the study anytime they want. Consent forms are not all the same, but they should include the following:
- The reason for the study (what the researchers hope to find out)
- Who is eligible to take part in the study
- What’s known about the new type of treatment
- The possible risks and benefits of the new treatment (based on what’s known so far)
- Other treatments that may be an option for you
- The design of the study (whether it’s randomized, double blinded, etc.)
- How many and what types of tests and doctor’s visits are involved
- Who must pay for the costs of the clinical trial (tests, doctor’s visits, etc.) and for the costs if you need extra care as a result of the clinical trial
- A statement about how your identity will be protected
- A statement about the voluntary nature of the study and your right to leave the study at any time without fear of affecting the care that you would normally get outside the study
- Contact information in case you have questions at any time before and during the study
Before you sign the consent form, ask questions. Be sure someone from the research team goes over the form with you. Consent forms are not all easy to understand, and there may be words or ideas that seem confusing. You may want to bring someone along with you to the meeting to help make sure all your concerns are addressed.
Be sure you understand what’s involved and what’s expected of you. Review what you understand about the study with your doctor or nurse to make sure you’ve got it right.
Finally, don’t feel rushed into making a decision. Take the consent form home with you if you need to. Ask trusted family members and friends what they think. Some people may want to get a second opinion about the study from another doctor, too.
Taking part in the study
Once you’ve signed the consent form, you’ll be ready to take part in the study. You’ll probably need to have blood tests and/or imaging tests done before you start treatment (if you haven’t had them recently). A full medical history is taken and a physical exam is also usually done. The results are needed before you start the study to be sure that you meet the eligibility criteria and to help ensure your safety.
As mentioned earlier, some studies may require you to stay in a hospital for a day or 2 to get treatment. In other studies the participants are treated much the same way as other patients who aren’t in a clinical trial.
You may have tests done more often to find out how well the treatment is going and to look at how you’re doing. You’ll likely get more attention as a study participant than you would otherwise. The doctors and nurses may examine you more often and will want to know if you’re having any side effects (called adverse events) while being treated.
Because the possible complications may not fully be known, it’s very important to let the research team know about anything out of the ordinary. They can then decide if symptoms you’re having are related to the study, and if they need to be treated or your treatment needs to be changed.
You may quit taking part in the study at any time and for any number of reasons:
- You complete treatment on the study
- The treatment doesn’t appear to be working for you
- You have serious side effects while in the study
- The study itself is stopped early because the treatment either has proven to work, has proven to not work as well as the standard treatment, or it’s been found to be too harmful
- You decide to leave the study
Once you’re out of the study, the researchers may still watch you for a time so they can continue to get an idea of how you’re doing.
Some studies let you stay on the new treatment even after the study ends. This is known as open label, because you and your doctor know which treatment you are getting. This option varies among clinical trials, so be sure to ask about it before you begin.
What if I want to leave the study early?
You will be told many times before you enter the study that taking part in the study is always voluntary. This is an important point. You (or your child) have the right to leave the study at any time, for any reason. Your doctor will still take care of you to the best of his or her ability.
No matter when or why you leave the study, the researchers may ask to follow up with you from time to time to see how you are doing. This can give them important information and can also help ensure your safety, even though you’re no longer taking part in the study.
Last Medical Review: 09/25/2014
Last Revised: 10/31/2014