Questions to ask before participating in a clinical trial
Before you agree to participate in a clinical trial, make sure you know the answers to these questions:
- Who is in charge of this study?
- Do the people running the study have a vested interest (conflict of interest) in the outcome?
- What is this study trying to find out?
- What will be expected of you?
- Is it possible that you might receive a placebo?
- What benefits or risks can you expect if you take part in this study?
- How long will the study last?
- What happens if your condition gets worse during the study?
- Can you continue seeing your own doctor during the study?
- Will you need to pay for any part of the study, including doctor visits and routine tests?
- Who pays if you're unexpectedly injured during the trial?
- How will your participation in the study affect your daily life?
- What happens at the end of the study?
- Will you be told the results of the study? When?
- Who will know that you're participating in the study?
How do clinical trials protect participants' safety?
The same ethical and legal rules that govern medical practice apply to clinical trials. In addition, most clinical research is federally regulated with safeguards to protect the participants. Clinical trials must follow a scientific action plan called a protocol. The protocol explains what will be done in the study and why. It outlines:
- Who may participate
- How many people will take part
- What the treatment plan entails
- The type and frequency of tests
- How the results will be measured
- The reasons that a study may be stopped
- The situations in which researchers may stop giving the treatment to participants
- The likely or known side effects of the treatment
- The possible benefits of the treatment
The organization that sponsors the study, such as the medical center where the work will be done, must approve the protocol. In addition, an institutional review board must review the protocol to be sure that participants are treated humanely and ethically, and to evaluate whether the likely benefit of the treatment is worth its risk. The review board also checks to see if any of the researchers have substantial conflicts of interest.
A clinical trial may also have a data safety monitoring board overseeing it. As the name suggests, this board monitors the safety of the study participants. The data safety monitoring board can stop a study at any time if it seems that the treatment isn't working or it's causing too many side effects. A trial can also be halted by the board if the treatment is proving to be better than the standard treatment and therefore should be made available to people outside of the clinical trial.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. During this process, you learn about the purpose of the trial, as well as key details such as:
- What will happen during the clinical trial, including planned tests
- Known risks and benefits of the experimental treatment
- How long you'll be expected to participate in the clinical trial
- Other treatments that might be helpful to you instead of the treatment being tested
- Whom to contact with questions
You must sign an informed consent form to take part in a clinical trial, but it isn't a contract. If you later decide to leave the study, you can do so at any time.
If your child will be enrolled in a clinical trial, you will go through the informed consent process together. As the parent or guardian, you will have to give permission for your child to participate. Depending on your child's age, researchers may also ask your child directly if he or she agrees to be in the study.
How to decide if a clinical trial is for you
By participating in a clinical trial, you can gain access to new research treatments and help others by contributing to medical research. However, clinical trials aren't without risks. For one thing, the experimental treatment may not work for you. Or you may experience unpleasant, serious or even life-threatening side effects. If you're considering a clinical trial, it's essential to get all the facts and to talk with your doctor about the potential risks and benefits.
Jul. 02, 2011
See more In-depth
- Frequently asked questions. ClinicalTrials.gov. National Institutes of Health. http://www.clinicaltrials.gov/ct2/info/understand. Accessed April 5, 2011.
- Clinical trials: Questions and answers. National Cancer Institute. http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials. Accessed April 5, 2011.
- Basic questions and answers about clinical trials. U.S. Food and Drug Administration. http://www.fda.gov/oashi/clinicaltrials/clintrialdoc.html. Accessed April 5, 2011.
- How to enroll in a clinical trial. National Cancer Institute. http://bethesdatrials.cancer.gov/general-public/index.asp. Accessed April 5, 2011.
- A guide to understanding informed consent. National Cancer Institute. http://www.cancer.gov/clinicaltrials/conducting/informed-consent-guide. Accessed April 5, 2011.
- Clinical trials. Mayo Clinic. http://clinicaltrials.mayo.edu/. Accessed April 5, 2011.