Why do people participate in clinical studies?
People participate in clinical trials for a variety of reasons. Some of the main reasons people want to participate in a study is to find a cure for themselves, extend their life or find a way to feel better. Many cancer patients participate in clinical trials because they offer the patient a new alternative to standard treatment before it is available to the general public. They may also wish to participate because there is currently no other effective therapy for their disease or because they wish to help in researching the disease so that future generations may benefit from the results.
Are there risks or side effects in clinical studies?
With any new treatment there may be risks as well as possible benefits. There may also be some risks that are not yet known. There are no guarantees that the drug or device being studied will be effective when used in treating patients. The principal investigator or study coordinator of a clinical trial will explain the potential degree of risk and the potential benefits to the patient before s/he consents to become a participant in a clinical study. Only after learning about all associated risks and possible benefits should the patient make the decision about whether s/he will participate in the study or not.
Are study participants required to pay for clinical studies?
Each study is different in what is and is not covered during the conduction of the clinical study. For example, some studies pay for all medications, doctor visits, tests, and treatments. Other studies will only provide the study drug at no cost to the patient and will submit the cost of other procedures and tests to the patient or their insurance company. Patients should make sure they are aware of the costs involved in their treatment prior to participating in a clinical trial.
What is a placebo?
A placebo is an inactive, harmless agent used for testing against the active drug. The results of the active compound are compared with the placebo to better understand the actions of the active drug. One group of patients will receive the experimental drug, while a second control group receives a standard treatment or placebo. Often the participant, physician and the study coordinator are unaware of or blind to which group is getting the actual drug and which is receiving the placebo. The blind trial method prevents bias on the part of the patient and the doctor.
Can patients leave a clinical trial at any time?
Just as patients can refuse to participate in treatment, they may choose to stop participation in a clinical trial at any time. A physician can also withdraw the patient from the study if new potential risks are found that could be life-threatening or if the physician feels that the patient is no longer benefiting from the treatment.
What is informed consent?
Informed consent is required for participation in all clinical studies involving human subjects. Individuals are given information about what is involved in the study, including possible benefits and risks. Questions are encouraged by the physician or study coordinator. After this information is presented, individuals can make a decision whether to consent to participate or not. The patient’s consent to participate is documented in his/her medical history.
What questions should I ask my physician about clinical trials?
It is important that you are comfortable that you have all of the information before you decide to participate in a clinical trial. Below are some questions that you may want to ask your physician. You may want to bring along a friend or relative when you talk to the physician, so that both of you can ask questions. Also, it may help to write down your questions and the answers you receive so that you can better evaluate your choices.
Questions to ask your physician:
- What is the purpose of the study?
- In what phase is this study?
- Why do researchers believe the new treatment being trialed may be effective?
- Has it been trialed before?
- What were the results of the previous studies?
- Who is sponsoring the study?
- Who has reviewed and approved it?
- How are the study results and safety of the participants being checked?
- How long will the study last?
- Will I ever know if I’m taking the new treatment that’s being study?
- What are the short-term and long-term benefits for me?
- What are the possible side effects?
- What other options do people with my type of cancer have?
- What kind of therapies, tests, or procedures will I have during the trial?
- How often and for how long will I receive the treatment, and how long will I need to remain in the study?
- Where will my treatment take place?
- Will I have to be in the hospital? If so, how often and for how long?
- Will I be able to see my own physician?
- Will I be able to take my regular medications?
- How will the study affect my life?
- Can I talk to other people who are in the study?
- Will I have to pay for any part of the trial such as tests or medication? If so, what is the cost?
- What is my health insurance likely to cover?
- Who can answer questions from my insurance company or managed care plan