Clinical Trials offer health care provided by leading physicians in a variety of fields of research. There are several types of clinical trials that are conducted at Eisenhower Health, including:
- Treatment trials which test new treatments, like a new drug, new approaches to surgery or therapy, new combinations of treatments, or new methods such as gene therapy.
- Prevention trials which test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain diseases. These trials look for the best way to prevent diseases in people who are at risk.
- Screening trials which test the best way to find diseases, especially in its early stages.
- Quality of Life trials (also called Supportive Care trials) which explore ways to improve comfort and quality of life for patients.
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of three phases:
- Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
- Phase II trials: A phase II trial continues to test the safety of the drug and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.
- Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization 10). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.
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Only you can make the decision about whether or not to participate in a clinical trial. Before you make your decision, you should learn as much as possible about your disease and the trials that are available to you. Then, talk about this information and how you feel about it with your doctor and/or nurse, family members and friends to help you determine what is right for you.
What are the potential risks and benefits of clinical trials?
Potential benefits include:
- Health care provided by leading physicians in the field of research
- Access to new drugs and interventions before they are widely available
- Close monitoring of your health care and any side effects
- A more active role in your own health care
- If the approach being studied is found to be helpful, you may be among the first to benefit
- An opportunity to make a valuable contribution to research
The potential risks include:
- New drugs and procedures may have side effects or risks unknown to the doctors
- New drugs and procedures may be ineffective, or less effective, than current approaches
- Even if a new approach has benefits, it may not work for you
How are participants protected?
The government has a system designed to protect human research subjects. Before a government-funded clinical trial can begin, the trial plan (also called a protocol) must be approved. During the trial, review committees make sure that the plan is being followed and participants are being protected.
Regulations require the researchers performing studies to thoroughly inform patients about a study's treatments and tests and their possible benefits and risks before a patient decides whether or not to participate in any study. This process is called informed consent.
What is informed consent?
Informed consent is a process in which you learn the key facts about a clinical trial before you decide whether or not to participate. In addition to talking about these facts with the research doctor or nurse, they will be included in a written consent form that you can take home to read and discuss. The consent form will include details about:
- the study approach
- the intervention given in the trial
- the possible risks and benefits
- the tests you may have
Don't hesitate to ask questions until you have all the information you need. While informed consent begins before you agree to participate in a trial, you should feel free to ask the health care team any questions you have at any point. Informed consent continues as long as you are in the study. You can change your mind and leave the study whenever you want, before the study starts or at any time during the study or follow-up period.
Could I receive a placebo?
In most treatment trials, placebos ("dummy" pills that contain no active ingredient) are very rarely used. Many treatment trials are designed to compare a new treatment with a standard treatment, which is the best treatment currently known based on results of past research. In these studies, patients are randomly assigned to one group or another. When no standard treatment exists, a study may compare a new treatment with a placebo; however, you will be told about this possibility during informed consent, before you decide whether or not to take part in the study.
What happens during a trial?
If you decide to participate in a clinical trial, you will work with a research team. Team members may include doctors, nurses, social workers, dieticians, and other health care professionals. They will provide your care, monitor your health carefully, and give you specific instructions about the study.
During the Trial
Participating in a trial may mean that you might have more tests and doctor visits than you would if you weren't in the study. Team members also may continue to stay in contact with you after the trial ends. To make the trial results as reliable as possible, it is important for participants to follow the research team's instructions. That means having all doctor visits and tests, taking medicines on time, and completing logs or answering questionnaires.