What Is It Like To Receive Treatment in a Study?
How Is the Research Carried Out? How Are Patients Protected?
Why Do Phase III Clinical Trials Compare Treatment Groups?
In a clinical trial, patients receive treatment and doctors carry out research on how the treatment affects the patients. While clinical trials have risks for the people who take part, each study also takes steps to protect patients.
When you take part in a clinical trial, you receive your treatment in a cancer center, hospital, clinic and/or doctor's office. Doctors, nurses, social workers and other health professionals may be part of your treatment team. They will follow your progress closely. You may have more tests and doctor visits than you would if you were not taking part in a study. You will follow a treatment plan your doctor prescribes, and you may also have other responsibilities such as keeping a log or filling out forms about your health. Some studies continue to check on patients even after their treatment is over.
In clinical trials, both research concerns and patient well-being are important. To help protect patients and produce sound results, research with people is carried out according to strict scientific and ethical principles. These include:
Each clinical trial has an action plan (protocol) that explains how it will work.
The study's investigator, usually a doctor, prepares an action plan for the study. Known as a protocol, this plan explains what will be done in the study and why. It outlines how many people will take part in the study, what medical tests they will receive and how often, and the treatment plan. The same protocol is used by each doctor that takes part.
For patient safety, each protocol must be approved by the organization that sponsors the study (such as the National Cancer Institute) and the Institutional Review Board (IRB) at each hospital or other study site. This board, which includes consumers, clergy and health professionals, reviews the protocol to try to be sure that the research will not expose patients to extreme or unethical risks.
Each study enrolls people who are alike in key ways.
Each study's protocol describes the characteristics that all patients in the study must have. Called eligibility criteria, these guidelines differ from study to study, depending on the research purpose. They may include age, gender, the type and stage of cancer, and whether cancer patients who have had prior cancer treatment or who have other health problems can take part.
Using eligibility criteria is an important principle of medical research that helps produce reliable results. During a study, they help protect patient safety, so that people who are likely to be harmed by study drugs or other treatments are not exposed to the risk. After results are in, they also help doctors know which patient groups will benefit if the new treatment being studied is proven to work. For instance, a new treatment may work for one type of cancer but not for another, or it may be more effective for men than women.
Cancer clinical trials include research at three different phases.
Each phase answers different questions about the new treatment.
Researchers assign patients by chance either to a group taking the new treatment (called the intervention group) or to a group taking standard treatment (called the control group). This method, called randomization, helps avoid bias: having the study's results affected by human choices or other factors not related to the treatments being tested.
In some studies, researchers do not tell the patient whether he or she is in the treatment or control group (called a single blind study). This approach is another way to avoid bias, because when people know what drug they are taking, it might change the way they react. For instance, patients who knew they were taking the new treatment might expect it to work better and report hopeful signs because they want to believe they are getting well. This could bias the study by making results look better than they really were.
Comparing similar groups of people taking different treatments for the same type of cancer is another way to make sure that study results are real and caused by the treatment rather than by chance or other factors. Comparing treatments with each other often shows clearly which one is more effective or has fewer side effects.
Another reason Phase III trials compare the new treatment with standard treatment is so that no one in a study is left without any treatment when standard treatment is available, which would be unethical. When no standard treatment exists for a cancer, some studies compare a new treatment with a placebo (a look-alike pill that contains no active drug). However, you will be told if this is a possibility before you decide whether to take part in a study.
Your Doctor Can Tell You More
If you have any questions about how clinical trials work, ask your doctor, nurse or other health professional. It may be helpful to print this information and discuss points you want to understand better.
Back to Top
< Previous Section | Next Section >
© Copyright 1996 - 2013 H. Lee Moffitt Cancer Center & Research Institute