In the discussion of cancer treatment, the term cancer clinical trials appears frequently. Also called research studies, cancer clinical trials test many types of treatment such as new drugs, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods. Cancer clinical trials are the first step in testing a new treatment in humans and their goal is to find better ways to treat cancer.
Cancer clinical trials include research at four different phases. Each phase answers different questions about the new treatment:
The questions being explored in Phase I cancer clinical trials are:
These cancer clinical trials involve a limited number of patients who may not be helped by other known treatments.
In Phase II of cancer clinical trials, the focus is on learning whether the new treatment has an anticancer effect on a specific cancer. Additional information regarding the side effects of the treatment is also obtained. A small number of people are included because of the risks and unknowns involved.
In Phase III of cancer clinical trials, a comparison of the results of people taking a new treatment is done with the results of people taking a standard treatment. Some of the questions being asked in a Phase III trial are:
Persons are assigned at random (a process similar to flipping a coin) to either the new treatment (treatment group) or the current standard treatment (control group). Randomization helps to avoid bias (having the study's results affected by human choices or other factors not related to the treatments being tested). Some cancer clinical trials compare a new treatment with a placebo (a look-alike pill/infusion that contains no active drug). However, a person is told if this is a possibility before deciding whether or not to take part in a study.
Comparing similar groups of people taking a different treatment for the same type of cancer is another way to make sure that the study results are real and caused by the treatment rather than by chance or other factors. These cancer clinical trials may include hundreds to thousands of people from different centers around the country.
In Phase IV of cancer clinical trials, also called post-marketing studies, cancer clinical trials are conducted after a treatment has been approved. The purpose of these cancer clinical trials is to provide an opportunity to learn more details about the treatment, such as:
These "post-marketing" trials may be conducted in a Phase I, II or III format.
In cancer clinical trials, patients receive treatment and doctors carry out research on how the treatment affects patients. A person's progress is closely monitored during the clinical trial. Once the treatment portion of the clinical trial has been completed, patients may continue to be followed in order to gather information regarding specific endpoints. These endpoints are defined prior to the study being started and may include time to disease progression and/or overall survival.
While cancer clinical trials have risks for the people who take part, each study also takes steps to protect patients. Cancer clinical trials are often the best or optimal treatment approach available.
Informed Consent is an ongoing process during cancer clinical trials in which all of the available information about the specific trial is discussed with the person participating in the trial. The doctor or nurse reviews the treatment plan, including potential risks and benefits of the treatment with the participant. This information is also written in a document (consent form) which is presented to the participant before treatment can begin.
After the potential study participant reads the document, an opportunity to ask questions about any parts of the form that are unclear is given. If the person agrees to participate in the study the consent form is signed. Signing the form indicates that the study participant read the form and the doctor or study nurse answered any questions about the information contained in the form, which may have been unclear.
Signing a consent form does not mean a person must stay in the study. In fact, people may leave cancer clinical trials at any time. If a person chooses to leave the study, a chance to discuss other treatment options and care with their doctor is given. A person may choose not to participate in the study, if so, their care will not be affected in any way.
The protocol is the action plan for cancer clinical trials. The plan states what will be done in the study and why. It outlines how many people will take part in the study, what types of patients may take part, what tests they will receive and how often, as well as the treatment plan. Each doctor that treats patients in the study uses the same protocol, and must follow the guidelines that are specified. The federal Food and Drug Administration (FDA) has general guidelines that must be followed by any physician or institution conducting cancer clinical trials. Before the FDA can approve a treatment, the study results are audited to ensure the trial was conducted safely and according to these guidelines.
For patient safety, each protocol must also be approved by the organization that sponsors the study. The Scientific Review Committee, a group of individuals from the institution, including physicians, scientists, nurses, administrators, review the protocol for scientific merit and feasibility of the protocol. The Institutional Review Board (IRB), of the hospital, must also approve it. This board includes consumers, clergy, and health professionals. They review the protocol to try to be sure that the research will not expose patients to extreme or unethical risks.
Eligibility criteria are guidelines from the protocol, which describe the characteristics that all participants in the study must have. These criteria differ from study to study, depending on the purpose of the research. Examples are; age, gender, the type and stage of cancer; and whether cancer patients who have had prior cancer treatment or have other health problems can participate.
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