In cancer research, a clinical trial is a study designed to answer scientific questions. Some clinical trials test new treatments, investigate new ways of preventing cancer and monitor the quality of life and/or psychological impact of cancer while others detect cancer in its earliest stages.
Clinical research is the bridge between basic laboratory research and what is made available to the patient. Once drug development has been completed from initial laboratory studies, clinical trials progress through phases of testing. The trials are identified as Phase I, Phase II, Phase III.. Each phase of a clinical trial protocol attempts to answer questions that will enhance and improve cancer treatment and therapies.
Phase I
Phase I studies test a particular treatment in humans after it has been studies in the laboratory. The purpose of Phase I studies is to determine the maximum tolerated dose or amount of the treatment and answer questions about the best way to give the new treatment. Phase I studies are carefully controlled by the NCI’s Regulatory Affairs Branch with the Cancer Therapy Evaluation Program (CTEP). Phase I studies are carried out by knowledgeable investigators who meet certain criteria set by CTEP.
Phase II
Once Phase I studies have been completed and a dosage level is known, Phase II studies can start. Phase II studies test the treatment in humans in various types of cancer to determine the effectiveness of the agent against a given tumor type. Additional information on side effects may also be gained.
Phase III
If treatment is found to be effective, Phase III studies compare it to the standard treatment. This is done by having two or more "arms" of treatment in which patients are randomly selected to participate. The arm in which the patient participates is decided by chance (by computer) not choice. This randomization assists in making the groups as equal as possible so that sound conclusions can be drawn from study results. Patients are randomized by a number of factors that may affect the outcome of the study (age, performance status, tumor grade, stage of disease, etc…). In all treatment arms, patients receive the best care available.
Informed Consent
Every patient participating in a medical research study, by law in the United States, must sign an informed patient consent form that explains the research study, the foreseeable risks, benefits other appropriate treatments, and where to find further information. It also explains a patient’s rights as a participant in the trial. If at anytime a participant is not comfortable with the trial, they have the right to withdraw. Also confidentiality of patient’s records is assured.
