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Clinical trials are research studies in which doctors, patients and scientists are trying to find ways to improve cancer care. Each study is aimed to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer.
Why are there clinical trials?
A clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective.
What are the different types of clinical trials?
• Treatment trials
These trials are designed to test new treatments such as new cancer drugs, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods (e.g. gene therapy). See Taking Part in Clinical Trials: What Cancer Patients Need to Know.
• Prevention trials
These trials are designed to test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer. The trials look for the best way to prevent cancer in people who have never had cancer or to prevent cancer from coming back or a new cancer occurring in people who have already had cancer. See Understanding Prevention Trials for additional information.
• Screening trials
The trials test the best way to detect cancer, especially in its early stages. See Understanding Screening Trials for additional information.
• Quality of Life trials
Also called Supportive and Palliative Care trials explore ways to improve comfort and quality of life for cancer patients. See Supportive and Palliative Care Research Clinical Trials for additional information.
What are the phases of clinical trials?
Most clinical research that involves testing of new drugs or medical devices is done in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a scientific and reliable way and to protect patients from unnecessary risks. Clinical trials are usually divided into three phases:
• Phase I trial: This first phase evaluates how a new drug should be given (by mouth or injection), 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 trial: The second phase continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies are usually focused on a particular type of cancer.
• Phase III trial: This phase tests a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. The goal of the study is to determine if the drug, or the procedure, or the new device is really improving the outcomes of the treatment. Participants are usually assigned randomly to the standard or the new group in the study (this is called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide and internationally.
Information from: http://www.cancer.gov/about-cancer/treatment/clinical-trials