What is a Clinical Trial?
Researchers are looking for treatment methods that are more effective against brain tumors and have fewer side effects. When laboratory research shows that a new method has promise, doctors use it to treat cancer patients in clinical trials. These trials are designed to answer scientific questions and to find out whether the new approach is both safe and effective. Patients who take part in clinical trials make an important contribution to medical science and may have the first chance to benefit from improved treatment methods. Many clinical trials of new treatments for brain tumors are under way. Doctors are studying new types and schedules of radiation therapy, new anticancer drugs, new drug combinations, combinations of chemotherapy and radiation, antiangiogenic therapy, gene therapy and immunotherapy. Patients interested in taking part in a clinical trial should discuss this option with their doctor. They may want to read Taking Part in Clinical Trials: What Cancer Patients Need To
A clinical trial is a study of a medical treatment in human subjects. The medical treatment can be a drug; a surgical device such as an artificial hip; a medical device such as an insulin pump; or a surgical technique. The purpose of a clinical trial is to answer questions about safety and effectiveness. We use them to determine whether we are using the best treatments or to help the Food and Drug Administration (FDA) determine whether or not to approve a treatment for general use.
Clinical trials are well-defined, well-monitored and controlled tests of new or experimental medical treatments. They are used to assess the effectiveness, side effects, and potential applications of medications, procedures, and other treatment approaches. A cancer immunology clinical trial, for example, might investigate the ability of cancer vaccines to help certain types of patients to avoid or overcome particular forms of cancer. Clinical trials are essential for medical progress, and patients can enroll in them voluntarily under the supervision of their physicians. Before a treatment is approved by the U.S. Food and Drug Administration (FDA), it must be studied in three phases of clinical trials.
A. A clinical trial is a scientific research study to evaluate new medications or other treatments like diet and exercise in human volunteers. Clinical trials must follow guidelines established by the government in each country. In the United States, the governing body is the Food & Drug Administration (FDA) and in Canada, it is the Therapeutic Health Directorate (TPD). Pharmaceutical or biotechnology companies, federal agencies such as the National Institutes of Health or the Department of Veteran’s Affairs, or private medical institutions and foundations, may sponsor clinical trials. Each trial requires volunteers, known as subjects, who fit specific guidelines or criteria. Clinical trials can be done in an inpatient or outpatient setting.
A clinical trial is a research study designed to answer questions about safety and effectiveness of a drug or treatment. These trials follow a rigorous scientific process with built-in safeguards for participants who volunteer and are selected for research. Most clinical research involves the testing of a new drug in an orderly series of steps, called phases. The process starts with small trials testing the safety of a treatment and then moves towards progressively larger trials. The larger trials compare the safety and effectiveness of the new therapy to the currently accepted standard of care. It is important to remember that in a clinical trial, researchers do not know if the new treatment will be more effective than the current standard of care treatment.
