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Our research protocols are in conjunction with RTOG and The Division of Hematology & Oncology at UTMB Our disease site research protocols are:
PHASES There are three Phases that most Studies will go through prior to becoming a standard Treatment (Studies must show acceptable results prior to moving to the next phase). Phase I: Phase I includes the initial introduction of an investigational new drug into humans. These studies are closely monitored and may be conducted in patients, but are usually conducted in healthy volunteer subjects. These studies are designed to determine the metabolic and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. Phase I studies also evaluate drug metabolism, structure-activity relationships, and the mechanism of action in humans. These studies also determine which investigational drugs are used as research tools to explore biological phenomena or disease processes. The total number of subjects included in Phase 1 studies varies with the drug, but is generally in the range of twenty to eighty. In Phase I studies, CDER can impose a clinical hold (i.e., prohibit the study from proceeding or stop a trial that has started) for reasons of safety, or because of a sponsor's failure to accurately disclose the risk of study to investigators. Although CDER routinely provides advice in such cases, investigators may choose to ignore any advice regarding the design of Phase 1 studies in areas other than patient safety. Phase II: A little larger group of patients are enrolled, the study's main goal is to evaluate the risks, safety and effectiveness of new treatments. Phase III: A large number of patients are enrolled, to prove the effectiveness of treatment, or to compare two different types of treatment.
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