If you are an MDS patient, you may wish to discuss a trial with your primary treating physician to see if you qualify as a candidate. Clinical trials study new interventions (drugs or procedures) to evaluate their safety and effective-ness in humans. Trials follow a careful set of steps, allowing for the systematic gathering of information to answer questions and confirm hypotheses that were formed earlier, in either laboratory experiments or preliminary trials. A clinical trial falls into one of four phases: Phase IThis is the first time a drug is used in humans. The trial is designed to determine dosage, route of administration (oral, intravenous, or by injection), and schedule of administration (how many times a day or week). In this phase, researchers also begin to determine the drug's safety. The Phase I trial is normally conducted in healthy adults and enrolls only a small number of people. Phase IIPatients with the disease receive the drug at dose levels determined in the earlier phase. The Phase II trial begins to determine the effectiveness of the drug and provides more information about its safety. Phase IIIThe drug is tested alone or against an approved standard drug. The typical Phase III trial enrolls a large number of patients. If it is a comparison trial, patients may be randomly assigned to receive either the new drug or the standard intervention. Phase IVIn Phase IV the drug, already approved by the FDA and available to the public, undergoes continued evaluation. The Phase IV designation is rare.
Some trials, screening trials and studies evaluating supportive care or prevention are not conducted in phases. In this type of trial, a group following a certain strategy to combat disease, such as a detection method or a behavioral change, is compared to a control group.
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