Paralysis Resource Guide - (Page 164) RESEARCH CLINICAL TRIALS Drugs and treatments are developed—or as the research community says it, “translated” from laboratory experiments. Clinical research is usually conducted via a series of trials that begin with a few people and become progressively larger as safety and efficacy are better understood. Because full-scale clinical trials are expensive and time consuming, only the most promising of many treatments emerging from research labs are selected in the translation process. A National Institute of Neurological Disorders and Stroke panel noted that future trials on treating paralysis should be based on minimum risk with significant benefit in a relevant animal model that has been independently replicated by other labs. Questions remain as to what the minimal clinical improvement would be to warrant various levels of risk and expectation. Once laboratory and animal studies show promise, a Phase I clinical trial is initiated. Phase I is primarily used to test the safety of a therapy for a particular disease or condition. A Phase II clinical trial usually involves more subjects at several different centers and is used to test safety and efficacy on a broader scale, such as to test different dosing for medications or to perfect techniques for surgery. A Phase III clinical trial involves many centers and sometimes hundreds of subjects. The trial usually involves two patient groups comparing different treatments, or, if there is only one treatment to test, patients who do not receive the test therapy get a placebo (dummy drug) instead. Many Phase III trials are double-blinded and randomized. Doubleblind means that neither the subjects nor the doctors treating them know which treatment a subject receives. Randomization refers to the placing of subjects into one of the treatment groups in a way that can’t be predicted by the patients or investigators. Phase IV is carried out after approval in order to detect possible rare undesirable side effects which had escaped attention in the previous phases. 164
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