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(Note: Find out more about clinical trials and read the ICCP Guide for Experimental Treatments for Spinal Cord Injury.)
Clinical trials are conducted on a wide variety of disease and conditions including topics related to spinal cord injury. There are three distinct phases in clinical trials that may lead to the FDA approval of a drug or therapy:
Phase I clinical trials are directly built upon basic and animal research and their primary goal is to test the safety of a therapy and to estimate possible usefulness in a small group (usually under 100) of human subjects.
Phase II clinical trials usually involve many subjects (usually a few hundred people) at several different research centers and are used to test safety and efficacy of a medication or surgical procedure on a broader scale, to test different dosing for medications or to perfect techniques for surgery, and to determine the best methodology for the larger Phase III clinical trial to come.
Phase III clinical trials often involve many centers and may include a few thousand subjects. These trials usually have several groups of subjects who receive different interventions (different doses of drugs or types of treatments) which are then compared for effectiveness against each other or against no intervention (placebo).
Human participation occurs in all three phases. If you are considering joining a clinical trial, the research staff will give you informed consent documents that include the details about the study. All clinical trials have guidelines about who can get into the program. Guidelines are based on such factors as age, type of disease, medical history, and current medical condition. Before you join a clinical trial, you must qualify for the study. Physicians involved in the care of your family member may be consulted as well.
The websites listed below can be used to find clinical trials:
Clinical trials vs. human experiments?
The difference between clinical trials and human experiments is that human experiments have in most cases not been medically proven and/or peer reviewed. This makes it difficult to determine the benefits or the patient outcomes. Clinical trials have a specific protocol to be followed and are looking for specific results.
Human experiments can pose a danger because they are not reviewed and monitored by an Institutional Review Board (IRB) for safety, ethics, and usefulness. In the United States, the Food and Drug Administration requires an IRB for all clinical trials.
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