information provided by Stuart Schlossman
December 28, 2011
A clinical trial is a research study that is performed in humans to determine if a new drug or therapy is both safe and effective for treating a disease or condition. All clinical trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.
Clinical trials are carried out in steps called phases. Patients may be eligible for studies in different phases, depending on their general condition, the type and stage of their disease, and what therapy, if any, they have already had. Trial participants are seen regularly by research staff to monitor their health and to determine the safety and effectiveness of their treatment.
On average, it takes twelve years for a drug to travel through the clinical testing phases to reach the patient population. Approximately one in five drugs that enter clinical testing are ultimately approved for patient use. The following is a description of what makes up each stage in the U.S. clinical trial process:
Before a drug can be tested in humans, pre-clinical testing is required. Laboratory studies are conducted to demonstrate safety in humans and the drugs’ ability to fight against a targeted disease. Once the drug has been determined to have strong potential, it begins to be prepared for human delivery. Pre-clinical testing takes approximately three to four years.
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