July 2006, Volume 36 Number 7 , p 22 - 23
DIMSDALE, ALLISON WALP RN, CCRN
EXCITING HEALTH CARE discoveries can debunk current guidelines, shatter closely held beliefs, and open our eyes to new treatments. These advances are achieved with clinical trials—and you can play a key role. In this article, I'll tell you how clinical trials are conducted, how to protect your patient's legal rights, and how to provide nursing care to a patient participating in a clinical trial.
A clinical trial typically has four phases, although the sponsor and the Food and Drug Administration will stop a trial that doesn't show beneficence or is dangerous.
* Phase I is the first test of a drug in humans. The objectives of this phase are to determine drug safety and a safe dosage range, assess absorption and distribution in the body, and identify possible toxicity. A limited number of healthy volunteers or patients—usually 20 to 80—participate in this initial phase, which may ...