NAPWA

This fact sheet provides you with information and some questions to ask if you are considering participating in a clinical trialA clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase IA clinical trial designed to establish whether an experimental drug is safe for humans to take. Phase I studies determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and look for early evidence of effectiveness; these studies may include either people with HIV, HIV-negative volunteers, or both tests a new drug or treatment in a small group; Phase IIA smaller clinical trial designed to establish whether a drug is effective. Phase II studies are conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. If there is evidence that the drug is effective, a Phase III study is undertaken, with a larger number of participaants, to confirm this. expands the study to a larger group of people; Phase IIIA large clinical trial designed to establish whether a drug is effective and safe enough for widespread use. Phase III studies include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. expands the study to an even larger group of people; and Phase IVPost-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use. takes place after the drug or treatment has been licensed and marketed. . read more »