Phases in the drug development process in which the effects of a drug are tested in humans.
Human studies designed to distinguish a drug's effect from other influences--for example, a spontaneous change in disease progression or in the effect of a placebo (an inactive substance that looks like the test drug). Such studies conducted in this country must be under an approved IND (see "Investigational New Drug Application"), under the guidance of an institutional review board, and in accord with FDA rules on human studies and informed consent of participants.
Studies of humans under controlled conditions.
Clinical development is subdivided into three phases. Phase I studies verify the safety and tolerability of the drug candidate in healthy volunteers. Phase II studies control the therapeutic efficacy of the drug candidate besides safety and tolerability issues in a small cohort of patients. Phase III trials survey the clinical efficacy and the clinical benefit and safety of the new candidate in comparison to accepted therapies and placebo.
A process of strictly controlled evaluations involving patients. Some of these studies are required by the FDA prior to general release of a device or compound for use in humans.
Tests of the effectiveness and safety of a treatment on people who have the illness the treatment is intended to help.
Scientific studies that test the safety or effectiveness of products. They are a part of a NDA submission, and are used for currently marketed products to make claims. For example, a clinical study may test the performance of a nasal decongestant versus an oral decongestant to see if one product is faster-acting than the other. Types of Clinical Studies: Phase I: The main aim of this phase is to determine drug safety. Phase II: These trials are aimed at early testing to see if the drug or product works and what would be the best dose to be used in Phase III trials. Phase III: These studies, which can take several years and involve thousands of patients, are aimed at an in-depth determination of the drug or product's effectiveness and its side-effect profiles. Phase IV/postmarketing surveillance: After a drug or product has been marketed, a company may conduct further studies of its performance, or long-term safety. This is helpful to make new claims that may not be included in previous approvals or in the monograph.
(Also clinical trials, clinical outcomes studies, controlled trials, case series, comparative trials, or practice audit evidence.) Tests of a treatment's effects in humans. Treatments undergo clinical studies only after they have shown promise in laboratory studies of animals. Clinical studies help researchers find out whether a promising treatment is safe and effective for people. They also tell scientists which treatments are more effective than others.
Studies of humans suffering from symptoms induced by chemical exposure.
Human studies to test a device, drug, or treatment to verify or test if it is safe and effective. The Food and Drug Administration (FDA) requires that new drugs, medical devices, or treatments undergo clinical trials and studies before they can be approved for widespread use.
