clinical trial

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trial

 [tri´al, trīl]
a test or experiment.
clinical trial an experiment performed on human beings in order to evaluate the comparative efficacy of two or more therapies. See also single blind, double blind, and triple blind.

clinical trial

a controlled experiment involving a defined set of human subjects, having a clinical event as an outcome measure, and intended to yield scientifically valid information about the efficacy or safety of a drug, vaccine, diagnostic test, surgical procedure, or other form of medical intervention.

Four phases of clinical trial are distinguished. Phase I trials usually involve fewer than 100 healthy volunteers who are exposed to a new drug or procedure. Such studies seek to establish optimal dosage and route of administration and to detect adverse reactions. Phase II trials generally involve 200-500 volunteers randomly assigned to control and study groups. These are pilot efficacy studies, with emphasis on immunogenicity in the case of vaccines, and on relative efficacy and safety in the case of drugs, procedures, and devices. Phase III trials, often multicenter, involve thousands of volunteers, randomly assigned to control and study groups. The aim is to generate statistically relevant data. Phase IV trials are conducted after a national drug registration authority (in the U.S., the Food and Drug Administration) has approved an agent for distribution or sale. They may explore specific pharmacologic effects, adverse reactions, or long-term effects.

clinical trial

n.
A research study using consenting human subjects that tests the effectiveness and safety of a treatment, a diagnostic tool, or a prophylactic intervention.

clinical trial

A research study involving human subjects designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device), or new ways of using a known drug, treatment or device.

clinical trial

Clinical medical trial, clinical research trial Research A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or behavioral interventions. See Drug discovery, IND, Phase I, II, and III studies.

clin·i·cal trial

(klini-kăl trīăl)
A controlled experiment involving a defined set of human subjects, having a clinical event as an outcome measure, and intended to yield scientifically valid information about the efficacy or safety of a drug, vaccine, diagnostic test, surgical procedure, or other form of medical intervention.

clinical trial

a scientifically controlled study under specific conditions, to test, for example, the effectiveness of a drug/ treatment.

Clinical trial

All new drugs undergo clinical trials before approval. Clinical trials are carefully conducted tests in which effectiveness and side effects are studied, with the placebo effect eliminated.

trial, randomized controlled (RCT) 

An experimental design used for testing the effectiveness of a new medication or a new therapeutic procedure. Individuals are assigned randomly to a treatment group (experimental therapy) and a control group (placebo or standard therapy) and the outcomes are compared. The trial is strengthened by 'blinding' or masking (single-blind, double-blind or triple-blind study) and cross-over design. RCT is the most accepted scientific method of determining the benefit of a drug or a therapeutic procedure. It represents the best evidence available, which is integrated into the final decision about the management of a condition by healthcare practitioners in what is called evidence-based healthcare. Syn. randomized clinical trial. See sampling; significance; study.

clinical trial,

n a trial based upon the scientific method in which a control group and a test group are compared over time in order to study a single, differing factor.
References in periodicals archive ?
Although these Phase IV trials are largely voluntary, drug companies have realized that many post-marketing studies are critical to the success of the brand's reimbursement strategy.
Use detailed case studies to understand the influence of phase IV trials upon lifecycle management, indication expansion and reimbursement
Evaluate the operational objectives and trial management/outsourcing trends for phase IV trials across key industry sectors
Key Topics Covered: The Emerging Role of Postmarketing Clinical Research Executive Summary Background to postmarketing research Mandatory postmarketing trial requirements Phase IV trials for market development Impact of competitive pressures & pipeline strength on phase IV trials Appropriate trial design CONTENTS: Chapter 1 Background to postmarketing research Chapter 2 Mandatory postmarketing trial requirements Chapter 3 Phase IV trials for market development Chapter 4 Impact of competitive pressures and pipeline strength on phase IV trials Chapter 5 Effective phase IV trial design Chapter 6 Appendix FIGURES AND TABLES ALSO INCLUDED Products Mentioned: - Zyprexa - Diovan - Zoloft - Vioxx - Iressa - Novartis - Glivec (Imatinib mesylate) - Aclasta
Phase IV trials (Post Marketing Surveillance Trials) allow pharma to monitor the wider use of a new medicine with both patients and doctors after the medicine has received its license.
Increasingly regulatory authorities are demanding Phase IV trials to look at use in other populations not covered in the original trials - children and pregnant women - the effects of drug interaction and to detect any rare or long-term side effects.
Phase IV trials have become increasingly expensive and slow.
Phase IV trials will continue to grow at an estimated annual rate of over 20 percent.
Profiles of the leading companies active in microdosing (Phase 0), adaptive trials, Phase IV trials and information technology
From Phase I through to Phase IV trials, Afferenz's software and services are helping a global client roster that ranges from small biotechnology and medical device companies to industry-leading pharmaceutical companies and contract research organizations (CROs).
We were impressed with InForm's global deployment capabilities, its proven ability to scale from Phase I trials to Phase IV trials, and its breadth of functionality.