clinical trial

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Related to Phase IIb: phase 2 clinical trial, double dummy

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 ?
The Phase IIb trial is a randomised, placebo-controlled, multicentre study (IFN-K-002) in systematic lupus erythematosus (LES).
The purpose of this Phase IIb trial is to measure the efficacy and safety of BC-819 at a dose of 20mg.
In conjunction, the primary objective of this Phase IIb trial is to evaluate the efficacy of MIN-101 compared to placebo in improving the negative symptoms of schizophrenic patients over 12 weeks of treatment.
Avexa is preparing SPD754 to enter a Phase IIb trial designed to demonstrate its efficacy in HIV-infected patients that have demonstrated resistance to therapy with 3TC (Lamivudine), a first line HIV therapy.
Epiphany Biosciences, Medivir's partner on valomaciclovir (MIV-606), presented positive results from its phase IIb trial on shingles patients.
The randomised double-blinded placebo-controlled Phase IIb trial had three parallel groups in which patients were given FOLFOX chemotherapy for up to eight treatment cycles and either PledOx at a dose of two umol/kg, five umol/kg or placebo.
Phase IIb Extension Study Reaches 96 Week Milestone
M2 EQUITYBITES-October 29, 2014-Akebia Therapeutics reports positive top-line results from Phase IIb placebo-controlled trial of AKB-6548
M2 PHARMA-October 29, 2014-Akebia Therapeutics reports positive top-line results from Phase IIb placebo-controlled trial of AKB-6548
TSX: MBI; OTC: MGIXF), Vancouver, a developer of anti-infective drugs, achieved statistically and clinically significant efficacy results from its Phase IIb study of MBI 594AN, a topical drug candidate under development as a first-in-class prescription treatment for acne.
Food and Drug Administration (FDA) providing clarification on the FDA's decision to place on clinical hold the Company's Phase IIb trial with arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).
M2 PHARMA-October 15, 2014-Tobira Therapeutics starts dosing in Phase IIb clinical trial of cenicriviroc