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.
References in periodicals archive ?
The Phase IIb study will aim at demonstrating efficacy of nangibotide and bring a clinically relevant proof of clinical activity in septic shock patients.
This three-year Phase IIB Bridge SBIR (Small Business Innovation Research) federal funds was granted by the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH) under Award No.
The company expects to report completion of recruitment by mid-2014 and 12-week topline data from the Phase IIb programme in the fourth quarter of 2014.
The phase IIb clinical study is presented as a poster.
Patients for the Phase IIb study will be selected based on having genotype 1 chronic HCV and having failed to respond to pegylated alpha interferon plus ribavirin therapy (non-responders).
As a result, GSK has decided to terminate Phase IIB studies in HIV-positive patients who have never taken any AIDS drug.
uniQure announced initial clinical data in patients treated in the company's Phase IIb dose-confirmation study of AMT-061, an investigational AAV5-based gene therapy containing a patent-protected FIX-Padua variant, for the treatment of patients with severe and moderately severe hemophilia B.
M2 EQUITYBITES-August 22, 2018-CytoSorbents wins up to USD3m SBIR Phase IIB Bridge funding for its HemoDefend blood transfusion filter
The $3.3m total raised is projected to provide funding to complete implants in the Phase IIb clinical trial of NTCELL for Parkinsons disease which commenced on 24 March.
(SeeNews) - Jun 13, 2013 - Belgian biopharmaceuticals company UCB (EBR:UCB) announced today new data from an open-label extension of its Phase IIb study with epratuzumab for the treatment of systemic lupus erythematosus (SLE).
20 May 2011 - Swedish pharma company Medivir AB (STO:MVIR B) announced today positive 48-week interim data from a Phase IIb clinical trial with candidate drug TMC435 for the treatment of hepatitis C virus (HCV) genotype-1 (G1).
Tokyo, Japan, Sept 6, 2005 - (JCNN) - Sosei, a Japanese biopharmaceutical company, announced on September 5 that its wholly owned UK subsidiary Arakis has started a phase IIb dose-ranging study of AD 452, an investigational drug for the treatment of rheumatoid arthritis (RA).