clinical trial

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Related to Drug trial: phase 1 clinical trial

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 ?
There has been an increase in clinical trials open to recruitment, currently over 50, and there has been an increase in referrals and patients going on to drug trials. Last year, (August 2017-August 2018) there were 2,183 patient visits to the centre.
For the first time all North Queenslanders will have access to the latest drug trials from national and international trial groups and companies, he said.
It seems like a lot of people in your drug trials have been diagnosed with rheumatoid arthritis, so can you tell us what the disease is?
"Our eDiary solutions are designed to make compliance simpler for drug trial participants," said Jeff Albrecht, president of Arrowhead Electronic Healthcare.
FDA is responsible for oversight of clinical drug trials and deciding whether to approve new drugs for marketing in the United States.
The outcome of Greenberg's participation underscores the fact that investigators' pursuit of volunteers for drug trials, which often leads to maximizing symptoms in the face of an imprecise diagnostic formulary, can contribute to overly inclusive misdiagnoses and thus an extraordinarily high placebo response rate in conditions otherwise known for their response to active treatment.
Hayley's mother Kerry, from Bexhill, East Sussex, is hoping the drug trial at Boston's Children's Hospital next week will lead on to the premature ageing process stopping.
As in the case of clinical drug trials, it is possible to describe the impact of the environment in terms of discretely defined variables that are connected to the larger goals of critical care.
The concept paper describes a process in which a test would be established and analytically validated during Phase I and Phase II drug studies and clinically validated during Phase III drug trials. However, device and drug manufacturers say this is unrealistic.
A HUMAN guinea pig who had a lucky escape in the 'Elephant Men' drug trial says that the group of men are considering legal action.
Needs first met Richards at a drug trial in 1977 so has years of exclusive interviews to draw upon in his survey of a changing, eventful life.
The pharmaceutical industry has long been loathe to reveal negative drug trial information because it can hurt stock prices and create a competitive disadvantage.