MeSH

A work that reports on the results of a clinical study in which participants are assigned to receive one or more interventions so that researchers can evaluate the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. For clinical trials on veterinary animals see CLINICAL TRIAL, VETERINARY. Clinical Trials was used for both humans and non-humans prior to 2019.

Year introduced: 2008(1991)

Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.

Year introduced: 2008(1965)

A work that reports on a clinical trial involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicine, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trial is characterized as a RANDOMIZED CONTROLLED TRIAL.

Year introduced: 2008(1995)

A work in which animal participants are assigned to receive one or more interventions so that researchers can evaluate the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol.

Year introduced: 2019

A type of clinical study designed to evaluate the effectiveness of interventions in real-world health system practice.

Year introduced: 2014

Work that is a report of a planned post-marketing study of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale after clinical trials, phases I, II, and III. These studies, conducted in the United States or a foreign country, often garner additional data about the safety and efficacy of a product.

Year introduced: 2008(1993)

Work that is a report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques after phase II trials. A large enough group of patients is studied and closely monitored by physicians for adverse response to long-term exposure, over a period of about three years in either the United States or a foreign country.

Year introduced: 2008(1993)

Work that is a report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques based on several hundred volunteers, including a limited number of patients, and conducted over a period of about two years in either the United States or a foreign country.

Year introduced: 2008(1993)

Work that is the report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques based on a small number of healthy persons and conducted over the period of about a year in either the United States or a foreign country.

Year introduced: 2008(1993)

Works about the written descriptions of a clinical study. It contains the study's objectives, design, and methods including subject target and/or enrollment criteria. It may also present relevant scientific background and statistical information.

Year introduced: 2019

The written description of a clinical study. It contains the study's objectives, design, and methods including subject target and/or enrollment criteria. It may also present relevant scientific background and statistical information.

Year introduced: 2019

Clinical study in which a prospectively planned opportunity is included to modify trial designs and hypotheses based on analysis of data from subjects in the study.

Year introduced: 2018

Works about a study where participants are assigned to a treatment, procedure, or intervention by methods that are not random. Non-randomized clinical trials are sometimes referred to as quasi-experimental clinical trials or non-equivalent control group designs.

Year introduced: 2015

A quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc., with application chiefly in the areas of research and medicine.

Year introduced: 2008(1989)

Works about studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries.

Year introduced: 2008(1993)

Works about clinical studies in which animal participants are assigned to receive one or more interventions so that researchers can evaluate the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Animal participants may receive diagnostic, therapeutic, or other types of interventions.

Year introduced: 2019

Works about clinical studies in which a prospectively planned opportunity is included to modify trial designs and hypotheses based on analysis of data from subjects in the study.

Year introduced: 2018

The relationship between an elicited ADAPTIVE IMMUNE RESPONSE and the dose of the vaccine administered. It is typically measured in an assay to ensure proper dosing and storage of vaccines whereas VACCINE EFFICACY determines disease risk reduction attributable to vaccination under ideal conditions such as a clinical trial and vaccine immunogenicity measures vaccine's ability to induce an immune response in a vaccinated individual in observational studies setting.

Year introduced: 2014

Providing an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available. Compassionate use trials allow patients to receive promising but not yet fully studied or approved therapies when no other treatment option exists. Also called expanded access trial.

Year introduced: 2010

Works consisting of studies determining the effectiveness or utility of processes, personnel, and equipment.

Year introduced: 2008(2001)