Clinical Trial - Work that is the report of a pre-planned clinical study of the safety, efficacy, or optimum dosage schedule of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in humans selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. While most clinical trials concern humans, this publication type may be used for clinical veterinary articles meeting the requisites for humans. Specific headings for specific types and phases of clinical trials are also available. Indexing Annotation: this heading is used as a Publication Type; for original report of the conduct or results of a specific clinical trial; a different heading ‘clinical trials as topic’ is used for general design, methodology, economics, etc. of clinical trials |
Controlled Clinical Trial - Work consisting of 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 a control treatment, the trial is characterized as a ‘randomized controlled trial’ - Indexing Annotation: this heading is used as a Publication Type; for original report of the conduct or results of a specific controlled clinical trial; a different heading ‘controlled clinical trials as topic’ is used for general design, methodology, economics, etc. of clinical trials. |
Randomized Controlled Trial - Work consisting of a clinical trial that involves at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table. Indexing Annotation: this heading is used as a Publication Type; for original report of the conduct or results of a specific randomized controlled trial; a different heading ‘randomized controlled trials as topic’ is used for general design, methodology, economics, etc. of randomized controlled trials. |
Clinical Trial Phase I* - 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. |
Clinical Trial Phase II* - 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. |
Clinical Trial Phase III* - 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. |
Clinical Trial Phase IV* - 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. |