Box 6.3.b: US National Library of Medicine 2008 definitions for the Publication Type terms ‘Randomized Controlled Trial’ and ‘Controlled Clinical Trial’

Randomized Controlled Trial

Work consisting of a clinical trial that involves at least one test treatment and one control treatment, concurrent enrolment 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.

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 control treatments, the trial is characterized as a ‘Randomized Controlled Trial’.