phase IV trial


Also found in: Dictionary, Thesaurus, Legal, Encyclopedia.
Related to phase IV trial: phase 2 clinical trial

phase IV trial

, phase 4 trial
A clinical trial to examine long-term effectiveness and adverse effects that might occur from a treatment after the Food and Drug Administration has approved its use by the public. Such trials, involving thousands or tens of thousands of enrollee patients, are either mandated by regulatory authorities or undertaken voluntarily by a pharmaceutical manufacturer once the drug has gone to market. Often it is only in Phase IV trials that especially rare adverse effects emerge. Enrollee patients in a clinical trial should have the approval of their personal oncologist, and they should seek a second opinion (which is covered by insurance) to obtain more input on what trials to consider.
See also: trial
References in periodicals archive ?
Pfizer, a biopharmaceutical company, has revealed top-line results from a double-blind Phase IV trial of Lyrica (pregabalin) Capsules CV to treat adolescents aged 12-17 years with fibromyalgia, it was reported on Friday.
M2 PHARMA-March 16, 2015-Pfizer reveals top-line results from double-blind Phase IV trial of Lyrica Capsules
17%), according to the findings of a phase IV trial of medications that were already approved for this intended use.
Evaluation of real-time effectiveness of the drug and availability of a facility to conduct trials in state-of-the-art settings, thus complementing the outcomes of premarketing randomised control trials, are the prime benefits availed from pharmacovigilance in phase IV trials.
Additionally, companies conducting Phase IV trials are seeking to establish effectiveness in order to outshine competitors.