phase IV trial


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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
Medical Dictionary, © 2009 Farlex and Partners
References in periodicals archive ?
Midatech Pharma plc (AIM: MTPH) (Nasdaq: MTP) has enrolled the first patient in its Gelclair Phase IV trial in stem cell transplant (SCT), the pharmaceutical company said on Friday.
Finally, a study completed after marketing has been approved is a Phase IV trial, which examines new indications, dosing strategies, new patient populations, and quality of life.
James Ferrendelli of the University of Texas Health Science Center, Houston, reported on a prospective phase IV trial involving 78 patients older than 65 with partial seizures.
M2 PHARMA-June 8, 2018-Midatech launches Phase IV trial of treatment for OM in stem cell transplant patients
ASCENT is a double-blind, randomised, placebo-controlled, parallel-group, Phase IV trial aimed at evaluating the effect of Tudorza on time to first major adverse cardiovascular event (MACE) and reduction of moderate or severe exacerbations in patients with moderate to very severe COPD.
Data Source: Randomized, investigator-blinded, phase IV trial of 247 patients with moderate acne.
The open-label, multicenter, observational phase IV trial also showed significant improvement among Hispanic patients with acne, compared with their white counterparts, reported Dr.
It seems that PhRMA members will probably be able to reach a consensus for publishing information on Phase III and Phase IV trial of marketed products, but unlikely to endorse a plan that publishes the results of Phase II or earlier studies.