Due to the fact that ethics approval was not needed for this quality improvement project, no power situation occurred (faculty interviewed faculty); no sensitive information was gathered and to accommodate the busy schedules of clinical physicians, this was deemed to be a fair indication of their approval.
Data derived from controlled clinical trials form the prerequisite on which the status of approval, the approved indications and also the availability of a certain substance may prompt the treating physician to consider it within his or her repertoire based on his or her available knowledge and experience in the diagnosis, treatment and assessment of RA.
We collected the following information: name of the active substance, year of approval, indication, design of the pivotal trials, number of patients in each trial, primary and secondary end points supporting the approval and difference in survival between arms, when available.
Moreover, although therapeutic gain was a low probability, early indications of activity were indeed observed with many agents, some of which led to eventual indications for approval.
Instead, we assessed the supporting clinical evidence for all supplemental indications at the time of approval by accessing the earliest FDA drug label in the Drugs@FDA database that mentioned the newly approved use.
As the first non-hormonal alternative to estrogen-based products for this indication, the approval of ospemifene represents a significant milestone in postmenopausal women's health.
By contrast, similar rates of clinical outcome endpoints were used by efficacy trials forming the basis of approval for new indication supplements and those supporting originally approved indications (32% (44/137) versus 39% (78/202); P=0.22) (table 4).
So, if a party packed with praise-filled editors and Jay-Z's stamp of approval are any indication of the show's potential for success, then June most certainly has a hit.
Clinical outcomes were most often used in trials supporting supplemental indication approvals of neurologic (11/23; 48%) and infectious disease drugs (20/44; 45%); by contrast, 70% (56/80) of oncology supplemental indications were supported exclusively by trials using surrogate outcomes (table 4).
We then compared the evidence supporting the new uses with that providing the basis of approval for these agents' original indications.
