Spitzer-Index, Instrumental Activities of Daily Living Scale (IADL), EORTC QLQ-C30,-LC13 Booton R et al. (2006) [13] Clinical trial, III NSCLC III/IV Docetaxel/Carboplatin vs. Mitomycin C/Cisplatin/Vinblastine vs. Ifosfamide/Cisplatin secondary No superiority of one regimen.
However, for all secondary endpoints where superiority of the PCT group is the objective, we believe these biases to be conservative.
Accordingly, the hypotheses H3 and H4 would then denote the comparison of the same two doses with a control, for either a secondary endpoint, a superiority claim, or a pre-specified subgroup.
Potential randomized phase II or III studies could use the PCRT as either a primary (phase I/II safety assessment) or secondary (phase III superiority or equivalence trial) endpoint.
The testing procedures outlined in the above examples – 1) CV noninferiority → CV superiority → secondary endpoints (eg, microvascular) or 2) CV noninferiority → secondary endpoints (eg, micro-vascular) → CV superiority – are all mathematically valid, but do not make logical sense.
Some secondary outcomes hinted at superiority of the combination during acute phase treatment.
The secondary end point was superiority with regard to a lower incidence of adverse events.
This has demonstrated that DRV/r was non-inferior to LPV/r and the secondary statistical analysis suggested superiority of DRV/r in this setting.
We therefore believe that there is an advantage to designing a non-inferiority trial, which would assume non-inferiority for neurological outcome but test superiority for secondary measures.
Although it might currently be possible to envision superiority on secondary endpoints such as relative tolerability (e.g., colistin may be needed as part of current comparison regimens and its nephrotoxicity might provide an avenue to a demonstration of superiority), this approach will become decreasingly feasible as new agents are developed.
