Sentence examples for pivotal trial data from inspiring English sources

Thus, the more skeptical one is based on the prior information, the harder it is to conclude efficacy using the same pivotal trial data.

We now turn our attention to patients with AS and a review of some of the early and pivotal trial data with these agents.

All three 6-month LA formulations fulfilled the efficacy and safety criteria for the registration in countries of submission based on their pivotal trial data.

In this case, we start from the published pivotal trial data because no full details of the Continued Access trial were provided by the study sponsor.

Pooled analyses of pivotal trial data were conducted to further assess how topiramate 100 mg/d affects daily activities and patient functioning.

In the past this finding of "comparable efficacy" was supported by indirect treatment comparisons 14 of the pivotal trial data; 15– 18 head-to-head evidence 19, 20 confirms these indirect estimates (Table 1).

Case studies 2a and 2b were considered to have a "high impact" on the regulatory decision framework, because they pertain to an analysis of pivotal clinical trial data that would affect the drug label.

After the publication of the pivotal trial results, additional data from the PARTNER trial became available.

A key strength of this analysis is that it utilises updated efficacy data derived from the IMPACT pivotal trial and as much UK-specific data as possible.

To compare the study population of the HICARE trial with the data of the pivotal trial by Bonner et al. [ 11, 12], descriptive statistical methods without formal testing will be used.

Determination of an appropriate methodology to estimate survival benefit in the ASC/BSC treatment group was largely driven by the aim of maintaining the integrity of the clinical trial data from the pivotal study (Cunningham et al, 2004).