He pooled data from two much larger ongoing studies of Vytorin and said they showed that the cancer risk was a statistical fluke.
Lilly, however, noted that a pre-specified secondary analysis of pooled data showed statistically significant slowing of cognitive decline in patients with mild-to-moderate disease who were treated with its solanezumab compound.
And pre-specified secondary subgroup analyses of pooled data across both studies showed a statistically significant slowing of cognitive decline in patients with mild disease, but not in those with moderate disease.
In 2008, geneticist David Craig showed that he was able to trace pooled genetic data that was available online back to an individual who had participated.
Pooled analyses of Avandia clinical trial data, she noted, pointed to more heart attacks occurring on Avandia than on either the placebo or with its main competitor, Actos, which is made by Takeda.
Milton Packer of the University of Texas, Southwestern, pointed out that if the available data on Simdax is pooled, the drug appears to have a neutral effect on the length of patients lives, and may actually extend them.
Such publication commonly leads to urgent calls to take immediate regulatory action, without acknowledgment of potential pitfalls in the interpretation of data from meta-analyses and pooled analyses, such as those encountered in the tiotropium evaluation.
Safety data for KYNAMRO are based on pooled results from four Phase 3, randomized, double-blind, placebo-controlled trials with a total of 390 patients of which 261 patients received weekly subcutaneous injections of 200 mg of KYNAMRO and 129 patients received placebo for a median treatment duration of 25 weeks.
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