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In documents released ahead of the panel meeting, F.D.A. staff members said interim data analysis showed patients who were implanted with the disk did as well as patients who were treated with spinal fusion.
Adaptive trial designs use interim data analysis to amend trials, and have been recognized for more than a decade as a way to increase trial efficiency, partly by the increased probability of demonstrating a drug effect if one exists.
The interim data analysis after five CLP runs showed futility of the n = 10 goal for DIE mice at the 96 h time point (due to low late mortality) as well as acceptable data distribution and variability for the pre-96 h time points.
Postmenopausal women (both surgically and naturally) with HSDD and increased risk for CV events will be followed up for up to 5 years postrandomization with an interim data analysis for regulatory approval after the last woman enrolled has been on therapy for at least 12 months.
There has been no interim data analysis until this study protocol was submitted.
The DMEC will undertake an interim data analysis to detect any reason for halting the trial.
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Setting Five NHS acute hospital and mental health trusts that have been the focus of early implementation efforts and at which interim data collection and analysis are complete.
Through a process of data analysis, interim prioritisation and final workshops, a top 10 or 11 research questions have been identified for 12 categories of eye conditions.
The conditional type 1 error for rejecting at least one treatment-control comparison in the final analysis, given the interim data, can be calculated as follows In the final analysis after the second stage each test (comparing treatment i to the control group) is based on the following global test statistic: where,,, have independent standard normal distributions.
A recent geographical analysis of interim data from this study, which included a European-only sample and data from only six treatment cycles, reported similar results and conclusions overall (Castellano et al, 2009).
In a previous publication, further analysis of interim data from this trial showed that baseline QoL (including FKSI-15 scores) was a significant predictor of PFS, even after other prognostic variables (e.g., treatment and key demographic and clinical variables) were added to the model (Cella et al, 2009).
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