Franz Koenig

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Traditional drug development consists of a sequence of independent trials organized in different phases. Full development typically involves (i) a learning phase II trial and (ii) one or two confirmatory phase III trial(s). For example, in the phase II trials several doses of the new compound might be compared to a control and/or placebo with the goal of(More)
The purpose of this study was to analyze statistically the test-retest and inter-chart reliability of three standardized Radner Reading Charts with respect to reading acuity, maximum reading speed, critical print size and LogRAD/LogMAR ratio and to quantitatively identify the sources of variability. At two testing sessions (3 to 4 weeks apart), 36(More)
The Model for End-Stage Liver Disease (MELD) is widely used to predict the short-term mortality in patients with cirrhosis, but potential limitations of this score have been reported. The aim of this study was to improve the score's prognostic accuracy by assessing new objective variables. Data of 310 consecutive patients with cirrhosis who underwent(More)
There is increasing evidence from ecological studies that lithium levels in drinking water are inversely associated with suicide mortality. Previous studies of this association were criticized for using inadequate statistical methods and neglecting socioeconomic confounders. This study evaluated the association between lithium levels in the public water(More)
Inadequate selection of the dose to bring forward in confirmatory trials has been identified as one of the key drivers of the decreasing success rates observed in drug development programs across the pharmaceutical industry. In recognition of this problem, the Pharmaceutical Research and Manufacturers of America (PhRMA), formed a working group to evaluate(More)
BACKGROUND Few risk factors and indicators of vulnerability for suicide in custody are known so far. AIMS A case-control study was conducted to investigate the relevance of criminal history, psychiatric morbidity and social integration to suicide in prison. METHOD For every suicide that occurred in an Austrian correctional institution between 1975 and(More)
Adaptive designs play an increasingly important role in clinical drug development. Such designs use accumulating data of an ongoing trial to decide how to modify design aspects without undermining the validity and integrity of the trial. Adaptive designs thus allow for a number of possible adaptations at midterm: Early stopping either for futility or(More)
To identify factors associated with success of Market Authorisation Applications (MAAs) for pharmaceutical drugs submitted to the European Medicines Agency (EMEA), with an emphasis on the Scientific Advice (SA) given by the Committee for Human Medicinal Products (CHMP). MAAs with a CHMP decision (outcome) between 1 January 2004 and 31 December 2007 were(More)
Integrating selection and confirmation phases into a single trial can expedite the development of new treatments and allows to use all accumulated data in the decision process. In this paper we review adaptive treatment selection based on combination tests and propose overall adjusted p-values and simultaneous confidence intervals. Also point estimation in(More)
This study aims to provide a quantitative analysis of the factors affecting the actual precision and stability of optoelectronic and electromagnetic tracking systems in computer-aided surgery under real clinical/intraoperative conditions. A "phantom-skull" with five precisely determined reference distances between marker spheres is used for all(More)