C1; C3; I1 </AbstractSection> Copyright Härkänen et al.; licensee Springer. 2013

We consider a dose-finding trial in phase IIB of drug development. For choosing an appropriate design for this trial the specification of two points is critical: an appropriate model for describing the dose-effect relationship and the specification of the aims of the trial (objectives), which...

An important health policy issue is the low rate of patient enrollment into clinical trials, which may slow down the process of clinical trials and discourage their supply, leading to delays in innovative life-saving drug treatments reaching the general population. In the US, patients’ cost of...

Risk factor models in clinical epidemiology are important for identifying individuals at high risk of poor health outcomes and for guiding intervention strategies to reduce risk. Such models are often based on generalised linear models (GLM) with a multiplicative risk, rate or odds assumption....

Composite endpoints are often used as primary efficacy endpoints, particularly in the field of oncology and cardiology. These endpoints combine several time-to-event variables of interest within a single time-to-first-event variable. Thereby, it is intended to enlarge the expected effect size...

Composite endpoints are increasingly used in clinical trials, particularly in the field of cardiology. Thereby, the overall impact of the therapeutic intervention is captured by including several events of interest in a single variable. To demonstrate the significance of an overall clinical...

Usually patients are allowed to switch their treatments in clinical trials out of an ethical consideration. This complicates the modeling of the trial, as well as the analyzing process of the collected data. For group-parallel clinical trials which contain two groups (one is the test and the...