Adaptive seamless phase II/III clinical trial designs allowing treatment selection at an interim analysis have gained much attention because of their potential benefits compared to more conventional drug development programmes with separate trials for individual phases. A scenario of particular...

Longitudinal clinical trials are often plagued by nonmonotone missingness due to both patient dropout and intermittent missingness. Standard analysis assumes that missingness is ignorable. Because the assumption can be questionable, the sensitivity of inferences to alternative assumptions about...

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

To explore and compare attitudes of consumers (patients and their family members) and medical staff toward clinical trials related to mental health in China, we developed two questionnaires for medical staff and patients and their family members. Approximately 66.2% of medical staff who had no...

It is often argued that drug companies do not wish to carry out post-approval head-to-head clinical trials, since their drugs may be revealed as being no better than existing drugs. However, we show that standard models for vertical differentiation predicts that pharmaceutical companies would in...

In this note we outline 15 years of Gynecologic Oncology Group (GOG) experience conducting a series of phase II second-line intraperitoneal trials in the treatment of ovarian cancer. Using this information, the goal is to define a new permutation approach to historical control phase II trials in...

In this note, we address the problem of surrogacy using a causal modelling framework that differs substantially from the potential outcomes model that pervades the biostatistical literature. The framework comes from econometrics, and it conceptualizes direct effects of the surrogate endpoint on...

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...

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...