Sarah Zohar

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The aim of a phase I oncology trial is to identify a dose with an acceptable safety profile. Most phase I designs use the dose-limiting toxicity, a binary endpoint, to assess the unacceptable level of toxicity. The dose-limiting toxicity might be incomplete for investigating molecularly targeted therapies as much useful toxicity information is discarded. In(More)
The aim of dose-ranging phase I (resp. phase II) clinical trials is to rapidly identify the maximum tolerated dose (MTD) (resp., minimal effective dose (MED)) of a new drug or combination. For the conduct and analysis of such trials, Bayesian approaches such as the Continual Reassessment Method (CRM) have been proposed, based on a sequential design and(More)
BACKGROUND Most statistical design and analysis methods for clinical trials have been developed and evaluated where at least several hundreds of patients could be recruited. These methods may not be suitable to evaluate therapies if the sample size is unavoidably small, which is usually termed by small populations. The specific sample size cut off, where(More)
In this paper, we present the dfcomb R package for the implementation of a single prospective clinical trial or simulation studies of phase I combination trials in oncology. The aim is to present the features of the package and to illustrate how to use it in practice though different examples. The use of combination clinical trials is growing, but the(More)
Pilot studies and other small clinical trials are often conducted but serve a variety of purposes and there is little consensus on their design. One paradigm that has been suggested for the design of such studies is Bayesian decision theory. In this article, we review the literature with the aim of summarizing current methodological developments in this(More)
BACKGROUND Randomized controlled trials (RCTs) are the gold standard design of clinical research to assess interventions. However, RCTs cannot always be applied for practical or ethical reasons. To investigate the current practices in rare diseases, we review evaluations of therapeutic interventions in paediatric multiple sclerosis (MS) and(More)
Although visual short-term memory (VSTM) has been studied extensively, the majority of this literature has focused on the impact of 2-D stimulus properties. Studies of the effects of binocular disparity on VSTM have drawn conflicting conclusions due to design and stimulus differences. To reassess the impact of stereopsis on VSTM we used a novel paradigm in(More)
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