Titlebook: Developments in Statistical Evaluation of Clinical Trials; Kees van Montfort,Johan Oud,Wendimagegn Ghidey Book 2014 Springer-Verlag Berlin

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Mindfulness in Behavioral Healthharmacokinetic exposure-response relationship and (2) dose-response relationship when dose-adjustment depends on potential responses. Dose adjustment often happens in clinical trials either designed for therapeutic dose monitoring, or spontaneously due to, for example, adverse events. It makes causa

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Realistic Random Direction Mobilityrement. For a continuous outcome variable, a classical GLM for repeated measurements can be used to analyse the difference in development over time between the intervention and control group. However, because GLM for repeated measurements has some major disadvantages (e.g., only suitable for complet

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Handbook of Mobile Data Privacycal trials. However, failed past attempts to use surrogate endpoints made it clear that, before deciding on the use of a candidate surrogate endpoint, it is of the utmost importance to investigate its validity. Such validation process has proven challenging for conceptual and practical reasons. In t

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Handbook of Mobile Data Privacycularly, in oncology. This chapter provides an overview of various biomarker-based designs for phase III randomized clinical trials to evaluate clinical utility of a biomarker or biomarker-based treatment, including biomarker-strategy, enrichment, and randomize-all designs. We also provide a simulat

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Handbook of Mobile Teaching and Learning such as the continual reassessment method (CRM), have been gradually applied to single-agent trials to determine the maximum tolerated dose (MTD). By contrast, the rule-based approaches have commonly been applied to two-agent combination trials, probably due to the absence of well-understood model-

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Handbook of Mobile Teaching and Learningally in first or second line of cancer therapies. Basic formulae for the determination of sample sizes based on time to event data can be found in the literature. Assumptions about the distributions of the survival time for OS and PFS, the accrual time and the censoring time are of key importance. M

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Marcello Farina,Riccardo Scattolinid as the dose associated with a certain probability of dose limiting toxicity (DLT) during the first cycle of treatment, although toxicity is repeatedly measured over cycles on an ordinal scale. We present the main dose finding methods developed in the era of cytotoxic agents. We illustrate their pr