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On Estimands and the Analysis of Adverse Events in the Presence of Varying Follow-up Times Within the Benefit Assessment of Therapies
Abstract: The analysis of adverse events (AEs) is a key component in the assessment of a drug's safety profile. Inappropriate analysis methods may result in misleading conclusions about a therapy's safety and consequently its benefit-risk ratio. The statistical analysis of AEs is complicated by the fact that the follow-up times can vary between the patients included in a clinical trial. This paper takes as its focus the analysis of AE data in the presence of varying follow-up times within the benefit assessment of therapeutic interventions. Instead of approaching this issue directly and solely from an analysis point of view, we first discuss what should be estimated in the context of safety ...
Survival Analysis for AdVerse Events with VarYing Follow-up Times (SAVVY): Rationale and Statistical Concept of a Meta-analytic Study
Abstract: The assessment of safety is an important aspect of the evaluation of new therapies in clinical trials, with analyses of adverse events being an essential part of this. Standard methods for the analysis of adverse events such as the incidence proportion, that is the number of patients with a specific adverse event out of all patients in the treatment groups, do not account for both varying follow-up times and competing risks. Alternative approaches such as the Aalen-Johansen estimator of the cumulative incidence function have been suggested. Theoretical arguments and numerical evaluations support the application of these more advanced methodology, but as yet there is to our knowledg...
Patient-Reported Outcomes
Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for biopharmaceutical researchers and others in the healt
German Medical Data Sciences 2022 - Future Medicine: More Precise, More Integrative, More Sustainable!
The aim of medical research has always been to gain scientific knowledge which will serve to improve the diagnosis, therapy and prevention of diseases. It is also becoming increasingly important to take account of the changing circumstances of medical care. Factors such as the ageing of society and the recent pandemic have not only led to greater use of medical care, but have also put the human resources and infrastructural basis of the health system under great pressure. Such developments call for science-based solutions which can better adapt medical action to the needs of patients to ensure that medicine remains affordable and accessible for all. This book is the 6th volume of the German ...
German Medical Data Sciences: Bringing Data to Life
The COVID-19 pandemic has brought into sharp focus the need for the collection of data. Such data cannot be collected or provided without medical informatics, documentation and health data management. Nor can health data be evaluated and converted into a useful tool for making the important decisions that affect us all without biometrics and epidemiology, bioinformatics and systems biology. This book presents full papers from GMDS & CEN-IBS 2020, the first joint online conference of the German Association of Medical Informatics, Biometry and Epidemiology (GMDS) and the Central European Network & the International Biometric Society (CEN-IBS), held online between 6 and 11 September 2020. The t...
Handbuch Methoden der Organisationsforschung
Das Handbuch verschafft einen umfassenden Überblick über die quantitativen und qualitativen Methoden der Organisationsforschung. Die übergreifende Struktur, die durchgängige Herangehensweise und der hohe Praxisbezug versetzen Wissenschaftler, Studierende und insbesondere Praktiker in die Lage, das Methodeninstrumentarium der Organisationsforschung gezielt für eigene Zwecke zu nutzen.
Quantitative Methoden Der Organisationsforschung
Dieses Handbuch verschafft einen Überblick über die quantitativen Methoden der Organisationsforschung. Befragungen, Beobachtungsmethoden, Simulation und Modellierung, Experiment und Planspiel sowie verschiedene Analysemethoden werden im Detail dargestellt. Der Schwerpunkt der Beiträge liegt auf der ausführlichen Beschreibung der Datenerhebung und der Dateninterpretation. Ein Beispiel aus der Praxis der empirischen Organisationsforschung verdeutlicht die Vorgehensweise. In einem eigenen Abschnitt über die Möglichkeiten und Grenzen der jeweiligen Methode wird auf potenzielle Fallstricke hingewiesen. Die übergreifende Struktur, die durchgängige Herangehensweise und der hohe Praxisbezug versetzen Wissenschaftler und Studierende aber auch Praktiker in die Lage, das Methodeninstrumentarium der quantitativen Organisationsforschung gezielt für eigene Zwecke einzusetzen und weiterzuentwickeln.
