Browsing Programa de Doctorat en Estadística i Investigació Operativa by Subject "57"

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Composite endpoints in clinical trials : computational tools, practical guidelines and methodological extensions

Gómez-Mateu, Moisés (Date of defense: 2016-06-30)

The conclusions from randomized clinical trials (RCT) rely on the primary endpoint (PE), which is chosen at the design stage of the study; thus, it is of utmost importance to select it appropriately. In RCT, there should ...

Measuring review report quality in health research : development and validation of ARCADIA

Superchi, Cecilia (Date of defense: 2021-01-21)

Editorial peer review is the gateway to scientific publication. It was established to ensure that research papers were vetted by independent experts before they are published. Despite the importance of this process, its ...

Proposing some innovative study design features to regulatory agencies (EMA and FDA) in bioequivalence trials : Reference Scaled Average Bioequivalence, and Two-Stage Adaptive Designs

Molins Lleonart, Eduard (Date of defense: 2021-05-28)

In applications for generic medicinal products the concept of bioequivalence is fundamental. Two medicinal products, i.e. a test and a reference drugs containing the same active substance are considered bioequivalent if ...

Statistical methods and software for clinical trials with binary and survival endpoints : efficiency, sample size and two-sample comparison

Bofill Roig, Marta (Date of defense: 2020-12-22)

Defining the scientific question is the starting point for any clinical study. However, even though the main objective is generally clear, how this is addressed is not usually straightforward. Clinical studies very often ...