Twenty‐five years of confirmatory adaptive designs: opportunities and pitfalls

P Bauer, F Bretz, V Dragalin, F König… - Statistics in …, 2016 - Wiley Online Library
'Multistage testing with adaptive designs' was the title of an article by Peter Bauer that
appeared 1989 in the German journal Biometrie und Informatik in Medizin und Biologie. The …

[图书][B] Methods and applications of sample size calculation and recalculation in clinical trials

M Kieser - 2020 - Springer
This book provides an extensive overview of the principles and methods of sample size
calculation and recalculation in clinical trials. Appropriate calculation of the required sample …

Probabilistic foundation of confirmatory adaptive designs

W Brannath, G Gutjahr, P Bauer - Journal of the American …, 2012 - Taylor & Francis
Adaptive designs allow the investigator of a confirmatory trial to react to unforeseen
developments by changing the design. This broad flexibility comes at the price of a complex …

Conditional power and friends: The why and how of (un) planned, unblinded sample size recalculations in confirmatory trials

K Kunzmann, MJ Grayling, KM Lee… - Statistics in …, 2022 - Wiley Online Library
Adapting the final sample size of a trial to the evidence accruing during the trial is a natural
way to address planning uncertainty. Since the sample size is usually determined by an …

Maximum inflation of the type 1 error rate when sample size and allocation rate are adapted in a pre‐planned interim look

AC Graf, P Bauer - Statistics in medicine, 2011 - Wiley Online Library
We calculate the maximum type 1 error rate of the pre‐planned conventional fixed sample
size test for comparing the means of independent normal distributions (with common known …

[图书][B] Statistical Thinking in Clinical Trials

MA Proschan - 2021 - taylorfrancis.com
Statistical Thinking in Clinical Trials combines a relatively small number of key statistical
principles and several instructive clinical trials to gently guide the reader through the …

Familywise error control in multi-armed response-adaptive two-stage designs

G Gutjahr, M Posch, W Brannath - Journal of biopharmaceutical …, 2011 - Taylor & Francis
For comparing multiple treatments against a single control with normally distributed
observations, we consider two-stage designs of the following form: During the first stage …

Sample size re-estimation

T Mütze, T Friede - Handbook of Statistical Methods for …, 2021 - taylorfrancis.com
Determining the sample size is an essential part of planning a clinical trial that needs to
balance ethical, financial, scientific, and statistical power consideration that are often of …

Adaptive group sequential designs with control of the population-wise error rate

C Hillner - 2021 - media.suub.uni-bremen.de
The aim of individualized medicine is to provide each patient with a therapy tailored to his or
her genetic profile. This is particularly important in diseases where the efficacy of a treatment …

Adaptive Group Sequential Tests

G Wassmer, W Brannath, G Wassmer… - Group Sequential and …, 2016 - Springer
If the prior experience with the study treatments is insufficient for a persistent pre-
specification of relevant and realistic treatment effects, the effect and corresponding sample …