Twenty‐five years of confirmatory adaptive designs: opportunities and pitfalls
'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 …
appeared 1989 in the German journal Biometrie und Informatik in Medizin und Biologie. The …
Methods for identification and confirmation of targeted subgroups in clinical trials: a systematic review
Important objectives in the development of stratified medicines include the identification and
confirmation of subgroups of patients with a beneficial treatment effect and a positive benefit …
confirmation of subgroups of patients with a beneficial treatment effect and a positive benefit …
[BOK][B] Multiple comparisons using R
Adopting a unifying theme based on maximum statistics, Multiple Comparisons Using R
describes the common underlying theory of multiple comparison procedures through …
describes the common underlying theory of multiple comparison procedures through …
The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an …
Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without
compromising the validity of conclusions and it is essential to distinguish pre-planned from …
compromising the validity of conclusions and it is essential to distinguish pre-planned from …
[BOK][B] Multiple testing problems in pharmaceutical statistics
Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical
industry, academia, and regulatory agencies, this volume explores the rapidly growing area …
industry, academia, and regulatory agencies, this volume explores the rapidly growing area …
[HTML][HTML] A randomized adaptive phase II/III study of buparlisib, a pan-class I PI3K inhibitor, combined with paclitaxel for the treatment of HER2–advanced breast cancer …
M Martín, A Chan, L Dirix, J O'Shaughnessy, R Hegg… - Annals of oncology, 2017 - Elsevier
ABSTRACT Background Phosphatidylinositol 3-kinase (PI3K) pathway activation in
preclinical models of breast cancer is associated with tumor growth and resistance to …
preclinical models of breast cancer is associated with tumor growth and resistance to …
An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints
M Jenkins, A Stone, C Jennison - Pharmaceutical statistics, 2011 - Wiley Online Library
Although the statistical methods enabling efficient adaptive seamless designs are
increasingly well established, it is important to continue to use the endpoints and …
increasingly well established, it is important to continue to use the endpoints and …
Adaptive designs for confirmatory clinical trials
Adaptive designs play an increasingly important role in clinical drug development. Such
designs use accumulating data of an ongoing trial to decide how to modify design aspects …
designs use accumulating data of an ongoing trial to decide how to modify design aspects …
Maintenance defactinib versus placebo after first-line chemotherapy in patients with merlin-stratified pleural mesothelioma: COMMAND—a double-blind, randomized …
PURPOSE Inhibition of focal adhesion kinase has been shown to selectively kill
mesothelioma cells that express low levels of moesin-ezrin-radixin-like protein (merlin). On …
mesothelioma cells that express low levels of moesin-ezrin-radixin-like protein (merlin). On …
Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs
Adaptive designs for clinical trials permit alterations to a study in response to accumulating
data in order to make trials more flexible, ethical, and efficient. These benefits are achieved …
data in order to make trials more flexible, ethical, and efficient. These benefits are achieved …