A review of modern computational algorithms for Bayesian optimal design

EG Ryan, CC Drovandi, JM McGree… - International Statistical …, 2016 - Wiley Online Library
Bayesian experimental design is a fast growing area of research with many real‐world
applications. As computational power has increased over the years, so has the development …

Adaptive trial designs: a review of barriers and opportunities

JA Kairalla, CS Coffey, MA Thomann, KE Muller - Trials, 2012 - Springer
Adaptive designs allow planned modifications based on data accumulating within a study.
The promise of greater flexibility and efficiency stimulates increasing interest in adaptive …

Good practices in model‐informed drug discovery and development: practice, application, and documentation

EFPIA MID3 Workgroup, SF Marshall… - CPT …, 2016 - Wiley Online Library
This document was developed to enable greater consistency in the practice, application,
and documentation of Model‐Informed Drug Discovery and Development (MID3) across the …

[图书][B] Optimal design for nonlinear response models

VV Fedorov, SL Leonov - 2013 - books.google.com
Optimal Design for Nonlinear Response Models discusses the theory and applications of
model-based experimental design with a strong emphasis on biopharmaceutical studies …

[图书][B] Multiple testing problems in pharmaceutical statistics

A Dmitrienko, AC Tamhane, F Bretz - 2009 - books.google.com
Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical
industry, academia, and regulatory agencies, this volume explores the rapidly growing area …

Adaptive designs for confirmatory clinical trials

F Bretz, F Koenig, W Brannath, E Glimm… - Statistics in …, 2009 - Wiley Online Library
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 …

Model‐based dose finding under model uncertainty using general parametric models

J Pinheiro, B Bornkamp, E Glimm… - Statistics in medicine, 2014 - Wiley Online Library
The statistical methodology for the design and analysis of clinical Phase II dose‐response
studies, with related software implementation, is well developed for the case of a normally …

[HTML][HTML] Key design considerations for adaptive clinical trials: a primer for clinicians

K Thorlund, J Haggstrom, JJH Park, EJ Mills - bmj, 2018 - bmj.com
This article reviews important considerations for researchers who are designing adaptive
clinical trials. These differ from conventional clinical trials because they allow and even …

The future of drug development: advancing clinical trial design

J Orloff, F Douglas, J Pinheiro, S Levinson… - Nature reviews Drug …, 2009 - nature.com
Declining pharmaceutical industry productivity is well recognized by drug developers,
regulatory authorities and patient groups. A key part of the problem is that clinical studies are …

Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations

JS Gewandter, RH Dworkin, DC Turk, MP McDermott… - PAIN®, 2014 - Elsevier
Abstract Proof-of-concept (POC) clinical trials play an important role in developing novel
treatments and determining whether existing treatments may be efficacious in broader …