Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the …
SP Ivy, LL Siu, E Garrett-Mayer, L Rubinstein - Clinical Cancer Research, 2010 - AACR
The goals and objectives of phase 1 clinical trials are changing to include further evaluation
of endpoints such as molecular targeted effects, in addition to dose-toxicity profile of the …
of endpoints such as molecular targeted effects, in addition to dose-toxicity profile of the …
The continual reassessment method for dose-finding studies: a tutorial
E Garrett-Mayer - Clinical trials, 2006 - journals.sagepub.com
The Continual Reassessment Method (CRM), along with other adaptive dose-finding study
designs, has gained popularity since its proposal by O'Quigley. Several of the reasons it has …
designs, has gained popularity since its proposal by O'Quigley. Several of the reasons it has …
BOIN12: Bayesian optimal interval phase I/II trial design for utility-based dose finding in immunotherapy and targeted therapies
PURPOSE For immunotherapy, such as checkpoint inhibitors and chimeric antigen receptor
T-cell therapy, where the efficacy does not necessarily increase with the dose, the maximum …
T-cell therapy, where the efficacy does not necessarily increase with the dose, the maximum …
[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 …
model-based experimental design with a strong emphasis on biopharmaceutical studies …
Dose-finding based on efficacy–toxicity trade-offs
We present an adaptive Bayesian method for dose-finding in phase I/II clinical trials based
on trade-offs between the probabilities of treatment efficacy and toxicity. The method …
on trade-offs between the probabilities of treatment efficacy and toxicity. The method …
[图书][B] Bayesian designs for phase I-II clinical trials
Y Yuan, HQ Nguyen, PF Thall - 2016 - api.taylorfrancis.com
Bayesian Designs for Phase I–II Clinical Trials Page 1 Page 2 Ying Yuan The University of
Texas MD Anderson Cancer Center Houston, Texas, USA Hoang Q. Nguyen The University of …
Texas MD Anderson Cancer Center Houston, Texas, USA Hoang Q. Nguyen The University of …
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 …
Bayesian model averaging continual reassessment method in phase I clinical trials
G Yin, Y Yuan - Journal of the American Statistical Association, 2009 - Taylor & Francis
The continual reassessment method (CRM) is a popular dose-finding design for phase I
clinical trials. This method requires that practitioners prespecify the toxicity probability at …
clinical trials. This method requires that practitioners prespecify the toxicity probability at …
An adaptive dose‐finding design incorporating both toxicity and efficacy
W Zhang, DJ Sargent, S Mandrekar - Statistics in medicine, 2006 - Wiley Online Library
Novel therapies are challenging the standards of drug development. Agents with specific
biologic targets and limited toxicity require novel designs to determine doses to be taken …
biologic targets and limited toxicity require novel designs to determine doses to be taken …
[图书][B] Clinical trial design: Bayesian and frequentist adaptive methods
G Yin - 2012 - books.google.com
A balanced treatment of the theories, methodologies, and design issues involved in clinical
trials using statistical methods There has been enormous interest and development in …
trials using statistical methods There has been enormous interest and development in …