Adaptive dose finding based ont-statistic for dose–response trials

Adaptive designs for phase II cross-over dose-finding trials using Bayesian model averaging

Finding the right dose of a novel treatment is one of the most important tasks in early drug development. However, there is often uncertainty about the form of the relationship between dose and patient response at the time that the dose-finding trials are designed. In this presentation we develop Bayesian adaptive designs for Phase II cross-over trials conducted to estimate the minimum effectiv...

Bayesian Adaptive Dose-finding Based on Efficacy and Toxicity

A description of the conventional paradigm for early phase clinical evaluation of a new agent is given, followed by a list of this paradigm’s logical and practical flaws. This is provided initially to motivate the use of phase I-II clinical trial designs. The main body of the paper consists of a review of several practical Bayesian phase I-II designs for sequentially adaptive dose-finding based...

A modified toxicity probability interval method for dose-finding trials.

BACKGROUND Building on earlier work, the toxicity probability interval (TPI) method, we present a modified TPI (mTPI) design that is calibration-free for phase I trials. PURPOSE Our goal is to improve the trial conduct and provide more effective designs while maintaining the simplicity of the original TPI design. METHODS Like the TPI method, the mTPI consists of a practical dose-finding sch...

Dose-finding Designs for Phase Ii Clinical Trials

Stochastic Approximation and Modern Model-based Designs for Dose-Finding Clinical Trials.

In 1951 Robbins and Monro published the seminal paper on stochastic approximation and made a specific reference to its application to the "estimation of a quantal using response, non-response data". Since the 1990s, statistical methodology for dose-finding studies has grown into an active area of research. The dose-finding problem is at its core a percentile estimation problem and is in line wi...