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Author Jung, Sin-Ho.
Title Randomized phase II cancer clinical trials / Sin-Ho Jung.
Imprint Hoboken : CRC Press, 2013.


 Internet  Electronic Book    AVAILABLE
Description 1 online resource (236 pages).
Series Chapman & Hall/CRC Biostatistics Series
Chapman & Hall/CRC biostatistics series.
Bibliog. Includes bibliographical references.
Note Available only to authorized UTEP users.
Print version record.
Subject Clinical trials -- Statistical methods.
Cancer -- Research -- Statistical methods.
Neoplasms -- therapy.
Clinical Trials, Phase II as Topic.
Randomized Controlled Trials as Topic.
Research Design.
Statistics as Topic.
Contents Introduction Single-Arm Phase II Trial Designs; Single-Stage Designs; Two-Stage Designs; Two-Stage Designs with Both Upper and Lower Stopping Values Inference on the Binomial Probability in Single-Arm Multistage Clinical Trials; Point Estimation; Confidence Intervals; P-Values; When Realized Sample Size Is Different from That Specified in Design Single-Arm Phase II Clinical Trials with Time-to-Event Endpoints; A Test Based on Median Survival Time; Maximum Likelihood Method for Exponential Distribution; One-Sample Log-Rank Test; Two-Stage Trials Using One-Sample Log-Rank Test; Binomial Testing on t -Year Survival Probability Single-Arm Phase II Trials with Heterogeneous Patient Populations: Binary and Survival Outcomes; Binary Outcome Case; Survival Outcome Case: Stratified One-Sample Log-Rank Test Randomized Phase II Trials.
For Selection: No Prospective Control Arms; With a Historical Control; When No Historical Control Exists; Extension to More Than Two Arms Randomized Phase II Cancer Clinical Trials with a Prospective Control on Binary Endpoints (I): Two-Sample Binomial Test; Two-Sample Binomial Test; Two-Stage Designs with Both Upper and Lower Stopping Values; Discussions Randomized Phase II Cancer Clinical Trials with a Prospective Control on Binary Endpoints (II): Fisher's Exact Test; Single-Stage Design; Two-Stage Design; Extensions; Discussions Randomized Phase II Trials with Heterogeneous Patient Populations: Stratified Fisher's Exact Test; Single-Stage Stratified Fisher's Exact Test; Two-Stage Designs with an Interim Futility Test Randomized Phase II Clinical Trials Based on Survival Endpoints: Two-Sample Log-Rank Test; Two-Sample Log-Rank Test; Two-Stage Log-Rank.
Test; Stratified Two-Sample Log-Rank Test for Single-Stage Designs Some Flexible Phase II Clinical Trial Designs; Comparing Survival Distributions under General Hypothesis Testing; Randomized Phase II Trials for Comparing Maintenance Therapies Index References appear at the end of each chapter.
Summary In cancer research, a traditional phase II trial is designed as a single-arm trial that compares the experimental therapy to a historical control. This simple trial design has led to several adverse issues, including increased false positivity of phase II trial results and negative phase III trials. To rectify these problems, oncologists and biostatisticians have begun to use a randomized phase II trial that compares an experimental therapy with a prospective control therapy.
Other Title Print version: Jung, Sin-Ho. Randomized phase II cancer clinical trials. Hoboken : CRC Press, 2013 9781439871850