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Randomized phase II cancer clinical trials /
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....
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken :
CRC Press,
2013.
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| Colección: | Chapman & Hall/CRC biostatistics series.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 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.