Adaptive Design Methods in Clinical TrialsCRC Press, 16 Nov 2006 - 296 halaman Although adaptive design methods are flexible and useful in clinical research, little or no regulatory guidelines are available. One of the first books on the topic, Adaptive Design Methods in Clinical Trials presents the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures |
Isi
CHAPTER 1 Introduction | 1 |
CHAPTER 2 Protocol Amendment | 23 |
CHAPTER 3 Adaptive Randomization | 47 |
CHAPTER 4 Adaptive Hypotheses | 75 |
CHAPTER 5 Adaptive DoseEscalation Trials | 89 |
CHAPTER 6 Adaptive Group Sequential Design | 107 |
CHAPTER 7 Adaptive Sample Size Adjustment | 137 |
CHAPTER 8 Adaptive Seamless Phase IIIII Designs | 161 |
CHAPTER 9 Adaptive Treatment Switching | 173 |
CHAPTER 10 Bayesian Approach | 195 |
CHAPTER 11 Clinical Trial Simulation | 211 |
CHAPTER 12 Case Studies | 239 |
| 255 | |
| 269 | |
Back cover | 279 |
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Adaptive Design Methods in Clinical Trials Shein-Chung Chow,Mark Chang Pratinjau tidak tersedia - 2006 |
Istilah dan frasa umum
achieve active actual adaptive design adjusted allocation allows analysis and/or applied approach assessment assigned assume Bayesian bias calculation changes Chapter clinical trials combination commonly comparing conditional conduct considered continue defined desired determine difference discussed distribution dose level drug early effect efficacy endpoint equal error estimated example expected flexible function futility given group sequential increase independent indicated interim analysis margin maximum mean methods modifications non-inferiority normal Note null hypothesis observed obtained optimal outcomes p-value parameters phase placebo planned practice predictive primary prior probability procedures proportion proposed protocol amendments randomization referred reject respectively response rate result rule sample sample size seamless selection simulation stage standard Step stopping boundaries subjects superiority switch Table target patient population test statistic test treatment tion treat treatment effect treatment groups trial design usually utility values variability