TY  - BOOK
AU  - Yuan,Ying
AU  - Nguyen,Hoang Q.
AU  - Thall,Peter F.
TI  - Bayesian designs for phase I-II clinical trials
T2  - Chapman & Hall/CRC biostatistics series 
SN  - 9781498709552 
U1  - 000SB:615.5 23
PY  - 2016///
CY  - Boca Raton : 
PB  - CRC Press, 
KW  - Clinical trials
KW  - Statistical methods
KW  - Drugs
KW  - Testing
KW  - Bayesian statistical decision theory
N1  - Includes bibliographical references and index; 1. Why conduct phase I-II trials? --
 2. The phase I-II paradigm --
 3. Establishing priors --
 4. Efficacy : toxicity trade-off-based designs --
 5. Designs with late-onset outcomes --
 6. Utility-based designs --
 7. Personalized dose finding --
 8. Combination trials --
 9. Optimizing molecularly targeted agents --
 10. Optimizing doses in two cycles --
 11. Optimizing dose and schedule --
 12. Dealing with dropouts --
 13. Optimizing intra-arterial tPA --
 14. Optimizing sedative dose in preterm infants
N2  - This book describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes.
The first two chapters minimize the technical language to make them accessible to non-statisticians. These chapters discuss the severe drawbacks of the conventional paradigm used for early-phase clinical trials and explain the phase I–II paradigm for optimizing dose, or more general treatment regimes, based on both efficacy and toxicity. The remainder of the book covers a wide variety of clinical trial methodologies, including designs to optimize the dose pair of a two-drug combination, jointly optimize dose and schedule, identify optimal personalized doses, optimize novel molecularly targeted agents, and choose doses in two treatment cycles
ER  -