TY  - BOOK
AU  - Kay,R.
TI  - Statistical thinking for non-statisticians in drug regulation
SN  - 9781118470947
PY  - 2015///
CY  - Chichester, West Sussex, UK
PB  - John Wiley & Sons Inc.
KW  - Clinical Trials as Topic
KW  - methods
KW  - Drug Approval
KW  - Drug industry
KW  - Statistics as Topic
N1  - Includes bibliographical references and index; Basic ideas in clinical trial design -- Sampling and inferential statistics -- Confidence intervals and p-values -- Tests for simple treatment comparisons -- Adjusting the analysis -- Regression and analysis of covariance -- Intention-to-treat and analysis sets -- Power and sample size -- Statistical significance and clinical importance -- Multiple testing -- Non-parametric and related methods -- Equivalence and non-inferiority -- The analysis of survival data -- Interim analysis and data monitoring committees -- Bayesian statistics -- Adaptive designs -- Observational studies -- Meta-analysis -- Methods for the safety analysis and safety monitoring -- Diagnosis -- The role of statistics and statisticians
ER  -