Statistical thinking for non-statisticians in drug regulation /
Richard Kay.
- Second edition.
- xxii, 346 pages : illustrations ; 26 cm.
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.
9781118470947 RM 355.08 111847094X
Clinical Trials as Topic--methods. Drug Approval. Drug industry. Statistics as Topic.