2887

Friedman, Lawrence M,author

5th ed. 2015.

1 online resource (XXI, 550 pages 49 illustrations, 7 illustrations in color.)

Introduction to Clinical Trials -- Ethical Issues -- What is the Question? -- Study Population -- Basic Study Design -- The Randomization Process -- Blinding -- Sample Size -- Baseline Assessment -- Recruitment of Study Participants -- Data Collection and Quality Control -- Assessment and Reporting of Harm -- Assessment of Health Related Quality of Life -- Participant Adherence -- Survival Analysis -- Monitoring Committee Structure and Function -- Statistical Methods Used in Interim Monitoring -- Issues in Data Analysis -- Closeout -- Reporting and Interpreting of Results -- Multicenter Trials -- Regulatory Issues

DeMets, David L, , Furberg, Curt D, , Granger, Christopher B, , Reboussin, David M,