Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger.
Fifth edition.
xxi, 550 pages :
illustrations ;
25 cm
Includes bibliographical references and index.
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 & Function -- Statistical Methods Used in Interim Monitoring -- Issues in Data Analysis -- Closeout -- Reporting and Interpreting of Results -- Multicenter Trials -- Regulatory Issues.