Subject: STA 225
Title: Clinical Trials
Units: 4.0
School: College of Letters and Science LS
Department: Statistics STA
Effective Term: 2005 Spring
Learning Activities
- Lecture - 3.0 hours
- Discussion/Laboratory - 1.0 hours
Description
Basic statistical principles of clinical designs, including bias, randomization, blocking, and masking. Practical applications of widely-used designs, including dose-finding, comparative and cluster randomization designs. Advanced statistical procedures for analysis of data collected in clinical trials.
Prerequisites
STA 223 or BST 223; or Consent of Instructor.
Enrollment Restrictions
Suppress CRN in Schedule.
Cross Listed
Same course as BST 225.
Expanded Course Description
Summary of Course Content:
ETHICAL CONSIDERATIONS - covers Historical and Modern Perspectives, and Professional Ethics. BASICS OF DESIGNING CLINICAL TRIALS - Design Concepts, Clinical Trial Design Types, and Bayesian View. BIAS AND RANDOM ERRORS - Random Errors, and Clinical and Statistical Biases. OBJECTIVES AND ENDPOINTS - Objectives and Endpoints in Different Trials. SAMPLE SIZE, POWER AND STUDY COHORT - Relation Between Power And Sample Size, Sample Size For Different Trials, and Simulations. DATA-DEPENDENT STOPPING - Likelihood, Frequentist and Bayesian Methods. TREATMENT ALLOCATION - Types of Randomization for Treatment Allocation. ANALYSIS OF DATA COLLECTED IN CLINICAL TRIALS - Statistical Methods Used for Analysis of Data Collected in Clinical Trials.
REPORTING - Quality and Contents of Clinical Trial Reports, and Authorship. SPECIAL DESIGNS - Factorial Designs, Cross-Over Designs, and Sequential Designs. CLUSTER RANDOMIZATION - Historical Development, Planning a Cluster Randomization Trial, and Sample Size and Power. ANALYSIS OF DATA COLLECTED IN CLINICAL TRIALS - Statistical Methods for Analysis of Cluster Randomized Data.
Illustrative Reading:
The course material is extracted from a variety of sources, including journals such as Biometrics, Biometrika, Statistics in Medicine, Applied Statistics, and the New England Journal of Medicine. Relevant reference books are: Buyse, Staquet, and Sylvester (Eds.). Cancer Clinical Trials. Oxford University Press, 1986. Donner and Klar. Design and Analysis of Cluster Randomization Trials in Health Research. Arnold, 2000. Piantadosi, S. Clinical Trials: A Methodological Perspective. Wiley, 1997.
Potential Course Overlap:
None