Spring 2017 Course Syllabus: Math 654
Course Title: 
Design and Analysis of
Clinical Trials 
Textbook: 
Clinical Trial Design: Bayesian and Frequentist Adaptive Methods , by Guosheng Yin; Publisher: Wiley; 1 edition (January, 2012); ISBN10: 0470581719, ISBN13: 9780470581711 
Prerequisites: 
Math 665 or equivalent with
Departmental approval. 
Course
Outline 

Date 
Lecture 
Sections 
Topic 
Assignment 
Week 1 1/23 
1 
Lecture Notes

Introduction to Epidemiology 
Homework 1 
Week 2 1/30 
2 
Chapter 1 and Lecture Notes 
Introduction to Clinical Trials 

Week 3 2/6 
3 
Chapter 4 and Lecture Notes 
Phase I Clinical Trials 
Homework 2 
Week 4 2/13 
4 
Chapter 5 and Lecture Notes 
Phase II Clinical Trials 

Week 5 2/20 
5 
Chapter 2 and Lecture Notes 
Phase III Clinical Trials 
Homework 3 
Week 6 2/27 
6 
Chapter 7 and Lecture Notes 
Randomization 

Week 7 3/6 
7 
Sections 6.16.3 and Lecture Notes 
Sample Size Calculations 
Homework 4 
Week 8 3/13 


Spring Recess No
Classes Scheduled 

Week 9 3/20 


MIDTERM EXAM: Monday ~ March 20, 2017 

Week 10 3/27 
8 
Section 6.6 and Lecture Notes 
Group Sequential Methods (I) 

Week 11 4/3 
9 
Lecture Notes 
Group Sequential Methods (II) 
Homework 5 
Week 12 4/10 
10 
Lecture Notes

Multiple Comparisons Procedures (I) 

Week 13 4/17 
11 
Lecture Notes 
Multiple Comparisons Procedures (II) 
Homework 6 
Week 14 4/24 
12 
Section 6.7 and Lecture Notes 
Adaptive Design (I) 

Week 15 5/1 

Lecture Notes 
Adaptive Design (II)


Week 16 5/8 


FINAL EXAM: Monday ~ May 8, 2017 

IMPORTANT
DATES 

FIRST DAY OF SEMESTER 
January 17, 2017 
LAST DAY TO WITHDRAW 
March 27, 2017 
LAST DAY OF CLASSES 
May 2, 2017 
FINAL EXAM PERIOD 
May 5 – 11, 2017 
Grading Policy
Assignment Weighting 

Tentative Grading Scale 

Homework 
30 % 

A 
90  100 
Midterm Exam 
30 % 

B+ 
85  89 
Final Exam 
40 % 

B 
80  84 



C+ 
75  79 



C 
70  74 



F 
0  69 
Important Departmental and University
Policies
Prepared by Prof. Wenge Guo, December 20, 2016