Spring 2020 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); ISBN-10: 0470581719, ISBN-13: 978-0470581711

Prerequisites:

Math 665 or equivalent with Departmental approval.

 

 

Course Outline

Date

Lecture

Sections

Topic

Assignment

Week 1

1/27

1

 

Lecture Notes

 

Introduction to Epidemiology

Homework 1

Week 2

2/3

2

Chapter 1 and Lecture Notes

Introduction to Clinical Trials

 

Week 3

2/10

3

Chapter 4 and Lecture Notes 

Phase I Clinical Trials

Homework 2

Week 4

2/17

4

Chapter 5 and Lecture Notes

Phase II Clinical Trials

 

Week 5

2/24

5

Chapter 2 and Lecture Notes 

Phase III Clinical Trials

Homework 3

Week 6

3/2

6

Chapter 7 and Lecture Notes 

Randomization

 

Week 7

3/9

7

Sections 6.1-6.3 and  Lecture Notes

Sample Size Calculations

Homework 4

Week 8

3/16

 

 

Spring Recess- No Classes Scheduled

 

Week 9

3/23

 

 

MIDTERM EXAM:

Monday ~ March 23, 2020

 

Week 10

3/30

8

Section 6.6 and Lecture Notes 

Group Sequential Methods (I)

Clinical Trials Project

Week 11

4/6

9

Lecture Notes 

Group Sequential Methods (II)

Homework 5

Week 12

4/13

10

Lecture Notes

 

Multiple Comparisons Procedures (I)

 

Week 13

4/20

11

Lecture Notes 

Multiple Comparisons Procedures (II)

Homework 6

Week 14

4/27

12

Section 6.7 and Lecture Notes

Introduction to Adaptive Design

 

Week 15

5/4

 

 

Students’ Project Presentation

 

 

Week 16

5/11

 

 

FINAL EXAM:

Monday ~ May 11, 2020

 

 

 

 

 

IMPORTANT DATES

FIRST DAY OF SEMESTER

January 21, 2020

LAST DAY TO WITHDRAW

April 6, 2020

LAST DAY OF CLASSES

May 5, 2020

FINAL EXAM PERIOD

May 8 – 14, 2020

 

Grading Policy

 

Assignment Weighting

 

Tentative Grading Scale

Homework

25 %

 

A

90 -- 100

Project

15 %

 

B+

85 -- 89

Midterm Exam

25 %

 

B

80 -- 84

Final Exam

35%

 

C+

75 -- 79

 

 

 

C

70 -- 74

 

 

 

F

0 -- 69

 

 

 

Important Departmental and University Policies

 

 

Prepared by Prof. Wenge Guo, January 13, 2020