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Math 654: Design and Analysis of Clinical Trials
Spring 2018 Graduate Course Syllabus

NJIT Academic Integrity Code: All Students should be aware that the Department of Mathematical Sciences takes the University Code on Academic Integrity at NJIT very seriously and enforces it strictly. This means that there must not be any forms of plagiarism, i.e., copying of homework, class projects, or lab assignments, or any form of cheating in quizzes and exams. Under the University Code on Academic Integrity, students are obligated to report any such activities to the Instructor.

Course Information

Course Description: Statistical methods and issues in the design of clinical trials and analysis of their data. Topic include clinical trial designs for phases 1-4, randomization principle and procedures, analysis of pharmacokinetic data for bioequivalence, multi-center trials, categorical data analysis, survival analysis, longitudinal data analysis, interim analysis, estimation of sample size and power, adjustment for multiplicity, evaluation of adverse events, and regulatory overview. Effective From: Fall 2007.

Number of Credits: 3

Prerequisites: Math 665 or equivalent with Departmental approval.

Course-Section and Instructors

Course-Section Instructor
Math 654-102 Professor W. Guo

Office Hours for All Math Instructors: Spring 2018 Office Hours and Emails

Required Textbooks:

Title Clinical Trial Design: Bayesian and Frequentist Adaptive Methods
Author Guosheng Yin
Edition 1st
Publisher Wiley
ISBN # 978-0470581711

University-wide Withdrawal Date:The last day to withdraw with a w is Monday, April 2, 2018. It will be strictly enforced.


DMS Course Policies: All DMS students must familiarize themselves with, and adhere to, the Department of Mathematical Sciences Course Policies, in addition to official university-wide policies. DMS takes these policies very seriously and enforces them strictly.

Grading Policy: The final grade in this course will be determined as follows:

Homework 25%
Project 20%
Midterm Exam 25%
Final Exam 30%

Your final letter grade will be based on the following tentative curve.

A 90 - 100 C+ 75 - 79
B+ 85 - 89 C 70 - 744
B 80 - 84 F 0 - 69

Attendance Policy: Attendance at all classes will be recorded and is mandatory. Please make sure you read and fully understand the Math Department’s Attendance Policy. This policy will be strictly enforced.

Exams: There will be one midterm exam held in class during the semester and one comprehensive final exam. Exams are held on the following days:

Midterm Exam March 19, 2018
Final Exam Period May 4 - 10, 2018

The final exam will test your knowledge of all the course material taught in the entire course. Make sure you read and fully understand the Math Department's Examination Policy. This policy will be strictly enforced.

Makeup Exam Policy: To properly report your absence from a midterm or final exam, please review and follow the required steps under the DMS Examination Policy found here:

Cellular Phones: All cellular phones and other electronic devices must be switched off during all class times.

Additional Resources

Accommodation of Disabilities: Disability Support Services (DSS) offers long term and temporary accommodations for undergraduate, graduate and visiting students at NJIT.

If you are in need of accommodations due to a disability please contact Chantonette Lyles, Associate Director of Disability Support Services at 973-596-5417 or via email at The office is located in Fenster Hall, Room 260.  A Letter of Accommodation Eligibility from the Disability Support Services office authorizing your accommodations will be required.

For further information regarding self identification, the submission of medical documentation and additional support services provided please visit the Disability Support Services (DSS) website at:

Important Dates (See: Spring 2018 Academic Calendar, Registrar)

Date Day Event
January 16, 2018 T First Day of Classes
January 22, 2018 M Last Day to Add/Drop Classes
March 11 - 18, 2018 Su - Su Spring Recess - No Classes/ University Closed
March 30, 2018 F Good Friday - No Classes/ University Closed
April 2, 2018 M Last Day to Withdraw
May 1, 2018 T Friday Classes Meet - Last Day of Classes
May 2 - 3, 2018 W - R Reading Days
May 4 - 10, 2018 F - R Final Exam Period

Course Outline

Date Lecture Sections Topic Assignment
Week 1
1 Lecture Notes Introduction to Epidemiology Homework 1
Week 2
2 Chapter 1 and Lecture Notes Introduction to Clinical Trials
Week 3
3 Chapter 4 and Lecture Notes  Phase I Clinical Trials Homework 2
Week 4
4 Chapter 5 and Lecture Notes Phase II Clinical Trials
Week 5
5 Chapter 2 and Lecture Notes  Phase III Clinical Trials Homework 3
Week 6
6 Chapter 7 and Lecture Notes  Randomization
Week 7
7 Sections 6.1-6.3 and  Lecture Notes Sample Size Calculations Homework 4
Week 8
Spring Recess- No Classes Scheduled
Week 9
MIDTERM EXAM: Monday ~ March 19, 2018
Week 10
8 Section 6.6 and Lecture Notes  Group Sequential Methods (I) Clinical Trials Project
Week 11
9 Lecture Notes  Group Sequential Methods (II) Homework 5
Week 12
10 Lecture Notes Multiple Comparisons Procedures (I)
Week 13
11 Lecture Notes  Multiple Comparisons Procedures (II) Homework 6
Week 14
12 Section 6.7 and Lecture Notes Introduction to Adaptive Design
Week 15
Students’ Project Presentation
Week 16
FINAL EXAM: Monday ~ May 7, 2018

Updated by Professor W. Guo - 1/18/2018
Department of Mathematical Sciences Course Syllabus, Spring 2018