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STAT-735:
Design and Analysis of Clinical Trials (3 credits)
South
Dakota State University
(Fall 2007 Internet)
Course Meeting Time and Location: Sept. 5, 2007 - Dec. 21, 2007, Internet (WebCT delivered).
Contact Information:
Instructor: Dr. Weiming Ke
Office location: Harding Hall, Room 122
Office hours: Monday and Wednesday 10:00AM-12:00Noon or by appointment (made
through e-mail or phone)
Office phone number: (605)
688-6877
Email address: weiming.ke@sdstate.edu
More information about the instructor of this course can be found on http://teach.sdstate.edu/users/kew/
Communication Preference: WebCT email.
Course Description: Introduction to design, conduct,
and analysis of clinical trials. The course focuses mostly on the
comparative, also called Phase III, Randomized Clinical Trials (RCT). The
course is offered for students from any field that needs design and analysis
of clinical experiments.
Course Prerequisites: STAT-441/541
or STAT-482/582, or permission of the
instructor.
Course Content:
· Basic concepts of clinical trials
· Study design
· Randomization and blindness
· Sample size determination
· Data collection process
· Statistical analysis
· Survival analysis
Description of Instructional Methods:
Check the schedule (on the course content page). You should read the online
materials, the chapters in the textbook, and do the homework before the due
dates. Submit your homework as an attachment to an internal WebCT e-mail. If you have any questions, compose a
discussion message. If you can answer someone's questions, please do so, it
will help you to learn. I will answer all the existing questions every
Thursday afternoon starting at 3:00PM.
If you do not want others to see your questions, use the internal WebCT e-mail. I will check discussion questions and WebCT e-mail every weekday afternoon starting at 3:00PM.
Course Requirements:
1. Required textbook: Fundamentals of Clinical Trials, 3rd
edition, by Friedman, Furberg, and DeMets, Springer-Verlag,
New York, 1998. ISBN 0-387-98586-7. The
textbook may be purchased through the SDSU bookstore (http://www.sdstatebookstore.com).
2. Required technology: Access to a
computer with internet is needed for this course.
3. Technology support: For assistance with technology problems or
access to WebCT, contact the Help Desk at 605-688-6776.
WebCT Course User
Guidelines and WebCT 101: Learning with
WebCT are very helpful.
4. Class attendance policy: Login at least two times a week to read
the online materials and examples or to submit your homework.
5. Academic honesty policy: The instructor abides by the policies
endorsed by the SDSU administration. See SDSU Conduct Code 01:10:25 at http://studentaffairs.sdstate.edu/JudicialAffairs/StudentCode/Chapter10.pdf
6. Make-up policy: Each assignment and test should be submitted before
due dates. If there is an emergency please contact the instructor to make the
necessary arrangements for adjusting the due dates.
Course Goals:
Upon completion of this course, students will be able to demonstrate an
ability to design and conduct a clinical trial as well as to use basic
statistical methods to analyze the data from a clinical trial and interpret results.
Student Learning Outcomes:
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Outcomes
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Teach/Learning
activities
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Assessments
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Upon completion of this course students will be able to:
(1) Demonstrate their ability to describe, choose and apply appropriate study
designs for conducting clinical trials.
(2) Demonstrate their ability to conduct randomization and blinding for
clinical trials.
(3) Demonstrate their ability to calculate sample size for different
clinical trials involving dichotomous, continuous, or survival data.
(4) Demonstrate their ability to apply appropriate statistical methods to
analyze the data from clinical trials including dichotomous, continuous, or
survival data.
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Read online materials and the corresponding chapters on
the textbook. Ask questions and discuss questions actively. Search and read
relevant articles. Finish assigned homework and exams.
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Homework and exams
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How to Submit Homework and Tests: Homework and tests should be
submitted as an attachment to an internal WebCT
email.
Evaluation Procedures:
Assessments: All the homework, midterm exam, and one final exam will be
evaluated and contributed to the final grade.
Grading Policy:
- Homework
→ 30 PTS
- Mid
Term → 30 PTS
- Final
Exam → 40 PTS
- Total
Grade → 100 PTS
Grading Scale: 90-100 → A, 80-89 → B, 70-79 →
C, 60-69 → D, 0-59 → F
Disability Policy:
Any student needing accommodations based on the impact of a disability
should contact Nancy Hartenhoff-Crooks, Coordinator
of Disability Services, to develop an accommodation plan. She can be reached
by phone at 605-688-4504
or by e-mail at Nancy.Crooks@sdstate.edu,
or at the office in West Hall Room 110. Please discuss your needs with the
instructor as well.
Tentative Course Schedule: see
Tentative Exam Due Dates:
Mid Term: Oct. 26,
2007
Final Exam: Dec. 21, 2007
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