Course Information Section: 1 Schedule No.: 28291 Number of Units: 3 Time: 1600 – 1840 Meeting Days: Monday Location: sh236 Instructor




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НазваниеCourse Information Section: 1 Schedule No.: 28291 Number of Units: 3 Time: 1600 – 1840 Meeting Days: Monday Location: sh236 Instructor
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PH722: SEMINAR CLINICAL TRIALS

Fall, 2007


Course Information


Section: 1 Schedule No.: 28291 Number of Units: 3

Time:1600 – 1840 Meeting Days: Monday Location: SH236

Instructor


Name: Ming Ji, PhD

Associate Professor, Epi/Biostatistics

Graduate School of Public Health

San Diego State University

5500 Campanile Drive

San Diego, CA 92182-4162

Tel: 619-594-3454

Email: mji@mail.sdsu.edu

Office: HT230

Office Hours: 1400-1600 Monday or by appointment

Course Description


This seminar course is an introduction to the fundamental concepts and principles for the design, conduct, analysis and reporting of clinical trials and related statistical methods. Topics including: history of clinical trials, causal inference, study designs, randomization, blinding, sample size calculation, selection of control groups, ethics, interim analysis, statistical analysis of clinical trial data and interpretation of clinical trial results.

Prerequisite


Basic knowledge of epidemiology and biostatistics at the PH601 and PH602 levels are required. Knowledge of multivariate regression models such as multiple regression, analysis of covariance, logistic regression and survival analysis comparable to PH627 is recommended.


Course Objective


This course is aimed to familiarize the students with clinical trials, including their design, conduct, analysis and interpretation. Upon the completion of this course, the students should be able to

  • Identify the characteristics of clinical trials and differentiate clinical trials from other designs in clinical or epidemiological studies

  • Apply the principles to design clinical trials and write protocols

  • Calculate sample size required for study designs

  • Produce different randomization schemes

  • Specify data monitoring and interim analysis rules

  • Articulate the legal, ethical and regulatory issues in the design and review of clinical trials (such as IRB issues)

  • Understand appropriate statistical analysis methods for different types of clinical trial data

  • Interpret clinical trial findings appropriately

  • Critically review published clinical trial results



Teaching Format


Teaching will conducted by (1) classroom lecture by instructor and guest lecturers (2) assigned reading (3) in class representation and (4) online discussion (5) homework assignments (6) site visits to clinical trial study centers or pharmaceutical companies.


The students are expected to finish assigned reading materials before class, actively participate in lectures and online discussion, complete and turn in homework assignments in time and attend the site visits.

Evaluation and Grading


Attendance Attendance is very important since a single class meeting is 2 hours and 40 minutes. There will be no make-up lectures. Absence is only permitted for family emergency, necessary business trip and other legitimate reasons. The student who will miss a class meeting must inform the instructor prior to the class date. The instructor will deduct 10 points from a student’s attendance score for each missed class without legitimate reason.


Weekly Online Discussion There will also be 10 discussion topics on the Blackboard posted by the instructor. Each student is required to contribute at least three postings per topic with at least one original posting (new thread), at least two follow-up posting (comments on other people’s posting). The postings should not be just opinions. Postings should have your own point of view with supporting information or argument. They should reflect that the student has done research and analysis on the topic.


In-Class Presentation. Each student will be asked to give a presentation based on a topic in clinical trial he/she chooses. A separate list of possible topics will be available later. The order for the students to give presentation will be based on a sequence of random numbers but the fist student can choose a topic first and so on. Rescheduling is granted only under special circumstances. Each presentation should be about 30 minutes followed by a 10~15 minutes for questions and discussions. The presentation must be submitted to the instructor in electronic format after the presentation. The quality of the presentation will be based on peer-review by students as well as evaluation by the instructor on several aspects: your research on the topic such as how thorough is your literature review, your analysis of the topic such as whether you have insights, the quality of your presentation and how you respond to other people’s questions.


Homework. There will be ten homework assignments. They will be available on the day of lecture and due after one week. The file names should be in the format of Name_Assign_#.doc for example, Ming_Assign_1.doc The students can submit their answer online through the Digital Drop Box on Blackboard. Late assignments can only get partial credits if they are less than 10 days late with 1 point deducted for one day delay. No credits will be given 10 days after the due date.

Grades Breakdown

Discussions: 30x10=300

Assignments 30x10=300

Attendance: 10x14=140

Presentation: 360

Total: 1000


Letter Grades: 950+ A

900-950 A_

850-900 B

800-850 B_

700-800 C

600-700 D

<600 F


Textbooks


Required

Fundamentals of Clinical Trials. 3rd Edition by Lawrence M. Friedman, Curt D. Furberg and David L. DeMets. Springer Verlag, New York, Inc 1998.


References

1. Clinical Trials: A practical approach. Stuart J. Pocock. John Wiley & Sons Ltd.

1983

2. Clinical Trials, Design, Conduct and Analysis. Curtis L.Meinert, Oxford

University Press, 1986

3. Statistical Aspects of the Design and Analysis of Clinical Trials. Everitt B and

Pickels, A Imperial College, 2000

4. Sample Size Tables for Clinical Studies. 2nd Edition. MacHin D, Campbell M. J

and Favers P.M. Blackwell Science Inc. 1997

5. Multivariate Analysis: A Practical Guide for Clinicians. Katz M.H and Katz M.H.

Cambridge University Press. 1999

6. Analysis of Clinical Trials using SAS: A Practical Guide. Alex Dmitrienko,

Geert Molenberghs, Christy Chuang-Stein and Walter Offen


Computer and Internet Access

The students are required to have access to computers and Internet access for online discussions and submitting homework assignments. The SDSU Blackboard for this course will be available for enrolled students. Two online journals, Controlled Clinical Trials and Statistics in Medicine, are accessible online through SDSU library website. Links are provided on the Blackboard.


Cheating and Plagiarism

Cheating and plagiarism is strictly prohibited at SDSU. For definitions of cheating and plagiarism and SDSU’s policy, please visit http://its.sdsu.edu/turnitin/pdf/Plagiarism_AcadSen.pdf


Students with Disabilities

SDSU provides services to students with disabilities. For more information about SDSU’s Disabled Student Service, please visit: http://www.sa.sdsu.edu/dss/dss_home.html


Class Schedule





Dates

Topic

August 27

History and Introduction to Clinical Trials


Sue Hollander/ Health Sciences Librarian: Information sources for clinical trials. Assignment 1 Out.

Sept 10

Research Question/Study Population.

Assignment 1 Due. Assignment 2 Out.

Sept 17

Basic Study Designs.

Assignment 2 Due. Assignment 3 Out.

Sept 24

Randomization and Blindness.

Assignment 3 Due. Assignment 4 Out.

Oct 1

Ethics and Human Subject Projection.

Assignment 4 Due. Assignment 5 Out.

Oct 8

Baseline Assessment / Recruitment of Participants

Assignment 5 Due. Assignment 6 Out.

Oct 15

Adverse Events/Quality of Life Assessment/Sample Size Calculation.

Assignment 6 Due. Assignment 7 Out.

Oct 22

Survival Analysis and Interim Monitoring

Assignment 7 Due. Assignment 8 Out.

Oct 29

Data Collection/Data Analysis/Reporting and Interpreting of Results

Assignment 8 Due. Assignment 9 Out.

Nov 5

Student Presentation 1.

Assignment 9 Due. Assignment 10 Out.

Nov 19

Student Presentation 2

Assignment 10 Due.

Nov 26

Site Visit


Dec 3

Student Presentation 3



Course Schedule Subject to Change

This course schedule is subject to change if certain circumstances arise. If a student misses a class, it is his/her responsibility to check on potential changes in the class schedule.

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