Biostatistics for Clinical Investigators, Fall 2014
Course Overview
Course Goals:
To be able to:
1) Determine which statistical tests are appropriate for data analyses in most clinical studies
2) Perform and interpret statistical analyses using common statistical tests/methods, including sample size and power
calculations
3) Recognize when complex (eg, regression) analyses are indicated; be able to discuss these analyses with biostatistical
consultants
4) Recognize errors and limitations of published statistical analyses
5) Present data analyses clearly with appropriate conclusions and interpretations
Course Structure:
Weekly lectures and in-class problem solving
Weekly homework assignments (cumulative)
Use the Stata 13 statistical package
Show all work including the statistical program output when applicable.
You may discuss the homework with others but you are expected to complete your own assignments.
Three take-home exams (cumulative)
Use the Stata 13 statistical package
Show all work including the statistical program output when applicable.
You may use books, notes and other written references, but you are expected to complete your own test
without help from others.
Requirements for Credit:
1) Enrolling in the class for credit (email deborah.garcia@uth.tmc.edu)
2) Completion of the Stata online tutorial (https://med.uth.edu/pediatrics/crebm/clinical-research-education/crca-computercourse)
3) Attendance at all 14 lectures (may be viewed on videostream - must email Deb Garcia after viewing videostream
(https://med.uth.edu/pediatrics/crebm/clinical-research-education/clinical-research-curriculum/ - see instructions at
bottom of page) to get credit for “attendance”
4) Completion of all homework assignments and tests within 2 weeks after the date assigned (see exception below for
final), unless prior arrangements have been made in writing (by email) with Dr. Kennedy (must have email
verification of receipt from Deb)
5) Average score of at least 80% on the three take-home exams
6) Completion of the final exam and all other coursework by 12/19/14 [unless permission granted in writing (email) in
advance by Kathleen Kennedy]. Note: last test will be given on 12/10/14.
Course Directors:
Kathleen A. Kennedy, MD, MPH
(713) 500-6708
kathleen.a.kennedy@uth.tmc.edu
Charles Green, PhD
(713) 500-6402
charles.green@uth.tmc.edu
Claudia Pedroza, PhD
713 500-5721
claudia.pedroza@uth.tmc.edu
Clinical Research Curriculum Course Schedule:
Biostatistics for Clinical Investigators
DATE
SESSION
TOPIC
LECTURER
9/3/14
9/10/14
1
2
Kathleen Kennedy
Kathleen Kennedy
9/17/14
3
9/24/14
4
10/1/14
10/8/14
10/15/14
5
6
7
10/22/14
8
10/29/14
11/5/14
9
10
11/12/14
11/19/14
11
12
11/26/14
12/3/14
13
12/10/14
14
Types of Data, Summarizing Data
Principles of Statistical Analysis
and Hypothesis Testing
Comparing Two or More Groups Continuous Data
Comparing Two Groups Categorical Data
Review and Test
Survival Analysis
Interim/Sequential Analysis and
Sample Size
Simple Regression and Measures
of Association
Review and Test
Confounding and Interaction Matched and Stratified Analyses
Multiple Regression 1
Multiple Regression 2 and Other
Multivariate Techniques
Thanksgiving Break
Bayesian Approaches (including
Diagnostic Tests)
Review and Test
Kathleen Kennedy
Kathleen Kennedy
Kathleen Kennedy
Charles Green
Charles Green
Charles Green
CHAPTER: PAGES
(Dawson/Trapp)
3: 24-42, 4: 76-90
3: 50-53, 4: 62-75, 5: 94-114
5: 114-118, 121-125, 6: 135-146,
7: 163-175, 182-185
5: 119-121, 6: 146-154,
8: 200-201
9: 222-242, 10: 264-267
5: 125-131, 6: 154-158,
7: 185-186
3: 47-50, 53-58,
8: 191-200, 201-216
Charles Green
Kathleen Kennedy
7: 175-182
Claudia Pedroza
Claudia Pedroza
10: 246-255
10: 255-264
Claudia Pedroza
5: 118-119
12: 303-311, 313-315
Claudia Pedroza
Course Textbook:
Dawson B, Trapp RG. Basic and clinical biostatistics. 4th edition. Lange Medical Books/McGraw Hill, 2004.
Clinical/epidemiologic approach to biostatistics, lots of examples and exercises, all from clinical medicine/research.
Includes student version of NCSS and PASS software as well as data sets on CD-ROM. Available at UT Bookstore or on
Amazon.com for $55.91.
Course Software:
Stata (at least version 11) is required for coursework. Stata 13 is strongly recommended for those who plan to take the
advanced course. Stata is available at discounted pricing for students and faculty teaching in the University of Texas
system as follows.
FOR STUDENTS ONLY (student ID not required but must use .edu email address)
------------Stata/IC 13 - $69.00/six month license
Small Stata 13 - (can only accommodate smaller data sets, adequate for the Introductory course but not the Advanced
courses) - $35.00/six month license
FOR STUDENTS AND FACULTY (must use .edu email address)
-------------------Stata/IC 13 - $189.00/perpetual license
For more information about products: http://www.stata.com/products/whichstata.html
To order: http://www.stata.com/order/new/edu/gradplans/gp-direct.html
Be sure to include your .EDU email address when ordering.
Suggested Other Reading (General Statistics):
Altman DG, Machin D, Bryant TN, Gardner TN. Statistics with confidence 2 nd ed. BMJ Publishing, 2000. Excellent
reference for calculating, using, and interpreting confidence intervals.
Armitage P and Berry G: Statistical methods in medical research. 4th ed. London: Blackwell Publishers, 2001. Good
explanations of statistics commonly used in medical research.
Bailar JC, Hoaglin D. Medical uses of statistics, 3rd ed. Wiley 2009. Easy to read description of statistical concepts,
study design, statistical writing.
Berry DA. Statistics: A Bayesian perspective. Wadsworth Publishing 1995. Very easy to read, lots of examples.
Essex-Sorlie D. Medical biostatistics and epidemiology. Appleton & Lange, 1995. Very brief but complete to-the-point
discussion of common statistical tests, doesn't deal with more complex analyses.
Glantz SA. Primer of biostatistics, 7th ed. McGraw-Hill, 2011. Very easy to read, good examples from the medical
literature.
Inglefinger JA, Ware JH, Thibideau LA. Biostatistics in clinical medicine 3rd ed. McGraw-Hill, 1993. Tests presented as
solutions to clinical problems, good explanations, many illustrations from the medical literature.
Katz MH. Multivariable analysis: a practical guide for clinicians and public health researchers, 3rd ed. Cambridge
University Press, 2011. Very easy to read and understand discussion of more complex analyses.
Khan Academy online course: http://www.khanacademy.org/math/probability. The Kahn Academy offers a collection of
short (5-10 min) videos by Sal Kahn on important concepts in statistics).
Motulsky H. Intuitive biostatistics: a nonmathematical guide to statistical thinking, 3rd ed. Oxford University Press 2014.
Concepts of analysis and interpretation are explained with real-world examples that are intuitively apparent.
Norman GR and Streiner DL. Biostatistics: The bare essentials. 3rd ed. BC Decker Inc, 2008. Very easy to read, limited
math, excellent coverage of essential information, lots of examples, main limitation is frat-boy humor.
Rosner B. Fundamentals of biostatistics, 7th . Brooks/Cole, 2011. Traditional approach to biostatistics but more readable
than other texts, strong on examples from medical research.
StatSoft on-line textbook: http://www.statsoft.com/textbook. Reasonable reference for those needing a fast easy-to-use
statistical resource.
Zar JH. Biostatistical Analysis 5th ed. Prentice Hall, 2009. Traditional approach to biostatistics, heavy reading.
Suggested Other Reading (Stata):
Acock AC. A Gentle Introduction to Stata, 4th ed. Stata Press, 2014 (ISBN: 978-1597181426) Best overview for material
covered in introductory class.
Rabe-Hesketh S and Everitt B. A Handbook of Statistical Analyses Using Stata, 4 th Ed, Chapman & Hall/CRC 2007
(ISBN: 978-1-58488-756-0) Also covers some advanced topics, good for the more serious user.