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Statistics in Clinical and Translational ResearchCTSC 5103S (3 credits)
Wednesday evenings, 4:30-7:30pm
RWJMS Clinical Academic Building, Room 3403, New Brunswick, NJ
Course Directors: Yen-Hong Kuo, ScM, MS & Ramsey Fort, Ph.D.

Date

Week

Topic

Readings

9/09/09
NOTE Room Change to CAB 3405

 

 

1

Overview and Descriptive Statistics

a.   Application of statistics in biomedical research
b.   Type of data
c.   Graphic representation of data
d.   Summary statistics: central tendency and dispersion
e.   Introduction to R

(Introduce Project: Statistical Analysis Plan and Report of a Clinical Trial)

To be assigned

9/16/09

2

Probability and Probability Distributions

a.   Probability
b.   Conditional probability
c.   Statistical methods in diagnostic medicine and screening test
c.   Binomial distribution
d.   Normal distribution

 

9/23/09

3

Estimation

a.   Sampling distribution
b.   Confidence interval
      1)   Population means
      2)Population proportions
c.   Sample size estimation based on accuracy of estimation

(Homework Assignment Due: Summary Statistics)

 

9/30/09

4

Hypothesis Testing

a.   Type I error, Type II error
b.   Steps of performing hypothesis testing
      1)   Hypothesis testing on population means
      2)   Hypothesis testing on population proportions
c.   Power and sample size estimation

 

10/07/09

 

5

Analysis of Variance

a.   Comparisons between and among means
b.   Multiple comparisons

(Homework Assignment Due: Confidence interval and hypothesis testing)

 

10/14/09

6

Analysis of Categorical Data

a.   Chi-square test
b.   Relative risk and Odds ratio
c.   Sample size estimation based on proportions

(Homework Due: Sample size estimation based on sample means)

 

10/21/09

7

Statistical Analysis Plan in Clinical Trials

a.   Study design in drug development
b.   Statistical considerations
      1)   Sample size determination
      2)   Endpoint definitions
      3)   Analyses (safety, efficacy)
      4)   Interim analyses

 

10/28/09

8

Correlation and Regression

a.   Correlation
b.   Simple linear regression

(Project Part I Due: Statistical Analysis Plan)

 

11/04/09
Note Room Change to CAB 3405

9

Multiple Linear Regression and Logistic Regression

a.   Multiple linear regression
b.   Model building and diagnosis
c.   Logistic regression

 

11/11/09

 

10

Nonparametric Statistics

a.   Sign test
b.   Wilcoxon sign rank test
c.   Wilcoxon rank sum test
d.   Kruskal Wallis test

 

11/18/09

11

Survival Analysis

a.   Kaplan-Meier procedure
b.   Log-rank test
c.   Cox proportional hazard model

(Homework Assignment: Regression Analysis and Nonparametric Analysis)

 

11/25/09

12

Biostatistics in the Genomic Age

a.   Microarray data analysis

 

12/02/09
Note Room Change to CAB 3405

13

Pharmacoepidemiology and Meta-Analysis

a.   Drug utilization
b.   Drug safety
c.   Drug effectiveness

(Project Part II Due: Statistical Analysis Report)

 

12/09/09

 

14

Reading the Medical Literature

a.   Use of statistical analysis in medical literature
b.   Misuse of statistical analysis in medical literature

 

12/16/09

15

Project Presentation

a.   Power Point presentation of Projects

 

Required Textbooks:
Biostatistics: A Foundation for Analysis in the Health Sciences, 9th Edition (2008) by Wayne W. Daniel

  • ISBN-10: 0470105828, ISBN-13: 978-0470105825.
  • Available on Amazon at : http://www.amazon.com/Biostatistics-Foundation-Analysis-Probability-Statistics/dp/0470105828/ref=sr_11_1?ie=UTF8&qid=1236359447&sr=11-1

Required Software:
R: A Language and Environment for Statistical Computing

  • FREE
  • Available from http://www.r-project.org

References and Recommended Books
Intuitive Biostatistics

  • Harvey Motulsky (1995) Oxford University Press
  • ISBN-10: 0-19-508607-4; ISBN-13: 978-0195086072

Principles of Biostatistics, 2nd Edition

  • M. Pagano & K. Gauvreau (2000) Duxbury Press
  • ISBN-10: 0534229026; ISBN-13: 978-0534229023

Fundamentals of Biostatistics, 5th Edition

  • Bernard Rosner (2000) Duxbury Press
  • ISBN-10: 0534370683; ISBN-13: 978-0534370688

Assignments for Evaluation:

1)   Homework Assignments (n=4) (30%)

       a.   Questions based on specific lecture topics
              i.   Use R to perform analysis
              i.i.   Interpretation of results

2)   Projects

      a.   Part I: Statistical Analysis Plan (20%)
      b.   Part II: Statistical Analysis Report (20%)
      c.   Final Power Point Presentation (30%)

This course has been approved by GSBS@RWJMS 03/18/09