STATISTICS IN CLINICAL AND TRANSLATIONAL RESEARCH ...

STATISTICS IN CLINICAL AND TRANSLATIONAL RESEARCH CTSC 5103S (3 credits) Wednesday evenings, 4:30-7:30pm RWJMS Clinical Academic Building, Room 3405, New Brunswick, NJ Course Directors: Yen-Hong Kuo, Ph.D., & Ramsey Foty, Ph.D. Date 09/07/11

Week Topic 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

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09/21/11

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Introduce Project: Statistical Analysis Plan and Report of a Clinical Trial Probability and Probability Distributions a. Probability b. Conditional probability c. Statistical methods in diagnostic medicine and screening test d. Binomial distribution e. Normal distribution Estimation a. Sampling distribution b. Confidence interval 1) Population means 2) Population proportions c. Sample size estimation based on accuracy of estimation

Readings Ch. 1, 2

Ch. 3, 4

Ch. 5, 6

Homework Assignment Due: Summary Statistics

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

Version: 08/18/11


10/05/11

10/12/11

10/19/11

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Week Topic 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 5 Analysis of Variance a. Comparisons between and among means b. Multiple comparisons

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Homework Assignment Due: Confidence interval and hypothesis testing Analysis of Categorical Data a. Chi-square test b. Relative risk and Odds ratio c. Sample size estimation based on proportions Homework Assignment Due: Sample size estimation based on sample means 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


Readings Ch. 7

Ch. 8

Ch. 12 Ch. 14

Handouts

Version: 08/18/11


Week Topic 8 Correlation and Regression a. Correlation b. Simple linear regression

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11/09/11

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11/16/11

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Project Part I Due: Statistical Analysis Plan Multiple Linear Regression and Logistic Regression a. Multiple linear regression b. Model building and diagnosis c. Logistic regression Nonparametric Statistics a. Sign test b. Wilcoxon sign rank test c. Wilcoxon rank sum test d. Kruskal Wallis test Survival Analysis a. Kaplan-Meier procedure b. Log-rank test c. Cox proportional hazard model Homework Assignment Due: Regression Analysis and Nonparametric Analysis Biostatistics in the Genomic Age a. Microarray data analysis

Readings Ch. 9

Ch. 10, 11

Ch. 13

Ch. 12

Handouts

Review Assigned Readings

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Week Topic 13 Pharmacoepidemiology and Meta-Analysis a. Drug utilization b. Drug safety c. Drug effectiveness

Readings Handouts

Biostatistics in the Genomic Age a. Microarray data analysis

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Project Part II Due: Statistical Analysis Report Reading the Medical Literature a. Use of statistical analysis in medical literature b. Misuse of statistical analysis in medical literature Project Presentation a. Power Point presentation of Projects

Handouts

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-ProbabilityStatistics/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

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STATISTICS IN CLINICAL AND TRANSLATIONAL RESEARCH CTSC 5103S (3 credits) Wednesday evenings, 4:30-7:30pm RWJMS Clinical Academic Building, Room 3405, New Brunswick, NJ Course Directors: Yen-Hong Kuo, Ph.D., & Ramsey Foty, Ph.D. 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, 6th Edition - Bernard Rosner (2005) Duxbury Press - ISBN-10: 0534418201; ISBN-13: 978-0534418205

Assignments for Evaluation: 1) Homework Assignments (n=4) (30%) a. Questions based on specific lecture topics i. Use R to perform analysis ii. 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%) Contract Information Yen-Hong Kuo, Ph.D. Jersey Shore University Medical Center Email: [email protected] (Please use "CTSC 5103S" at the beginning of Subject line) TEL : 732-776-2906

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Version: 08/18/11