STAT 509: Design and Analysis of Clinical Trials

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course overview

This is a graduate level survey course that stresses the concepts of statistical design and analysis in biomedical research, with special emphasis on clinical trials. SAS for Windows statistical software will be used throughout the course for data analysis.

course topics

There are 19 lessons in this graduate level course that cover the following topics:

  • Ethical Considerations
  • Clinical Trial Designs
  • Bias and Random Error
  • Objectives and Endpoints
  • Sample Size and Power
  • The Study Cohort
  • Treatment Allocation and Randomization
  • Interim Analyses and Stopping Rules
  • Missing Data and Intent-to-Treat
  • Estimating Clinical Events
  • Prognostic Factors and Regression Models
  • Reporting and Publishing
  • Factorial Designs
  • Cross-Over Designs
  • Overviews and Meta-Analysis
  • Diagnostic Testing
  • Measures of Agreement

Here is a link to the Online Notes for STAT 509.

prerequisites

STAT 500, or STAT 501, or HES 520, or an equivalent introductory statistics course.

textbook

The required textbook for this course is:

Friedman, Lawrence M. (2010). Fundamentals of Clinical Trials. 5th Edition, Springer. ISBN: 9783319185385

software

In order to take this course, you need:

  • access to a Windows PC that has internet access, SAS, and Microsoft Word

assessment plan

  • 7 Check Your Understanding Quizzes – (33 points)
  • 4 Homework Assignments – (80 points)
  • 7 Discussion Activities – (37 points)
  • 1 Final Exam – (50 points)

academic integrity

All Penn State policies regarding ethics and honorable behavior apply to this course. Academic integrity is the pursuit of scholarly activity free from fraud and deception and is an educational objective of this institution. All University policies regarding academic integrity apply to this course. Academic dishonesty includes, but is not limited to, cheating, plagiarizing, fabricating of information or citations, facilitating acts of academic dishonesty by others, having unauthorized possession of examinations, submitting work of another person or work previously used without informing the instructor, or tampering with the academic work of other students.

For any material or ideas obtained from other sources, such as the text or things you see on the web, in the library, etc., a source reference must be given. Direct quotes from any source must be identified as such.

All exam answers must be your own, and you must not provide any assistance to other students during exams. Any instances of academic dishonesty WILL be pursued under the University and Eberly College of Science regulations concerning academic integrity. For more information on academic integrity, see Penn State's statement on plagiarism and academic dishonesty.

The Eberly College of Science Code of Mutual Respect and Cooperation embodies the values that we hope our faculty, staff, and students possess and will endorse to make The Eberly College of Science a place where every individual feels respected and valued, as well as challenged and rewarded.

disabilities

Penn State welcomes students with disabilities into the University's educational programs. If you have a disability-related need for reasonable academic adjustments in this course, contact the Office for Disability Services (ODS) at 814-863-1807 (V/TTY). For further information regarding ODS, please visit the Office for Disability Services Web site at http://equity.psu.edu/ods/.

In order to receive consideration for course accommodations, you must contact ODS and provide documentation (see the documentation guidelines at http://equity.psu.edu/ods/guidelines/documentation-guidelines). If the documentation supports the need for academic adjustments, ODS will provide a letter identifying appropriate academic adjustments. Please share this letter and discuss the adjustments with your instructor as early in the course as possible. You must contact ODS and request academic adjustment letters at the beginning of each semester.

course author

Rebecca Lengerich has been involved in teaching this course and brings extensive experience from her work as Senior Instructor, Health Evaluation Sciences at Penn State's College of Medicine. She has recently added a considerable amount of interaction to the course materials.