ETLS 724 Medical Device - Clinical Studies

Instructors:

Dr. Frank Freedman and Perry Parendo, PE

Time:

Section 13, Thursday, 6:00 – 9:00 p.m.

Location:

St. Paul Campus, OSS 127

Telephone/ e-mail:

Mr. Perry Parendo, PE: perry_par2002@yahoo.com

Optional Text:

Principles and Practice of Clinical Research (John I. Gallin, editor), Academic Press, ISBN 0-12-274065-3

Course Description:

This course teaches clinical study design, research hypotheses, statistical considerations, clinical study planning and executions. Students are trained to apply this information to plan and execute clinical studies that encompass a wide variety of clinical objectives: prototype evaluation, pivotal studies, FDA approval requirements, marketing claims, customer acceptance, reimbursement, etc.).  Other topics include data form design, report writing, databases, applicable U.S. and International Regulations and selected topics of interest.

Course Objectives:

The instructional materials and approach will be designed to provide:

• a fundamental understanding of medical device clinical studies,
• practical experience in developing a clinical study design and management plan and
• an opportunity to acquire specific experience for career or job decisions
• optional: an opportunity accomplish a personal objective relating to this course

Learning Outcomes:

Upon successfully completing this course, students should be able to:

- communicate effectively with clinical research professionals: MS2,* TM6*

- recognize clinical study career opportunities: MS1*

- understand how to design and manage a clinical research study: SE 10,* SE 15,* SE16*

- obtain employment or advance within the clinical research field: MS2,* MS4*

        *  Program Outcome Reference

Course Methodology:

The instructional approach will rely upon formal lectures, informal discussions, homework assignments, guest speakers and student projects.

Major
Assignments:

Prepare informed consent materials and develop basic study designs, characterize study subjects, study planning exercises and sample size estimates

Grading Policy:

Academic Integrity:

All students are expected to understand and follow the University of St.Thomas policies on Academic Integrity. These are described at:
www.stthomas.edu/engineering/graduate/policies/2006-07AcadIntegrity.html

Attendance
Policy:

Students are expected to attend all class sessions. Circumstances which prevent attendance will be honored up to two instances. Absences in excess of two times may result in an incomplete grade for the course. Contact the instructor when a special situation arises. All absences require that the instructor be informed in advance.

Instructor Background:

Perry Parendo, BSME and PE  Consultant and Adjunct Professor at the University of St. Thomas since 1996.  Expertise in product and process improvements through Design of Experimentation techniques and statistics.

ETLS 724

Medical Device Clinical Studies

Spring 2007

Class / Date

Topics

Assignments

First Class

Feb 1

Introduction

Presentation of Team Projects

Overview and Protocol Development

Phase I Study Protocol*

 *  designates individual    assignments

Second Class

Feb 8

Clinical Study Planning

Study Subjects*

Current Therapies*

Third Class

Feb 15

Clinical Study Management Planning – Part II

Ethical, Legal and Regulatory Perspectives of           Clinical Studies

Protection of Human Subjects Regulation

Phase I Study Results

Fourth Class

Feb 22

First Test

Consult with an Expert

IDE Regulation

Informed consent – part I*

Fifth Class

Mar 1

Study Objectives 

Establish Hypothesis(es)          

Subject and Investigator Selection

Study Designs: types of designs, no. subjects, randomization, controls, etc.

Sixth Class

Mar 8

Study Designs: Blinding, end points, outcomes, sensitivity/specificity, etc.                  

Seventh Class

Mar 15

Statistical Analysis/Plan 

Statistical Review

Informed consent – part II*

Vacation

Mar 22

No Class     Mid-Term Break

Eighth Class

Mar 29

Second Test

Institutional Review Boards

Student Team Projects – Progress Reports                            

TBD

Ninth Class

Apr 5

Guest Speaker or Tour

Executing The Study

Consult with the Experts

Tenth Class

Apr 12

Third Test

Study Compliance                     

Guest Speaker

Eleventh Class

Apr 19

Clinical Data

Miscellaneous Topics

Twelfth class

Apr 26

Fourth Test

Student Team Projects – Progress Reports 

Fourteenth Class

May 3 

Final Team Presentations

Finals Week

May 10

TBD