Introduction to Clinical Trials 



 
 November 22, 2009

 
Course Syllabus

Course Description | Course Objectives | Course Topics | Course Format | Grading Policy | Course Materials | Office Hours | Contact Information | Help | Ethical Conduct


 

Course Description

Introduces clinical trial design in the context of epidemiological concepts, covers various topics in the design and conduct of clinical trials, and profiles clinical trials that illustrate these issues. Topics include the definition and history of clinical trials; trial designs, including phase I-IV, cross-over, factorial, and large, simple designs; internal and external validity; controls, randomization, and masking; ethical issues; data analysis principles; monitoring of accumulating safety and efficacy data; and use of data from randomized trials.


Course Objectives

After completion of this course, you should be able to do the following:

  • Present the scientific rationale for conducting clinical trials
  • Describe various clinical trial designs 
  • Demonstrate an understanding of randomization and of the principle of analysis by assigned treatment
  • Discuss the ethical issues in clinical trials and the related U.S. regulations and guidelines for the conduct of trials
  • Illustrate topics with examples of clinical trials

Course Topics

This course covers the following topics:

  • History of clinical trials
  • Definition and features of trials
  • Randomization
  • Types of trial designs
  • Outcome selection/surrogates
  • Generalizability and representativeness
  • Drug development process
  • Federal regulation
  • Ethical issues
  • Data monitoring issues
  • Sample size for survival outcomes
  • Publication of trial results
  • Reporting trials/CONSORT guidelines
  • Using evidence from trials in decision making
  • Whether clinical trials are still the gold standard

Course Format

This is a three-unit course taught through the Johns Hopkins Bloomberg School of Public Health Distance Education Division. The content of the course is presented through seventeen lectures, and the concepts applied through five assignments over the eight-week period of the first term.

Lectures: Students are expected to listen to the lectures as scheduled. There will be the five assignments (described below).

Assignments: After each assignment is made available on the Web site, students should review the assignment instructions and begin work. The assignment should be discussed with other students on the course bulletin board. Participation in assignment bulletin board discussions is a course requirement. 

Final Exam: This will be a closed-book exam consisting of short answer questions. The exam will be taken online, and you will not need a proctor.

Participation: Participation will be based upon your attendance and participation in LiveTalks.


Grading Policy

Grades will be based on the assignments, the final exam, and participation.

  • Assignments: 50% (10% for each exercise). Grades on late assignments will be reduced by .25 points per day.
  • Final exam: 40%. No exam retakes will be allowed. Conflicts with the exam date will be handled on a case-by-case basis, but students with nonemergency conflicts will be required to take the exam early. 
  • Participation:10% Based on your attendance and participation in LiveTalks

Please note the following:

  • All direct quotes must be attributed appropriately (see academic ethics code)
  • Re-grading of assignments or exam may results in an increase, decrease or no change to the grade
  • No late assignments will be accepted after close of the final exam, midnight Friday, March 20, 2009; assignments received after that date will receive a score of 0.
  

Course Materials

Required:

  • Textbook: Fundamentals of Clinical Trials.
    Lawrence M. Friedman, Curt D. Furberg, and David L. DeMets, Springer-Verlag, New York, 1998.

This text can be ordered through: 

Matthews Johns Hopkins Medical Book Center
1830 East Monument Street
Baltimore, MD 21205 USA
410.955.3931
800.266.5725
410.955.0576 Fax
http://www.cbamatthews.com/jhmedbook/

Other reading materials:

  • Additional course readings are available in the Online Library. 


Office Hours

Chat via TextChat
Ozlem Topaloglu Mondays, 5-6:00 p.m. EST
Lea Drye: Wednesdays, noon- 1:00 p.m. EST


Contact Information

Please send all queries for faculty regarding course registration to introct645@jhsph.edu

Course Faculty

Janet Holbrook, PhD, MPH
Email: introct645@jhsph.edu

Lea Drye, PhD
Email: introct645@jhsph.edu

Teaching Faculty

Ozlem Topaloglu
Email: introct645@jhsph.edu

Guest Lecturers

Kay Dickersin, PhD
Email: kdickers@jhsph.edu

Jay Herson, PhD
Email: jay.herson@earthlink.net

Barbara Martin, PhD
Email: introct645@jhsph.edu

 


Help

Concerns
Contact
Concerns about course topics and assignments
Technical concerns about the functionality and operation of course Web pages (before emailing, please make sure that you can replicate the problem)
  • DEHelp, the central help system for all tech support inquiries related to DED courses
Technical help on weekends
  • JHSPH User Support: 410-955-3781
Concerns about your Internet connection
  • Your Internet service provider (e.g., AT&T, Erols, etc.)
Concerns about your personal software
  • Your software vendor


Ethical Conduct

The academic ethics code, as discussed in the Policy and Procedure Memorandum for Students, March 31, 2002, will be adhered to in this class.


Disability Support Services

If you are a student with a documented disability who requires an academic accommodation, please contact Betty H. Addison in the Office of Career Services and Disability Support: dss@jhsph.edu, 410-955-3034, or Room E-1140.

 

© 2009 The Johns Hopkins University. All rights reserved.
Copyright to this collective work of materials is owned by The Johns Hopkins University.
Copyright to individual contributions may be retained by contributing authors.