INTRODUCTION TO CLINICAL TRIALS Syllabus

340.645.01 | AY 2013-2014 - 2nd Term | 3 Credit(s)
MWF 1:30:00 PM
  • Contact Information
    Faculty
    Janet Holbrook
    Lea Drye
  • Course Learning Objectives

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

    • Present the scientific rationale for conducting clinical trials
    • Assess various clinical trial designs
    • Discuss randomization and the principle of analysis by assigned treatment
    • Discuss ethical issues in clinical trials and with related U.S. regulations and guidelines for the conduct of trials
    • Illustrate topics with examples of clinical trials
  • 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.
  • Intended Audience
    Students wanting to become acquainted with basic clinical trial methodology, either to broaden their knowledge of public health and clinical research, or to obtain a basis for more advanced study of the design and conduct of clinical trials
  • Methods of Assessment

    assignments and final exam

    Additional Faculty Notes:

    Exercises – 50% (10%, or 10 points, for each exercise)

    Final exam – 40%

    Participation –10%

    Grades on late assignments will be reduced by 0.25 points per day. No exam retakes will be allowed. Conflicts with the exam date will be handled on a case-by-case basis, but students with non-emergency conflicts would be required to take the exam early.

    Requests for re-grading will be considered.  Please note, that the second grade will be the final grade regardless of whether it is higher or lower than the first grade.

     

  • Prerequisites
    340.601 or 340.751

    Additional Faculty Notes:

    First term of the epi series (340.751) also is acceptable.

  • Required Text(s)

    Additional Faculty Notes:

    Required: Fundamentals of Clinical Trials Lawrence M. Friedman, Curt D. Furberg, and David L. DeMets, Springer-Verlag, New York, 2010. (Textbook available online from Welch Library)  Journal articles:  Journal articles will be posted on e-reserves.  Links to these articles are provided with each class session on this website.  Other reading and course materials: Students will be provided with a course packet of required readings other than those in the text or those available through e-reserves. Lecutre handouts: Lecture handouts will be provided at the beginning of each class. Links to lecture handouts, web and e-reserve materials, assignments, and a course bibliography may be found on this website.

  • Course Schedule

    Please see the course Session for a full list of dates and items for this course.

  • Academic Ethics Code

    Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.

  • Course topics

    History of clinical trials; Randomization; Types of designs; Outcome selection/surrogates; Drug development process; Masking treatment assignment; Ethical issues; Federal regulations; Generalizability and representativeness; Analysis by assigned treatment; Data monitoring; Sample size; Reporting trials/CONSORT guidelines; Failure to pulish: reasons and consequences; Using evidence from trials; Are clinical trials still the gold standard?

  • Contact Information(from old syllabus)

    Kay Dickersin, PhD
    Email: kdickers@jhsph.edu
    Tel: 410-502-4421

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

    Lea Drye, PhD, MS
    Email: introct645@jshph.edu
    Office: 911 S. Ann St
    Tel: 443-287-3170

    Nicole Cameron

    ncameron@jhsph.edu

  • Course Objectives(from old syllabus)
    - Acquaint students with the history of trials - Discuss use of evidence from randomized trials
  • Disability Support Services
    If you are a student with a documented disability who requires an academic accommodation, please contact the Office of Student Life Services at 410-955-3034 or via email at dss@jhsph.edu.