CLINICAL TRIALS: ISSUES AND CONTROVERSIES Syllabus

340.635.11 | AY 2013-2014 - Summer Inst. Term | 2 Credit(s)
MTWThF 8:30:00 AM
  • Contact Information
  • Course Learning Objectives
  • Course Description

    Covers the complex issues and controversies that surround the design, analysis and interpretation of clinical trials. Topics include selection of the study population (including issues related to enrollment of minorities and women); choice of "control" and "active" treatments including use of placebos; issues pertaining to informed consent; use of intermediate (or pre-clinical) outcomes versus clinical outcomes; adaptive designs; pragmatic vs. explanatory trials; comparative effectiveness research and the role of trials; and issues related to publication and dissemination. Uses examples of published, on-going and planned studies.

  • Intended Audience

    JHSPH students and SI participants

  • Methods of Assessment

    Grading Policy: 5 page paper

    Grading Restrictions: Letter grade

  • Prerequisites

    Basic epidemiology.

  • Academic Ethics Code

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

    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.

  • 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 Student Life Services: baddison@jhsph.edu, 410-955-3034, or 2017 E. Monument Street.