DESIGN OF CLINICAL EXPERIMENTS Syllabus

140.642.01 | AY 2013-2014 - 3rd Term | 3 Credit(s)
TTh 1:30:00 PM
  • Contact Information
    Faculty
    Elizabeth Sugar
    Jay Herson
  • Course Learning Objectives

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

    • Frame a scientific hypothesis that evaluates the question of interest and addresses issues of equipoise, feasibility, and the stage of development of the intervention.
    • Assess outcome variables for quantifying the scientific question of interest with an eye for bias, variability, duration, and availability
    • Discuss basic clinical trial design principles including bias control, random error control, randomization, blocking and masking
    • Describe specific types of designs of practical and historical interest including dose-finding, safety and efficacy, and comparative trials
    • Have a working knowledge of the quantitative properties of clinical trials including precision of estimation, power, and sample size
    • Discuss the importance of design and its relation to analysis of clinical trials
    • Describe the techniques for addressing analysis issues including missing data
  • Course Description

    Introduces the process for developing biomedical experiments from a statistical perspective. Stresses methods of controlling for bias and variability through outcome selection, design, sample size calculation, and analysis. Emphasizes clinical trials and other types of medical experiments likely to be encountered by biometric researchers. Discusses elements of analysis as related to the design principles.

     Time and Location:  Tuesday and Thursday 1:30-2:50pm, W4013

    Office Hours:

    • Elizabeth Sugar: By appointment (E3537)
    • Jay Herson: By Appointment
    • Thomas Prior: TBD
  • Intended Audience
    Students interested in learning more about the design of clinical experiments
  • Methods of Assessment

    Problem sets, participation in paper discussion sections, and a short project

    • Participation in discussion sections (20%)
    • Homework assignments (50%)
    • Final project (30%)
  • Prerequisites

    140.621-23 or 140.611-14

  • Required Text(s)

    Recommended textbooks:

    • Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB (2007).  Designing Clinical Research 3rd addition.   Lippincott Williams & Wilkins, Philadelphia, PA.
    • Piantadosi S (2005).  Clinical Trials: A Methodologic Perspective 2nd addition.  John Wiley & Sons, Inc, Hoboken, NJ.

     

    Websites of interest:

     

    Recommended reading:

    • ICH Harmonised Tripartite Guideline: Statistical Principles for Clinical Trials C9 (1998)
    • http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073137.pdf
  • 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 Format

    Each class section will be divided into two parts: a 50 minute lecture and a 30 minute discussion section.

  • Attendance Policy

    Since the discussion section accounts for roughly 30% of the lectures and 20% of the overall grade, attendence is important.  Attendence will be tracked with a sign-in sheet.

  • 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.