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Course Catalog

140.642.01 DESIGN OF CLINICAL EXPERIMENTS

Department:
Biostatistics
Term:
1st term
Credits:
3 credits
Academic Year:
2012 - 2013
Location:
East Baltimore
Class Times:
  • Tu Th,  1:30 - 2:50pm
Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Contact:
Elizabeth Sugar
Course Instructors:

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Prerequisite:

140.621-23 or 140.611-14

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.

Learning Objectives:

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

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

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

Instructor Consent:

No consent required