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Course Catalog

140.642.01 DESIGN OF CLINICAL EXPERIMENTS

Department: Biostatistics
Term: 3rd term
Credits: 3 credits
Contact: Elizabeth Sugar
Academic Year: 2013 - 2014
Course Instructors:
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 Objective(s):
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

Methods of Assessment: Problem sets, participation in paper discussion sections, and a short project
Location: East Baltimore
Class Times:
  • Tuesday 1:30 - 2:50
  • Thursday 1:30 - 2:50
Enrollment Minimum: 10
Enrollment Maximum: 40
Instructor Consent: No consent required
Prerequisite:

140.621-23 or 140.611-14

Auditors Allowed: Yes, with instructor consent
Grading Restriction: Letter Grade or Pass/Fail