140.642.71
Design of Clinical Experiments

Cancelled

Prerequisite:

140.621-623 or 140.611-14. One of the two sequences must be completed prior to enrollment in this course. It is not sufficient to be enrolled in the 3rd term of the Biostatistics sequence at the same time as this 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.

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:

This course is evaluated as follows:

• 20% Discussion section
• 50% Homework
• 30% Final Project

Instructor Consent:

Consent required for some students

Consent Note:

Consent required for auditors

For consent, contact:

esugar2@jhu.edu