Course: Biostatistics for Medical Product Regulation

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Syllabus

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Course Description

Provides a broad understanding of the application of biostatistics in a regulatory context. Reviews the relevant regulations and guidance documents. Includes topics such as basic study design, target population, comparison groups, and endpoints. Addresses analysis issues with emphasis on the regulatory aspects, including issues of missing data and informative censoring. Discusses safety monitoring, interim analysis and early termination of trials with a focus on regulatory implications.

Course Objectives

Understanding the relevance and application of statistics and of statistical thinking to the regulatory process; an understanding of the basic principles of clinical studies and clinical trials, and their importance to the regulatory evaluation of new drugs, biologics and devices; and an awareness of sources of regulatory guidance, requirements, and evaluation information.

Prerequisites

Intended audience is graduate students in clinical medicine and public health interested in regulatory applications, or medical product development professionals, e.g., the biologics, medical device or pharmaceutical industry.

Prerequisite courses in basic biostatistics or epidemiology such as:

  • Principles of Epidemiology
  • Statistical Reasoning I or II
  • Fundamentals of Epidemiology

Readings

See Readings page for full list.

Course Requirements

Quizzes: 15%
Exam: 75%
Participation/Discussion: 10%

Grading Restrictions: Pass/Fail