CLTR904: Approaches for Assessing Safety, Quality, and Benefit

Course Director:
Valeriy Korostyshevskiy, PhD
Assistant Professor, Biostatistics and Bioinformatics
Georgetown University Medical Center

Course Description: This course will examine the development and application of new or existing methods along the development pipeline to assess quality and safety of medical products for use in humans. The course will explore the various methods to ensure safety and quality for research participants, patients in treatment, and the public health. Modern tools and methods can analyze clinical data and inform regulators about the safety of medical products and ensure the quality of emerging technologies (i.e., nanotechnologies).

Students will learn terminology, approaches, and current practices by which regulators assess quality and safety as well as how novel approaches are incorporated into the regulatory review process to account for latest advances in science. Concepts are introduced and explored in a step-wise fashion through the use of case studies. A series of short essay exams will be administered throughout the semester to gauge student learning and comprehension of the basic assessment approaches before continuing to more advanced concepts.

Prerequisite: Introduction to Biostatistics in Clinical Research or an equivalent.

Learning Objectives:

  • Understand the drug development process and related statistical issues
  • Distinguish among different types of studies
  • Develop the ability to critically assess a protocol, a report, a scientific paper, etc., outlining the analysis
  • Understand how regulations and guidance are influenced by proper (and not so proper) statistical analyses in various environments