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Clinical Trials: Procedures, Design, and Interpretation of Results

3rd term
3 credits
Academic Year:
2021 - 2022
Instruction Method:
Synchronous Online with Some Asynchronous Online
Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Course Instructor:
Janet Holbrook

Introduction to Online Learning is required prior to participating in any of the School's Internet-based courses. 340.645 Introduction to Clinical Trials


Augments Introduction to Clinical Trials (340.645). Describes current standards for clinical trial protocols, consent procedures and describes regulatory requirements and expands upon design and analysis concepts presented in 340.645. Reviews key standards for clinical trial protocols, including the SPIRIT guidelines, recruitment and consent of participants, and principles for data acquisition and sharing. Covers regulatory requirements for drug development and adverse event monitoring as well as the statistical aspects of data monitoring for clinical trials. Provides more in-depth discussion of newer designs for clinical trials including non-inferiority design and adaptive designs. Investigates specific analysis issues for handling missing data, interim monitoring and cost-effectiveness. Addresses the synthesis of results from clinical trials in meta-analyses and the role of post-marketing surveillance in assessing drug safety.

Learning Objectives:

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

  1. Describe and create essential components of a protocol and consent statement
  2. Explain US regulatory processes for development of new drugs including pertinent regulatory requirements for conduct of randomized clinical trials and consider whether a specific intervention will be subject to FDA regulations
  3. Explain standards for data management and analysis and apply knowledge in constructing case report forms
  4. Describe design, analysis and interpretation issues in non-inferiority and adaptive designs and choose an appropriate design to address a specific question
  5. Summarize standards for conducting systematic reviews and discuss how they can be used to synthesize evidence from clinical trials
  6. Describe the goal and methods for post-marketing surveillance of approved drugs.
  7. Explain purpose of data monitoring and describe some of the statistical methods used for data monitoring
Methods of Assessment:

This course is evaluated as follows:

  • 75% Final Project
  • 10% Assignments
  • 15% Participation

Instructor Consent:

No consent required

Special Comments:

Do not take this course if you have taken or plan to take: 340.633 Data Management in Clinical Trials; 340.648 Clinical Trials Management; or 140.642 Design of Clinical Experiments.