340.861.81 Clinical Trials: Procedures, Design, and Interpretation of Results
- 3rd term
- 3 credits
- Academic Year:
- 2018 - 2019
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:
- Describe and create essential components of a protocol and consent statement
- 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
- Explain standards for data management and analysis and apply knowledge in constructing case report forms
- Describe design, analysis and interpretation issues in non-inferiority and adaptive designs and choose an appropriate design to address a specific question
- Summarize standards for conducting systematic reviews and discuss how they can be used to synthesize evidence from clinical trials
- Describe the goal and methods for post-marketing surveillance of approved drugs.
- Explain purpose of data monitoring and describe some of the statistical methods used for data monitoring
- Methods of Assessment:
Protocol (including sample size and IND determination) 50%, consent form 20%, data collection form (5%) Participation in class and discussion forum 5%, LiveTalks assignments 20%
- 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.