340.655.01
Advanced Methods in Clinical Trials
Location
East Baltimore
Term
4th Term
Department
Epidemiology
Credit(s)
3
Academic Year
2023 - 2024
Instruction Method
In-person
Tu, Th, 1:30 - 2:50pm
Auditors Allowed
No
Available to Undergraduate
Yes
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
Every Year
Resources
Prerequisite
Introduction to Clinical Trials (340.645), Epi Mthds III (340.753 or 340.763), AND Stats Mthds in Public Health III 140.623 or Methods in Biostatistics 140.653.
Expands on the concepts presented in Introduction to Clinical Trials (340.645) and Clinical Trials: Procedures, Design, and Interpretation of Results (340.861) by elaborating on clinical trial analytical considerations and design options in both the regulatory, clinical, and public health context. Details design considerations, budgeting and recruitment strategies, communication of clinical trial results, and reporting responsibilities. Navigates the financial and administrative aspects of trial planning, creates a comprehensive recruitment strategy, applies necessary trial components and considerations for regulatory submissions, describes the roles and responsibilities of a data/clinical coordinating center, and communicates and interprets the results of a trial.
Learning Objectives
Upon successfully completing this course, students will be able to:
- Explore concepts for trial planning, conduct, design, analysis, and reporting in regulatory context
- Illustrate variety of commonly (i.e. group-sequential, adaptive) and less commonly (i.e. platform, single arm) used trial designs for clinical and community interventions
- Elaborate on considerations in clinical trial decision-making for the purposes of product development within the regulatory context versus clinical decision making
- Enumerate regulatory considerations in the design of clinical trials evaluating clinical product efficacy
Methods of Assessment
This course is evaluated as follows:
- 10% Participation
- 50% Written Assignment(s)
- 40% Group Project(s)