ALS 433: Design of Clinical Trials
400-level Technical/Business Designations: Technical
Clinical and Regulatory Affairs: Required
Medical Devices and Diagnostics: Elective
Pharmaceutical Discovery and Development: Elective
This course will provide students with a more in-depth understanding of clinical trial design, conduct and strategy for therapeutic products. Clinical trial design elements will be examined in the context of their impact on clinical trial outcomes. Emphasis will be placed upon trial designs that reflect the biological nature and mechanism of action of the therapeutic product being tested, rather than a cookbook approach. Design elements related to small molecules, antibodies, therapeutic proteins, therapeutic vaccines, and cell and gene therapies will be discussed. Discussions will include operational issues impacting execution of clinical trials and why they are critical elements of successful clinical development programs. Students will gain an understanding of the principles for use of particular biostatical testing procedures and in what context certain methods should be used. There will be an emphasis on clinical development problem solving as students work on team projects and defend their own clinical development solutions in the context of product profiles, strategy and timelines.
Prerequisite of ALS 362 or permission of instructor (PPM; PPC)
- History of Clinical Trials
- Phase 1, 2, and 3 study design
- Phase 4 and post-marketing study design
- Clinical Trial elements including objectives, eligibility criteria, treatment regimen, adverse event assessment and reporting, dose modification, efficacy response, assessment, informed consent, data monitoring committees
- Operational issues including clinical site selection, interactions with Investigational Review Boards, data monitoring, clinical data management, case report forms
- Clinical trial study reports and analyses
- Basic biostatistics related to superiority, non-inferiority and equivalence study designs
- Clinical development program problem solving
- Clinical development strategy in a competitive landscape
After completing this course, students should be (1) conversant in clinical trial design elements including objectives, eligibility criteria, treatment regimen, adverse event assessment, dose modification, efficacy response assessment, informed consent, and data monitory committees, (2) knowledgeable in the critical operational issues that must be tracked for successful execution of clinical studies, (3) knowledgeable in the design principles for Phase 1, 2, 3 and 4 studies, (4) able to apply biostatical principles and know the appropriate settings in which to use particular biostatical test methods, (5) able to understand clinical trial analysis and reporting, (6) able to develop greater confidence in creating a clinical development strategy and (7) able to develop a compelling presentation to defend a particular clinical trial development strategy.
There will be 4 exams total; 3 section exams and a final exam. The final exam will be comprehensive. Exams will consist of true/false and multiple choice questions. Each section exam will be worth 15% of your course grade. The final exam will be worth 40% of your course grade. Exams will be administered via Sakai on the date listed in the class schedule. On exam dates, you do NOT need to report to class. Exams will be available for completion on the assigned date from 12:00noon until midnight. If for any reason you cannot complete the exam during the assigned time period, please contact Deborah Flynn immediately.
The remainder of your grade will be determined by class participation and attendance (15%).