Developed for University of Miami K12 Calabresi Scholars and modeled after the AACR-ASCO Methods in Clinical Cancer Research Workshop (Vail), this course includes 20 hours of lectures and discussion over five weeks. Participants complete homework assignments leading to the development of a clinical trial protocol ready for IRB submission by the end of the workshop series. Lectures teach basic research concepts and principles that underlie the design and actual day-to-day conduct of clinical trials, using examples primarily from cancer trials. The course is open to Sylvester junior faculty, fellows, and residents in addition to the K12 Scholars.
Week 1 – Overall Study Design
Phase 1 Trials Including Combination Studies
Phase 2 Clinical Trials Considerations in Special Trial Design
Week 2 – Statistical Aspects of Clinical Trials
Phase 1 Studies: Early-Phase Trials with Dose Escalation and Dose Expansion
Phase 1 Dose Escalation Trials: Model-Based Dose Escalation Designs
Statistical Aspects of Correlative Studies
Week 3 – The Role of the Principal Investigator
You’re in Charge: Responsibilities of an Investigator
Data Management Strategies to Ensure Analyzability and Integrity
Responsibilities of a Sponsor Investigator of an FDA IND-Holding Trial
Week 4 – Career Paths and Ethical Considerations in Clinical Trials
Career Path of a Clinician-Investigator
Asking Important Questions
Clinical Trial Ethics and Informed Consent
Week 5 – Design and Analysis of Population Science Studies
Considerations in Population Science Study Design
Statistics in Population Science Studies
Ethical Considerations in Studies in Special Populations – Minorities, the Elderly, etc.
Watch the Course Online
Videos, presentations, and other relevant material from the 2019 course will be made available through the University of Miami’s Blackboard system. You will need a Cane ID to access the site.