Despite the exponential rate of progress in understanding the cellular and molecular biology of cancer, clinical oncology care has not fully incorporated these mechanistic insights. This course is designed to provide physicians and others involved in developing and managing clinical trials with key information to advance a program of clinical research, to foster better clinical trial design and ultimately improve patient care.

Course Goals

• Discuss the full spectrum of challenges and opportunities in clinical cancer research.
• Facilitate collaborations and diverse networks among workshop participants.
• Provide guidance on the development of clinical trial protocols.
• Introduce principles of good trial design.
• Develop a cadre of well-trained, experienced clinical researchers who will become future leaders in clinically focused cancer research.

Developed for University of Miami K12 Calabresi Scholars and modeled after the AACR-ASCO Methods in Clinical Cancer Research Workshop (Vail), this course teaches basic research concepts and principles that underlie the design and actual day-to-day conduct of cancer clinical trials.

Topics and Structure

The six-week course, which takes place annually in the fall, offers up to 18 hours of CME credit for physicians and advanced practice nurses. University of Miami graduate students can enroll for master’s or PhD credit.

Topics include:

• Phase I, II, III, and non-interventional trial design and statistics
• Responsibilities of a PI
• Biomarkers, bioinformatics, and correlative studies
• Federal regulatory processes and funding mechanisms
• Ethical issues in clinical research
• Patient-reported outcomes in clinical trials
• Case studies highlighting issues related to diversity, recruitment and retention, accrual and financial feasibility, and the use of technology in clinical trials

Watch the Course Online

Recordings from the 2022, 2021, 2020, and 2019 courses are available on the Sylvester intranet with University of Miami login.

Course Contact 

Vaughn Edelson 
Senior Project Manager 
Phone: 305-243-1516
Email: vte3@miami.edu