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Clinical Research Resources

Scholars will benefit from a variety of learning opportunities to prepare them for their careers conducting patient-oriented, cancer clinical trials, from one-on-one meetings with mentors to classroom-based didactic coursework to conferences. The Calabresi Program comprises the following components: 

Mentoring Dyad

Each Scholar will have both a Clinical Mentor and a Translational Research Mentor (in Molecular Translational or Population Science Research). See the list of K12 Mentors.

Individual Development Plan (IDP)

In consultation with their Mentors and the K12 director, each Scholar will customize their own course of study to include Calabresi Program requirements and optional activities, as outlined here. 

Design and Execution of Hypothesis-Driven Clinical Trials

All Scholars will write at least one protocol for a clinical trial that tests hypotheses and preferably includes translational correlates. Scholars will be required to obtain institutional approval for scientific merit through Sylvester’s Protocol Review and Monitoring Committee (PRMC) and approval for ethical concerns through the Institutional Review Board. 

Scholars will accrue and treat patients on the protocol, analyze the results, and prepare abstracts and manuscripts on the findings.

Monthly Scholars Forum

Scholars and Mentors will come together monthly to share insights with each other and learn from distinguished clinical investigators from within and outside Sylvester regarding development of clinical and translational research to improve cancer care.

Annual Paul Calabresi Symposium

The first Symposium will take place in 2020. This annual, one-day event will bring together current and former Calabresi Scholars to share their experiences and learn from and network with clinical trial leaders. The day will feature a keynote speaker, as well as presentations and panels on research, mentorship, and career development.

Master of Science in Clinical and Translational Investigation (MSCTI)

The MSCTI, offered through the Miami Clinical and Translational Science Institute, provides a foundation for future practitioners and leaders of translational and clinical science to identify and overcome institutional, cultural, regulatory, and other barriers that inhibit translational research. MSCTI candidates complete 30 credits. 

The K12 curriculum includes many of the core and elective courses for the MSCTI, so it is strongly recommended that Scholars pursue the formal degree.

Instruction in Grant Writing and Scientific Presentation

Preparation of an R01, R21, or R01-equivalent application(s) is required of all Scholars. In year two of the program, Scholars will each give two seminars: one on their clinical work, and the other on translational research studies. Therefore, all Scholars will participate in the following activities to help develop their grant writing and scientific presentation skills:

Required Clinical Trials Courses, Workshops, and Seminars

To assist with the design and execution of clinical trials, Scholars will participate in the following required courses and workshops offered through the University of Miami and Sylvester. In addition, Scholars will attend at least one external workshop or conference on clinical trials over the course of their two-year term.

  • CITI Modules on Conflict of Interest, Good Clinical Practice, and Human Subjects Research
  • University of Miami Clinical Research Operations and Regulatory Support (CRORS) New Investigator Training 
  • Design and Management of Clinical Cancer Trials 5-Week Workshop Series
  • Research Ethics (CTI 603) 14-Week Course
  • Site Disease Group Weekly/Monthly Clinical Trials Working Groups
  • Biostatistics for Clinical Trials Journal Club 

Optional Courses, Workshops, and Seminars

Additional courses have been identified as potentially useful to be audited or taken for credit toward the MSCTI to give Scholars the tools they need to become independent, accomplished clinical investigators. Scholars have the option to pursue a “track” in population science or molecular translational research. 

To request a copy of the full K12 curriculum, contact Vaughn Edelson at vte3@miami.edu.