Scholars benefit from a variety of learning opportunities to prepare them for careers conducting patient-oriented, cancer clinical trials, from one-on-one meetings with mentors to classroom-based didactic coursework to conferences. The K12 Calabresi Program comprises the following components:
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 K12 leadership, each Scholar will customize their own course of study to include K12 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.
Beyond a single trial, Scholars will be expected and supported to develop a long-term program of research, with translational work as the foundation of the research focus.
Monthly Scholars Forum
Scholars and K12 leadership 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
This annual event brings together current and former Calabresi Scholars to share their experiences and learn from and network with clinical trial leaders. The day features a keynote speaker, as well as presentations and panels on research, mentorship, and career development.
Grant Writing and Scientific Presentation
The ability to communicate research results in both written and oral formats is an essential career skill in academic medicine, so all Scholars participate in a variety of activities to help develop their grant writing and scientific presentation skills. Preparation of an individual K award, R21, R01, or equivalent application(s) is required of all Scholars. Before submission, Scholars participate in the Sylvester Faculty Development Program Specific Aims review process.
Scholars will present their work each year at the Annual Calabresi Symposium, and in year two of the program, Scholars will present individually as part of the Sylvester Junior Faculty Lecture Series. Finally, Scholars will receive instruction from a presentation skills coach.
Required Clinical Trials Courses, Workshops, and Seminars
To assist with the design and execution of clinical trials, Scholars participate in the following required courses and workshops offered through the University of Miami and Sylvester. In addition, Scholars attend at least one external workshop or conference on clinical trials over the course of their two-year term.
- Design and Management of Clinical Cancer Trials 5-Week Workshop Series
- Clinical Trials Biostatistics Journal Club
- Site Disease Group Weekly/Monthly Clinical Trials Working Groups
- Study Start-Up Workshop
- Sylvester Precision Medicine Tumor Board
Instruction in the Responsible Conduct of Research
- 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
- University of Miami Office of Research Compliance and Quality Assurance (RCQA) Courses, “Protocol Compliance from Start to Finish” and “Coercion and Undue Influence in Research”
Introduction to Sylvester Shared Resources
To further understanding of how Sylvester shared resourcesmay be applied in clinical trials, Scholars will participate in a series of presentations by core leaders highlighting their resources and technologies.
To gain greater familiarity with trials infrastructure, Scholars are required to observe at least one meeting of each of the following committees that review cancer-related trials: Protocol Review and Monitoring Committee (PRMC), Data and Safety Monitoring Committee (DSMC), Institutional Review Board (IRB) Cancer Protocols.
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.
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.
Download the full K12 curriculum
Questions? Contact Vaughn Edelson at firstname.lastname@example.org.