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:
Mentorship
All scholars have both a clinical mentor and a translational research mentor (in molecular translational or population science research). See the list of K12 mentors. At least one of these mentors must have external, peer-reviewed funding as defined by the NCI.
In addition, each scholar will, with their input, be matched with a peer mentor who has demonstrated early clinical research and academic success, and with a patient/community mentor, to facilitate incorporation of the lay/community perspective into trial design and recruitment.
In the first year of their K12 term, Scholars participate in the annual Research Mentoring Training Program with one of their mentors.
Individual Development Plan (IDP)
In consultation with their mentors and K12 leadership, each scholar customizes 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 must write at least one protocol for a clinical trial that tests hypotheses and preferably includes translational correlates. Scholars are 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 accrue and treat patients on the protocol, analyze the results, and prepare abstracts and manuscripts on the findings.
Beyond a single trial, scholars are 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 at least 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 K12 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 present their work each year at the Annual Calabresi Symposium, and in year two of the program, scholars 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 complete the online, asynchronous NIH course, Introduction to the Principles and Practice of Clinical Research, and 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 Course
- Clinical Trials Biostatistics Journal Club
- Invited PI Journal Club
- Site Disease Group Weekly/Monthly Clinical Trials Working Groups
- Study Start-Up Workshop
- Sylvester Molecular 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 resources may be applied in clinical trials, Scholars will participate in a series of presentations by core leaders highlighting their resources and technologies.
Protocol Review and Monitoring Observership
To gain greater familiarity with trials infrastructure and deeper understanding of the protocol lifecycle, scholars spend 2-3 months as shadow reviewers for the Protocol Review and Monitoring Committee (PRMC). They then follow selected protocols through activation, including review by the Institutional Review Board (IRB) and Clinical Research Internal Advisory Board (CRIAB), financial assessment by the Office of Research Administration (ORA), and eventually review by the Data and Safety Monitoring Committee (DSMC).
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.
Community Outreach and Engagement Training
To experience Sylvester’s efforts to engage community populations and understand how such interactions shape clinical trials and discoveries that are catchment area relevant, scholars are required to spend at least two days on the Sylvester Game Changer Vehicle. Scholars will also be introduced to SCAN360, a Sylvester-developed database that characterizes the factors that drive patterns in cancer burden in Sylvester’s unique catchment area and the state of Florida.
Introduction to Innovation and Commercialization
Scholars participate the Concept 2 Commercialization Seminar Series and other activities of the Wallace H. Coulter Center for Translational Research (WHCC), such as WHCC committee meetings, to observe how projects are selected for funding and business development support. Scholars also have the opportunity to speak with members of U Innovation, which leverages the combined resources of the Office of Technology Transfer, the WHCC, The Launch Pad (UM’s entrepreneurship platform), and the 'Cane Angel Network to support knowledge translation and commercialization of novel ideas, research discoveries, and innovations that improve the lives of our local, national, and international communities.
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.
Questions? Contact Vaughn Edelson at vte3@miami.edu.