Continuing Medical and Nursing Education Credits

Target Audience

This educational activity is intended for physicians in all oncology specialties, including hematology, medical oncology, surgical oncology, radiation oncology, gynecologic oncology, urologic oncology, and pediatric oncology, as well as basic and population science researchers, pharmacists, physician assistants, advanced registered nurse practitioners, nurses, research members, residents, fellows, postdoctoral scholars, and medical and graduate students.

Credit Designation and Accreditation

The University of Miami Leonard M. Miller School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. This live activity is designated for a maximum of 18 AMA PRA Category 1 Credits™.

The University of Miami School of Nursing and Health Studies is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation. This live Continuing Nursing Education activity has been approved to award a maximum of 18 contact hours.

Credit will be submitted on your behalf at the end of the six-week course.

Learning Objectives

At the conclusion of this activity, participants will be able to:

• Explain key characteristics of and differences among the three phases of drug development.
• Explain the concepts and rationale for phase I, II, and III studies and describe aspects of design and methodology used in each type of study.
• Describe the role of biomarkers in clinical research and apply strategies that incorporate biomarkers into study design.
• Assess the potential of high-throughput -omics assays and explain the basics of Next-Gen Sequencing.
• Appraise the value of correlative studies in clinical research.
• Illustrate how collaborations can lead to the most impactful science, clinical translational studies, and new clinical management paradigms.
• Distinguish between clinical practice and clinical research, including how ethical principles differ.
• Summarize federal regulatory requirements regarding clinical trials and the responsibilities of an investigator.
• Identify common FDA application types for drugs, devices, and biologics.

• Describe the types of committees involved in the protocol approval process and discuss aspects of protocol budgeting, contracting, etc.
• Differentiate the roles of different members of the clinical research team.
• Interpret the key components of a study protocol.
• Compare the potential career paths of clinical trialists and identify sources of support best suited to their research interests and career stage.

• Describe key factors in determining patentability of an innovation and whether patenting is the only path to commercialization.
• Identify factors that contribute to cancer health disparities in the U.S. and globally.
• Explain the pillars of valid consent and describe some of the origins of current research ethics standards.
• Assess the roles and value of incorporating PROs into clinical research and clinical practice.
• Evaluate how the increasingly competitive landscape of drug development impacts clinical trial design and endpoints.

Discloure and Conflict of Interest Resolution

All conflicts of interest of any individual(s) in a position to control the content of this activity will be identified and resolved prior to this educational activity being provided. Disclosure about provider and faculty relationships, or the lack thereof, will be provided to learners.