Clinical Trial Concept in the Oncology Landscape

Ohio State University, Columbus OH

Investigators

Abstract

Project Summary The Clinical Trial Concept in the Oncology Landscape (CTC) is a virtual and in-person, hybrid course designed to educate oncology trainees and junior faculty from any cancer specialty in applying Good Clinical Practice (GCP) and scientific reasoning into effective clinical trial design. The course will accept junior oncologists and fellows/residents in an oncology specialty, who are novice in cancer clinical research. The course will deliver in Part 1, The Fundamentals of Clinical Research, a semester long virtual immersive educational experience across all areas of cancer clinical research, then culminate in an in-person Trial Concept Writing Camp (Part 2) during the annual American Association of Cancer Institute (AACI) Clinical Research Innovation (CRI) meeting where participants will be mentored by experienced clinical investigators from different AACI member institutions during which time, they will finalize a clinical trial concept (also called letter of intent (LOI)), the end product of this course. Participants are selected through a competitive application process consisting of a CV, personal statement, letter of support from a local clinical research mentor, and a career development plan. Accepted participants will first receive scientific and GCP training over 20 virtual sessions covering the 6 major modules of protocol development that encompass the eleven domains of clinical trial expertise, including oncology, science, medicine, business/negotiation, accounting, statistics, pharmacy, pharmacology, laws and regulations, ethics, and clinical trial management. The curriculum will be loaded on a web portal developed for educational purposes under another U24 NCI award to OSUCCC. The virtual training will use a flipped classroom approach to maintain participant attentiveness. At the CRI meeting, participants will interact with Faculty mentors, nationwide experts in clinical research, who will help them complete a realistic concept form that meets scientific standards. Participants will take part in pre- and post-tests to determine the cogency of the CTC curriculum for their professional practice, and the effectiveness of the course logistics. They will complete the course by submitting a finalized clinical trial concept to the CTC course directors. Afterwards, they should be able to use their concept to develop a full protocol at their own institutions or though the NCI clinical research networks or other clinical trial networks. After the course, public data will be used to track participants’ career trajectories to determine the long-term effects of the course on their careers, working with Academics Analytics, a company contracted with OSU. Impact. Investigators must apply GCP and the International Conference on Harmonisation (ICH) guidelines to the design and scientific approach of their clinical research. The basics of clinical research are not taught in medical schools or residencies. The pool of clinical investigators has also decreased in the US, creating a serious shortage of clinical trial experts. At the same time, there has been an explosion of biological discoveries and technological advances. This innovative and necessary CTC course will address the need for thorough and specific training on clinical trial design and execution to eventually benefit patients with cancers and support the professional development of junior oncology faculty.