Integration of clinical trial development in hematology and oncology fellowship training: Washington University School of Medicine experience.

person Christine Auberle Washington University School of Medicine in St. Louis, St. Louis, MO info_outline Christine Auberle, Feng Gao, Ningying Wu, Stuart Kornfeld, Joel Picus, Douglas Adkins, Morey Blinder, John Sutton Welch, Sana Saif Ur Rehman, Keith Stockerl-Goldstein, Neha Mehta-Shah, Elaine M. Majerus, Stephen Oh, Peter Westervelt, Ramaswamy Govindan, Daniel C Link, John F. DiPersio, Saiama Naheed Waqar, Lee Ratner

Authors person Christine Auberle Washington University School of Medicine in St. Louis, St. Louis, MO info_outline Christine Auberle, Feng Gao, Ningying Wu, Stuart Kornfeld, Joel Picus, Douglas Adkins, Morey Blinder, John Sutton Welch, Sana Saif Ur Rehman, Keith Stockerl-Goldstein, Neha Mehta-Shah, Elaine M. Majerus, Stephen Oh, Peter Westervelt, Ramaswamy Govindan, Daniel C Link, John F. DiPersio, Saiama Naheed Waqar, Lee Ratner Organizations Washington University School of Medicine in St. Louis, St. Louis, MO, Washington University School of Medicine, St. Louis, MO, Washington University in St. Louis, St. Louis, MO, Washington University, St. Louis, MO, A2 Biotherapeutics, Inc., Agoura Hills, CA, Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO Abstract Disclosures Research Funding Institutional Funding Washington University in St. Louis Background: Education in clinical trial design and development is highly variable among Hematology and Medical oncology fellowship programs. The Clinical Trial Development (CTD) program at Washington University in St. Louis (WUSM) is an experiential learning curriculum designed to provide a structured and personalized education to fellows about clinical investigation in Hematology and Oncology. We describe the results of the CTD program and its impact on subsequent academic faculty appointments. Methods: The CTD program was initiated at WUSM in 2002 as a hands-on learning experience for Hematology and Oncology fellows in the design, implementation, evaluation, and publication of clinical trials. Each fellow was required to identify a mentor in their first year of training and propose at least one CTD project, determined as a prospective investigator-initiated clinical trial involving human subjects or materials. Outcome data were collected from an internal registry of fellow CTD projects, Clinical Trials Management System (OnCore), PubMed, ClinicalTrials.gov and e-mail inquiries to fellows and mentors. Descriptive statistics were collected for the characteristics of CTD projects, including the phase of study, site (single center or multicenter), disease subtype, projects that received IRB approval, and projects that resulted in publication. Logistic regression and odds ratios (OR) were also used to assess the association between these characteristics and academic faculty appointments. Results: We included 118 fellows who began fellowship from 2002 to 2021 for this analysis with 16 still in training. Many trials were phase I/II (n = 53; 45%), phase I (n = 34; 29%) and phase II trials (n = 17; 14%) and most trials were single center studies (n = 93; 79%). Disease types of the investigations were evenly distributed between Oncology (n = 60, 51%) or Hematology (n = 58, 49%). Most fellows were successful in obtaining IRB approval for their CTD project (n = 93, 79%) and approximately two thirds of those with IRB approval went on to publish their results in peer-reviewed journals (n = 60, 65%). Forty-five percent of fellows who published their CTD projects were first authors (n = 27) and 38% published in journals with an impact factor of greater than 10. Among the graduating fellows, two-thirds (n = 67, 66%) secured an academic faculty appointment. Fellows with IRB approved CTD projects had significantly higher odds of obtaining an academic faculty appointment (OR 4.96, 95% CI 1.54-15.98, p < 0.05). Conclusions: The CTD program is a well-established clinical investigation program for fellows with a track record of success and impact on subsequent academic faculty appointments. The CTD program is a model that other fellowship programs can emulate for education related to clinical trials.