Over the past 10 years, the Academic Thoracic Oncology Medical Investigator Consortium (ATOMIC) has been at the forefront of conducting clinical trials in Thoracic Cancer using translational research methodologies. Over that time, we’ve gleaned some important facts about how trials come to fruition, and some of the obstacles to be overcome. This research paper provides insights into the IIT process, and how pharmaceutical sponsors approve and support these trials.
Published in Clin Cancer Res. 2025 Jan 17.
doi: 10.1158/1078-0432.CCR-24-3460.
https://pubmed.ncbi.nlm.nih.gov/39820484/
Development, review, and activation of thoracic oncology investigator-initiated trials
David E Gerber 1 , Claire R Wynters 2 , Tanushree Prasad 3 , Ronny K Schnel 4 , Song Zhang 5 , Thomas E Stinchcombe 6 , Liza C Villaruz 7 , Joshua M Bauml 8 , Wade T Iams 9 , Tejas Patil 10 , Stephen V Liu 11 , Leora Horn 12 , John M Hudak 4 , D Ross Camidge 13
Affiliations
- PMID: 39820484
- DOI: 10.1158/1078-0432.CCR-24-3460
Abstract
Background: Investigator-initiated trials (IITs) may address important biological and clinical questions that may not be prioritized by pharmaceutical sponsors. However, little is known about the process by which IIT proposals are evaluated and activated.
Methods: We performed a retrospective study of IIT concepts submitted through the Academic Thoracic Oncology Medical Investigators Consortium (ATOMIC), which comprises 13 institutions in the U.S. and Canada, from 2014 (consortium inception) to 2024. We compared approved and disapproved concepts using chi-squared tests, Fisher’s exact tests, and Wilcoxon Rank-Sum tests.
Results: Among a total of 68 presented IIT concepts, 60 (88%) received consortium approval a median of 30 days (interquartile range [IQR] 31-59 days) after submission. Concepts submitted by junior faculty were more likely to be approved than those from full professors (P=0.003). Of the 60 concepts subsequently submitted to pharmaceutical sponsors, 15 (25%) were approved, 43 (72%) were disapproved, and 2 (3%) remain under review. The median time between concept submission to a sponsor and the sponsor’s decision was 61 days (IQR 31-183 days). Concepts with shorter projected durations were more likely to be approved by the pharmaceutical sponsor (P=0.05). For sponsor-approved IIT concepts, median overall time from initial submission to trial activation was 18 months.
Conclusions: Only a small proportion of proposed investigator-initiated cancer clinical trials are successfully activated following a prolonged development process. Given the importance of IITs in addressing real-world, practical questions and the growing professional challenges facing clinical research physician faculty, further attention to IIT development facilitators and barriers is warranted.
About David Gerber, M.D.
David Gerber, M.D., is a Professor in the Department of Internal Medicine at UT Southwestern Medical Center, and a member of the Division of Hematology and Oncology. He serves as Co-Director of the Experimental Therapeutics Program.Originally from Chicago, Dr. Gerber holds a bachelor’s degree in history from Yale University in New Haven, Connecticut, where he graduated cum laude. He earned his medical degree at Cornell University Medical College in New York and completed his internship and residency in internal medicine at UT Southwestern, where he served as Chief Resident. He then received advanced training through a fellowship in medical oncology at Johns Hopkins University School of Medicine in Baltimore.
Certified by the American Board of Internal Medicine in medical oncology, Dr. Gerber joined the UT Southwestern faculty in 2007. He is invested in helping patients have a better quality of life. Dr. Gerber is active in research related to lung cancer, including clinical trials. His research has generated more than 250 publications that he has authored or co-authored, including articles and book chapters. His studies have contributed to invitations to lecture both nationally and internationally. Dr. Gerber serves on several committees at UT Southwestern. Beyond the institution, he serves as Chair of the Clinical Trials Advisory Committee for the Cancer Prevention and Research Institute of Texas (CPRIT) and is a member of the National Comprehensive Cancer Network (NCCN) Oncology Research Program Investigator Steering Committee. Dr. Gerber holds memberships in several professional organizations, and he has been honored with numerous awards, including being named a Best Doctor in Dallas by D Magazine during the years of 2011-2023. Learn more about Dr. Gerber and his research.
