ArticleClinical cancer research : an official journal of the American Association for Cancer Research2025
Development, Review, and Activation of Thoracic Oncology Investigator-Initiated Trials.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
14 authors.
Funding
Abstract
purposeInvestigator-initiated trials (IIT) 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. EXPERIMENTAL
designWe performed a retrospective study of IIT concepts submitted through the Academic Thoracic Oncology Medical Investigators Consortium, which comprises 13 institutions in the United States and Canada, from consortium inception in 2014 to 2024. We compared approved and disapproved concepts using χ2 tests, Fisher exact tests, and Wilcoxon rank-sum tests.
resultsAmong 68 presented IIT concepts, 60 (88%) received consortium approval a median of 30 days (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, the median overall time from initial submission to trial activation was 18 months.
conclusionsOnly 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.
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