Development, Review, and Activation of Thoracic Oncology Investigator-Initiated Trials.

ABSTRACT:

Purpose

Investigator-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 design

We 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.

Results

Among 68 presented IIT concepts, 60 (88%) received consortium approval a median of 30 days (IQR, 31-59 days) after submission. Concepts submitted

SUBMITTER: Gerber DE 

PROVIDER: S-EPMC11913578 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature