CCSG - Administrative Supplement-ETCTN EDDOP (Accruals) - 2020

University Of Chicago, Chicago IL

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY This application is being submitted in response to the NOSI identified as NOT-CA-20-017. This application supports participation of the University of Chicago Medicine Comprehensive Cancer Center (UCCCC) in the Early Therapeutics-Clinical Trials Network (ETCTN) to provide access by NCI Cancer Centers to agents under NCI development. The UCCCC has been affiliated with the ETCTN since 1988, first through a Phase 1 U01 funding mechanism, then under NCI contracts to perform Early Therapeutics Development with Phase 2 Emphasis and then through an ETCTN UM1 grant that ended 3/1/16. Since 6/6/16, the UCCC has continued its affiliation with the ETCN through the EDDOP mechanism, having accrued 43 patients across 14 trials. More broadly, the UCCCC maintains an active and robust early therapeutics clinical research program. Specifically, in calendar year 2019, a total of 723 patients were accrued to therapeutic clinical trials, of which 590 were Phase 1, Phase 1/2 or Phase 2 trials across all the major disease areas. Notably, underrepresented minorities constituted 22.5% of all accruals, 27% of early phase trials were investigator initiated, and of these, 65% were multi-institutional. The UCCCC and its investigators conform to all ETCTN processes and procedures, including the use of the Central IRB, the OPEN registration system, Medidata Rave for data management, and CTEP-AERS for adverse event reporting.