Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr 6154)
Author(s): S. L. Sherman, M. B. Waldinger, E. M. Lepisto, J. M. Hinkel, K. A. Minogue, D. E. Paul; National Comprehensive Cancer Network, Fort Washington, PA; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI
Background: The 2008 NCCN RBS focused on the operations of clinical trials offices (CTOs) at NCCN Institutions. The survey utilized clinical trials benchmarking metrics based on CTO budgets, full-time equivalents (FTEs), and patient accruals. The primary aims were benchmarking and improvement of CTO operations and processes and identification of best practices in academic cancer center clinical research.
Methods: A survey instrument was developed by the NCCN Best Practices Committee based on prior 2004 and 2006 surveys, which will allow for future analysis of longitudinal data. The survey collected quantitative and descriptive data on CTO organization, research infrastructure, staffing and clinical trials management, and included questions on innovative approaches to increasing accrual to CTs.
Results: 20/21 NCCN institutions participated, for a response rate of 95%. The proportion of therapeutic trials varied across sponsor (mean, range): Cooperative Group (42%, 24%-66%), Industry Sponsored (29%, 18%-38%), Institutional (19%, 8-33%), Other Peer Reviewed (10%, 2%-27%). Of the 17/20 responding centers submitting patient accrual data, over 16,000 patients were accrued to therapeutic CTs. Patients were accrued to CTs as follows: Institutional (34%), Industry Sponsored (27%), Cooperative Group (23%) and Other Peer Reviewed (16%). CT accrual rates ranged from 10% to 24%; minority accrual rates ranged from 6 to 28 %. The mean annual operating budget for 15 centers was $4.7 million. The range of sources of support for CT management was from 43% for Sponsored Industry to 5% for Sponsored Cooperatives. The mean number of therapeutic accruals per CTO FTE was 10.6. 7/20 (35%) centers demonstrated Best Practices in implementing a value stream analysis of the protocol approval process.
Conclusions: Clinical Research is at the heart of NCCN center operations, as it constitutes a core mission of NCCN institutions. It also represents one of the most significant challenges with many opportunities for improvement. Development of benchmark data and Best Practices across these institutions will promote enhanced operations and patient accrual in therapeutic CTs.