By Stephen Sherman, Program Manager, Best Practices and Megan Martin, Communications Manager
Clinical research constitutes a core mission of NCCN Member Institutions. Although clinical trials are the cornerstone for advancing treatments in cancer, recruitment to clinical trials remains a considerable challenge even for leading NCCN academic cancer centers. To gain insight into the operations of Clinical Trials Offices (CTOs), protocol review processes, and patient accrual to clinical trials, NCCN conducted a Research Benchmarking Survey at NCCN Member Institutions in 2008 (reporting on 2007 data). Results from the survey were presented in poster format at the 2010 ASCO Annual Meeting in Chicago on June 7, 2010.
The 2008 NCCN Research Benchmarking Survey utilized clinical trials benchmarking metrics based on CTO budgets, full-time equivalents (FTEs), and patient accruals. The primary goal was to benchmark CTO operations and processes at NCCN Member Institutions, for the purpose of identifying best practices in clinical research operations at academic cancer centers. The survey collected quantitative and descriptive data on patient accrual, CTO organization, research infrastructure, staffing, and clinical trials management. It also included questions on innovative approaches designed to increase accrual to clinical trials.
Overall, the Research Benchmarking Survey revealed that cooperative groups sponsored most of the clinical trials (42 percent), followed by industry (29 percent), then the individual institution (19 percent). Other Peer-Reviewed trials constituted 10 percent of the active clinical trials (see Figure 1). These proportions varied at the institution level, with the ranges of proportions as follows: cooperative group, 24-66 percent; industry sponsored, 18-38 percent; institutional 8-33 percent; other peer-reviewed, 2-27 percent. Results from 17 participating NCCN Member Institutions that submitted patient accrual data indicate that 16,327 patients were accrued to therapeutic clinical trials over a 12-month reporting period, translating to accrual rates ranging from 10 to 24 percent. Of these participants, minority accrual rates ranged from 6 to 28 percent. The proportion of patients that accrued to clinical trials sponsored by the Institution, Industry, Cooperative Group, and Other Peer Reviewed was 34 percent, 27 percent, 23 percent, and 16 percent, respectively (see Figure 2).
Other findings of the study observed that the average CTO operating budget for 15 NCCN Member Institutions that provided funding information was $4.7 million, while the mean number of therapeutic accruals was 10.6 patients per CTO FTE. However, there was a wide range of CTO costs per therapeutic accrual among institutions, thus warranting further exploration. It is unclear what proportion of variation is due to differences among institutions in efficiency, operations, and/or in the characteristics of the clinical trials being managed by the CTO. Seven of the participating centers demonstrated best practices in implementing a value stream analysis of the protocol approval process. Value stream mapping is a process analysis and improvement technique used to analyze the flow of materials and information required to bring a product or service to a patient.
NCCN is currently conducting a 2010 version of the Research Benchmarking Survey. This survey has been refined to better evaluate the steps involved and overall timetable to open clinical trials, from protocol submission to patient accrual. NCCN plans to undertake longitudinal analyses of common data among the 2008 and 2010 Research Benchmarking Surveys.