Clinical Trials in the Academic Cancer Center

Figure 1
Figure 1

(A) Aggregate distribution of patient accruals to therapeutic trials, by sponsor. A total of 16,018 patient accruals were reported. (B) Aggregate distribution of sponsorship for all active therapeutic clinical trials. A total of 6,097 trials were reported.

Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 9, 11; 10.6004/jnccn.2011.0107

The 2010 NCCN Research Benchmarking Survey focused on therapeutic clinical trial volume and accrual rates at NCCN Member Institutions. The primary aim was to benchmark clinical trials activity, including trial sponsorship, patient accrual, and the steps involved in protocol review. The survey collected quantitative and descriptive data on therapeutic trials, accruals, and sponsors. In addition, because the steps required for activation of clinical trials may result in delays and increase costs, the 2010 survey collected information on the processes and timeframes involved in protocol review.

Of newly reportable patients (105,917) from 20 NCCN Member Institutions reporting accruals over a 12-month period, 16,018 (15.1%) were recruited to therapeutic clinical trials (Figure 1A); 6,097 therapeutic trials (all phases) were reported (Figure 1B). Accruals per trial were calculated using total accruals and the aggregate number of therapeutic trials reported by each participating NCCN Member Institution. Accrual to multisite trials was analyzed at the institutional-level to ensure comparability among trials with different sponsors. (Note: Multisite trials open to accrual at more than one center were not cross-referenced for the purpose of this analysis.)

The average number of accruals per trial (all sponsors) was 2.63 (16,018 accruals/6,097 trials). The NCI Cooperative Groups (CGs) sponsored 39% of trials (2,367/6,097), with 19.7% (3,151/16,018) of patient accruals attributed to NCI CG trials (1.33 accruals per trial). Comparatively, 22% of trials (1,364/6,097) were institutionally sponsored, accounting for 39.6% of accruals (6,345/16,018) to these trials (4.65 accruals per trial). Thirty percent of trials (1,827/6,097) were industry sponsored and accounted for 27% of accruals (4,328/16,018), or 2.37 accruals per trial. Other peer-reviewed mechanisms accounted for the balance of trials and accruals. A broad range of timelines were reported for the steps involved in protocol review and activation, indicating that 1) there are likely best practices that merit investigation, and 2) further refinement and standardization of timeline definitions are warranted.

Clinical research constitutes a core mission of NCCN centers. NCCN benchmarking efforts are undertaken to improve clinical trials operations and ultimately to impact the development of new therapies and their delivery to patients. Accruals per trial for all sponsors appear low; the observed per-center rate of 1.33 accruals per trial to NCI CG–sponsored studies is of particular concern. Further development of benchmarks and best practices will promote enhanced operations, timely review processes, and increased patient accrual.

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References

1

Sherman SL, Waldinger MB, Paul DE. The 2010 National Comprehensive Cancer Network Research Benchmarking Survey: clinical trials in the academic cancer center [abstract]. Presented at ASCO 2011 Annual Meeting; June 4, 2011; Chicago, IL. Abstract 6116.

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    (A) Aggregate distribution of patient accruals to therapeutic trials, by sponsor. A total of 16,018 patient accruals were reported. (B) Aggregate distribution of sponsorship for all active therapeutic clinical trials. A total of 6,097 trials were reported.

  • 1

    Sherman SL, Waldinger MB, Paul DE. The 2010 National Comprehensive Cancer Network Research Benchmarking Survey: clinical trials in the academic cancer center [abstract]. Presented at ASCO 2011 Annual Meeting; June 4, 2011; Chicago, IL. Abstract 6116.

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