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Early-phase clinical trials in the community: results from the national cancer institute community cancer centers program early-phase working group baseline assessment.

2013 Mar

Journal Article

Zaren, H.A.; Nair, S.; Go, R.S.; Enos, R.A.; Lanier, K.S.; Thompson, M.A.; Zhao, J.; Fleming, D.L.; Leighton, J.C.; Gribbin, T.E.; Bryant, D.M.; Carrigan, A.; Corpening, J.C.; Csapo, K.A.; Dimond, E.P.; Ellison, C.; Gonzalez, M.M.; Harr, J.L.; Wilkinson, K.; Denicoff, A.M.

J Oncol Pract






Cancer Care Facilities; Clinical Trials as Topic; Community health services; Humans; Multicenter Studies as Topic; National Cancer Institute (U.S.); Neoplasms; Program Evaluation; United States

PURPOSE: The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) formed an Early-Phase Working Group to facilitate site participation in early-phase (EP) trials. The Working Group conducted a baseline assessment (BA) to describe the sites' EP trial infrastructure and its association with accrual.METHODS: EP accrual and infrastructure data for the sites were obtained for July 2010-June 2011 and 2010, respectively. Sites with EP accrual rates at or above the median were considered high-accruing sites. Analyses were performed to identify site characteristics associated with higher accrual onto EP trials.RESULTS: Twenty-seven of the 30 NCCCP sites participated. The median number of EP trials open per site over the course of July 2010-June 2011 was 19. Median EP accrual per site was 14 patients in 1 year. Approximately half of the EP trials were Cooperative Group; most were phase II. Except for having a higher number of EP trials open (P = .04), high-accruing sites (n = 14) did not differ significantly from low-accruing sites (n = 13) in terms of any single site characteristic. High-accruing sites did have shorter institutional review board (IRB) turnaround time by 20 days, and were almost three times as likely to be a lead Community Clinical Oncology Program site (small sample size may have prevented statistical significance). Most sites had at least basic EP trial infrastructure.CONCLUSION: Community cancer centers are capable of conducting EP trials. Infrastructure and collaborations are critical components of success. This assessment provides useful information for implementing EP trials in the community.

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