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

Publication Type
Journal Article
Year of Publication
Zaren, Howard A; Nair, Suresh; Go, Ronald S; Enos, Rebecca A; Lanier, Keith S; Thompson, Michael A; Zhao, Jinxiu; Fleming, Deborah L; Leighton, John C; Gribbin, Thomas E; Bryant, Donna M; Carrigan, Angela; Corpening, Jennifer C; Csapo, Kimberly A; Dimond, Eileen P; Ellison, Christie; Gonzalez, Maria M; Harr, Jodi L; Wilkinson, Kathy; Denicoff, Andrea M
J Oncol Pract
Date Published
2013 Mar
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.