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
2013
Authors
Zaren, HA; Nair, S; Go, RS; Enos, RA; Lanier, KS; Thompson, MA; Zhao, J; Fleming, DL; Leighton, JC; Gribbin, TE; Bryant, DM; Carrigan, A; Corpening, JC; Csapo, KA; Dimond, EP; Ellison, C; Gonzalez, MM; Harr, JL; Wilkinson, K; Denicoff, AM
Secondary
J Oncol Pract
Volume
9
Start Page
e55
Pagination
e55-e61
Date Published
03/2013
Keywords
Diabetes & Women's Health study; environmental factors; genetic factors; Gestational Diabetes; glucose tolerance test; impaired glucose tolerance; metabolism; Pregnancy; type 2 diabetes
ISBN
1935469x
Abstract

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.