Early-Phase Clinical Trials in the Community: Results from the National Cancer Institute Community Cancer Centers Program Early-Phase Working Group Baseline Assessment
Mar-13
Journal Article
Authors:
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.
Secondary:
J Oncol Pract
Volume:
9
Pagination:
e55-e61
URL:
http://www.ncbi.nlm.nih.gov/pubmed/23814525
Abstract:
<p>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.</p>