Early-phase (EP) clinical trials (CTs) in the community: Results from the National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) Early-Phase Working Group (EPWG) Baseline Assessment Study (BAS).

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Background: The NCCCP is a network of 30 community cancer center (CCC) sites that strive to expand cancer research capacity and deliver advanced care in the community. The EPWG was formed to facilitate NCCCP site participation in EP (phase I-II) CTs, thus allowing patients (pts) to be treated within their communities. This study describes the CT infrastructure at NCCCP sites and its association with EP accrual. Methods: A BAS was conducted to obtain data on NCCCP site CT infrastructure, funding, sponsor affiliations, and barriers to EP CTs. To evaluate EP performance, EP accruals during July 2010-June 2011 were obtained. High accruing sites were those with EP accrual above the median EP accrual per 1,000 new analytical cases seen in 2009 or 2010. Results: 27 sites, caring for ~56,000 new cancer pts annually, participated in the study. Median number of accruing EP trials/site was 6 (mean 7.4). Median EP accrual/site was 14 (mean 16). Median EP accrual rate was 7/1,000. Trials with a phase I component were open at 21 sites. Most sites (24) are members of multiple CGs (median 4) and enroll pts via the CTSU (70%). The more common barriers to EP trial implementation were related to infrastructure (59%), cost (52%), and access to trials (41%). When accrual rates to NCCCP CTEP EP trials only were analyzed, we found that between high vs low accruing sites, respectively, higher accrual rates were associated with higher number of CRAs devoted to EP trials (median 3.25 vs 1; P= .05) and lower proportion of funding from industry (median 18% vs 40%; P=.02). We did not, however, find significant associations when EP trials were examined across all sponsors. Conclusions: CCCs are capable of conducting, and actively participating in, EP trials. Infrastructure and collaborations are critical components of success. Our study provides useful information for those planning to begin EP trials in the community setting.


This abstract was not be presented at the 2012 ASCO Annual Meeting but has been published in conjunction with the meeting.

J Clin Oncol 30, 2012 (suppl; abstr e16561).


Hematology | Medical Sciences | Medicine and Health Sciences | Oncology


Department of Medicine, Hematology-Medical Oncology Division

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