Saphner Thomas, Thompson Michael A, Planton Sara, Singh Maharaj, Glandt Neha, Robinson Lisa, DeBartolo Jan
WMJ. 2016 Aug;115(4):191-5.
The new National Cancer Institute (NCI) Community Oncology Research Program (NCORP) went live August 1, 2014; 34 sites were selected for the program, including 7 new sites that previously did not have a research grant from the NCI. This report describes the first year of a new program site.
Accrual, investigator and site participation, and number of open studies by the program over the first 12 months of the grant were compared to performance at our institution over the prior 12 months.
During the pre-NCORP period, 84 patients were accrued to NCI-sponsored trials and 106 patients to non–NCI-sponsored trials. In year 1 of the new program, 140 were accrued to NCI-sponsored trials—a 66% improvement, and 109 patients to non–NCI-sponsored trials (P = 0.013 when comparing corresponding increases for NCI vs non-NCI trials). Success of the NCI-sponsored trials was associated with increased accrual to both treatment trials (P = 0.03) and Alliance for Clinical Trials in Oncology-sponsored trials (P = 0.0001).
NCORP implementation was associated with a significant (P = 0.013) improvement in accrual to NCI-sponsored trials that was immediate (1 year) and large (a 66% increase in accrual). In year 2, the intention is to increase cancer control studies; foster inclusion of radiation, surgical, gynecologic, and neurologic oncologists; and focus on minority outreach. Studies that accrue poorly will be assessed, and those accruing poorly on a national basis will be considered for closure. Studies accruing well nationally will be evaluated for barriers to local accrual.
新的美国国立癌症研究所(NCI)社区肿瘤学研究项目(NCORP)于2014年8月1日启动;该项目选定了34个研究点,其中包括7个此前未获得NCI研究资助的新研究点。本报告描述了一个新的项目研究点的第一年情况。
将该资助项目头12个月的入组人数、研究者及研究点参与情况和开放研究数量,与我们机构此前12个月的表现进行比较。
在NCORP项目启动前的时期,有84例患者入组了由NCI资助的试验,106例患者入组了非NCI资助的试验。在新项目的第1年,有140例患者入组了由NCI资助的试验,增加了66%,109例患者入组了非NCI资助的试验(比较NCI与非NCI试验的相应增长时,P = 0.013)。由NCI资助的试验的成功与治疗试验(P = 0.03)和肿瘤临床试验联盟资助的试验(P = 0.0001)的入组人数增加相关。
NCORP项目的实施与NCI资助试验的入组人数显著(P = 0.013)改善相关,这种改善是即时的(1年)且幅度很大(入组人数增加了66%)。在第2年,计划增加癌症控制研究;促进放射肿瘤学家、外科肿瘤学家、妇科肿瘤学家和神经肿瘤学家的参与;并专注于拓展少数族裔群体。将对入组情况不佳的研究进行评估,对全国范围内入组情况不佳的研究将考虑予以关闭。对全国范围内入组情况良好的研究将评估其在当地入组的障碍。