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了解国家癌症研究所指定社区肿瘤学研究项目中儿科肿瘤学家参与和入组临床试验的障碍。

Understanding the Barriers to Pediatric Oncologist Engagement and Accrual to Clinical Trials in National Cancer Institute-Designated Community Oncology Research Programs.

机构信息

Department of Pediatrics, Division of Hematology, Oncology and Bone Marrow Transplantation, University of Iowa, Holden Comprehensive Cancer Center, Iowa City, IA.

Department of Pediatrics Patient Care, Division of Pediatrics, The University of Texas MD Anderson Cancer Center, Houston, TX.

出版信息

JCO Oncol Pract. 2020 Oct;16(10):e1060-e1066. doi: 10.1200/JOP.19.00707. Epub 2020 May 12.

Abstract

PURPOSE

Clinical trial participation leads to progress in cancer care. Principal investigators (PIs) and clinical research associates (CRAs) play key roles in the provision and maintenance of clinical trial portfolios at their sites. Previous studies have evaluated the educational and resource needs of adult oncology providers, but nothing to date has focused on providers of pediatric oncology care. We aimed to identify the educational needs and clinical trial participation barriers at National Cancer Institute Community Oncology Research Program (NCORP) Children's Oncology Group (COG) sites to improve the quality of site investigator engagement.

METHODS

Quality improvement surveys of pediatric clinical research staff at NCORP sites were performed. The first was a web-based inquiry of NCORP COG PIs and lead CRAs to assess their general understanding of NCORP organizational structure and needs. The second survey of COG PIs was conducted by one-on-one telephone interviews aimed at identifying specific barriers to physician engagement and patient enrollment in clinical trial research.

RESULTS

The majority of NCORP COG PIs and CRAs (63%) reported an incomplete understanding of NCORP structure, with approximately half expressing interest in developing stronger collaborations and engagement. Most NCORP COG PIs reported at least one shared barrier to clinical trial enrollment (78%), with inadequate protected time and research support (39% each) being the most frequently cited barriers.

CONCLUSIONS

Contributions to pediatric cancer clinical research at COG NCORP sites could be enhanced through improved education, resources, and time allocation.

摘要

目的

临床试验参与推动癌症治疗的进步。主要研究者(PI)和临床研究助理(CRA)在其所在机构提供和维护临床试验组合方面发挥着关键作用。先前的研究评估了成人肿瘤学提供者的教育和资源需求,但迄今为止,尚无专门针对儿科肿瘤学护理提供者的研究。我们旨在确定国家癌症研究所社区肿瘤学研究计划(NCORP)儿童肿瘤学组(COG)站点的教育需求和临床试验参与障碍,以提高现场研究者参与的质量。

方法

对 NCORP 站点的儿科临床研究人员进行了质量改进调查。第一项是对 NCORP COG PI 和首席 CRA 进行的基于网络的调查,以评估他们对 NCORP 组织结构和需求的总体了解。第二项针对 COG PI 的调查是通过一对一的电话访谈进行的,旨在确定医生参与和患者入组临床试验的具体障碍。

结果

大多数 NCORP COG PI 和 CRA(63%)报告说他们对 NCORP 结构的理解不完整,约有一半表示有兴趣加强合作和参与。大多数 NCORP COG PI 报告了至少一个共同的临床试验入组障碍(78%),其中保护时间不足和研究支持不足(各占 39%)是最常提到的障碍。

结论

通过改进教育、资源和时间分配,可以增强 COG NCORP 站点的儿科癌症临床研究贡献。

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