Pollock B H
Department of Pediatrics, University of Florida, Gainesville.
Cancer. 1994 Nov 1;74(9 Suppl):2647-52. doi: 10.1002/1097-0142(19941101)74:9+<2647::aid-cncr2820741811>3.0.co;2-x.
Quality assurance for the management of multicenter clinical trials requires timely patient and data accrual and consistency with design parameters. Data from central pathology review, treatment modality, and follow-up as well as trial end points direct the selection of appropriate compliance measures. To integrate these data to monitor group performance on a specific protocol, to monitor discipline performance, or to monitor an institution's performance is a formidable task. This is especially true for a group such as the Pediatric Oncology Group, where there are a large number of protocols, many diseases, and widely differing protocol requirements. Quality assurance methods for the Pediatric Oncology Group are discussed.
多中心临床试验管理的质量保证要求及时招募患者和收集数据，并与设计参数保持一致。来自中央病理学审查、治疗方式、随访以及试验终点的数据指导着适当合规措施的选择。整合这些数据以监测特定方案的组表现、监测学科表现或监测机构表现是一项艰巨的任务。对于像儿科肿瘤学组这样的团体来说尤其如此，该团体有大量的方案、多种疾病以及差异很大的方案要求。本文讨论了儿科肿瘤学组的质量保证方法。
