Successful coordination and execution of nontherapeutic studies in a cooperative group setting: Lessons learned from Children's Oncology Group studies
Successful coordination and execution of nontherapeutic studies in a cooperative group setting: Lessons learned from Children's Oncology Group studies
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DOI：
10.1158/1055-9965.epi-07-2862
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发表时间：
2008-07-01
影响因子：
3.8
通讯作者：
Bhatia, Smita
中科院分区：
文献类型：
--
作者：
Carter, Andrea;Landier, Wendy;Bhatia, Smita
儿童癌症存活率的巨大进步是由于利用国家合作团体开发的基础设施，系统和有效地进行了大型多中心治疗试验。这些治疗试验取得了成功，部分原因是参与成员机构的参与率很高。然而，由于各种原因，如缺乏机构资源，在合作小组环境中参与非治疗性试验落后于治疗性试验，导致对此类活动的重视程度较低。本报告的目的是分享协调中心（City of Hope National Medical Center）开发并成功实施的一些方法，以最大限度地提高机构参与和患者入组，并规范数据收集和质量控制，以确保成功执行两项大型的，由壁外资助的合作组非治疗性研究。到目前为止，超过175家机构已经获得了监管机构对本文所展示的协议的批准，权责发生制已经达到目标，收集的数据的完整性和质量都非常好。这些非治疗性研究的成功实施显示了多样化的研究宣传技术、详细的标准化操作程序和有效利用技术资源的优势。
The immense progress made in childhood cancer survival has been due to the systematic and efficient conduct of large multicenter therapeutic trials, using the infrastructure developed by national cooperative groups. These therapeutic trials have been successful, in part due to the high participation rates by the participating member institutions. However, participation in nontherapeutic trials in the cooperative group setting has lagged behind that of therapeutic trials for a variety of reasons, such as lack of institutional resources, leading to low priority given to such activities. The purpose of this report is to share some of the methods developed and successfully implemented by a coordinating center (City of Hope National Medical Center) to maximize institutional participation and patient enrollment and to standardize data collection and quality control, in order to ensure the successful execution of two large, extramurally funded, cooperative group nontherapeutic studies. To date, over 175 institutions have obtained regulatory approval for the protocols showcased here, accrual has been on target, and completeness and quality of the collected data have been excellent. The successful execution of these nontherapeutic studies shows the advantages of diverse study publicity techniques, detailed standardized operating procedures, and effective utilization of technological resources.