Challenges in credentialing institutions and participants in advanced technology multi-institutional clinical trials
Challenges in credentialing institutions and participants in advanced technology multi-institutional clinical trials
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DOI：
10.1016/j.ijrobp.2007.08.083
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发表时间：
2008-01-01
影响因子：
7
通讯作者：
Roll, Joys E.
中科院分区：
文献类型：
--
作者：
Ibbott, Geoffrey S.;Followill, David S.;Roll, Joys E.
放射物理中心（RPC）已经连续运作了38年，以确保国家癌症研究所和合作团体，参与多机构试验的机构可以预期提供的放射治疗在临床上与合作团体中的其他机构提供的放射治疗相当。为了实现这一点，RPC监测机器输出、机构使用的剂量测定数据、用于治疗计划的计算算法以及机构的质量控制程序。监测方法包括RPC物理学家进行的现场剂量测定审查和各种远程审计工具。先进技术临床试验的引入促使几个研究小组要求参与机构和人员获得资格证书，以确保他们熟悉三维适形放射治疗、调强放射治疗、立体定向体部放射治疗和近距离放射治疗等技术。RPC进行各种认证活动，首先是问卷调查，以评估机构对协议的理解及其能力。治疗计划基准用于使机构能够证明其计划能力，并便于在相关条件下审查治疗计划系统的准确性。RPC还提供可邮寄的拟人幻影，以验证特殊治疗技术的肿瘤剂量递送。在进行这些审查的同时，RPC收集了大量描述参与机构剂量测定的数据。代表性的数据从监测方案进行了讨论，并提出了具体的实例中，RPC有助于剂量测定误差的发现和解决。(C)2008年爱思唯尔公司
The Radiological Physics Center (RPC) has functioned continuously for 38 years to assure the National Cancer Institute and the cooperative groups that institutions participating in multi-institutional trials can be expected to deliver radiation treatments that are clinically comparable to those delivered by other institutions in the cooperative groups. To accomplish this, the RPC monitors the machine output, the dosimetry data used by the institutions, the calculation algorithms used for treatment planning, and the institutions' quality control procedures. The methods of monitoring include on-site dosimetry review by an RPC physicist and a variety of remote audit tools. The introduction of advanced technology clinical trials has prompted several study groups to require participating institutions and personnel to become credentialed, to ensure their familiarity and capability with techniques such as three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, stereotactic body radiotherapy, and brachytherapy. The RPC conducts a variety of credentialing activities, beginning with questionnaires to evaluate an institution's understanding of the protocol and their capabilities. Treatment-planning benchmarks are used to allow the institution to demonstrate their planning ability and to facilitate a review of the accuracy of treatment-planning systems under relevant conditions. The RPC also provides mailable anthropomorphic phantoms to verify tumor dose delivery for special treatment techniques. While conducting these reviews, the RPC has amassed a large amount of data describing the dosimetry at participating institutions. Representative data from the monitoring programs are discussed, and examples are presented of specific instances in which the RPC contributed to the discovery and resolution of dosimetry errors. (C) 2008 Elsevier Inc.