TT17-Physics QA for Clinical Trials ‑ Experience from 35 Years of Monitoring
4H04-Physics QA for Clinical Trials ‑ Experience from 35 Years of Monitoring
Geoffrey S. Ibbott, PhD
Radiation Physics Dept.
UT M.D. Anderson Cancer Center
Box 547
1515 Holcombe Blvd
Houston, TX 77030
The treatment received by all patients that are treated on clinical trials must be clinically comparable in order for the study to arrive at scientifically meaningful results. The radiotherapy community recognized this need to standardize the technical aspects of radiation treatment in 1968. At the urging of the Committee on Radiation Therapy Studies (CRTS) and the American Association of Physicists in Medicine (AAPM), the NCI funded the Radiological Physics Center in 1969, and has funded it continuously since then. Today 1,338 megavoltage therapy facilities are monitored by the RPC for participation in one or more of the hundreds of protocols sponsored by roughly a dozen cooperative groups presently active and their intergroup activities. Most of these institutions are in North America, but a number of them are located in other countries.
The RPC's responsibility is to assure that institutions participating in cooperative clinical trials have acceptable quality assurance programs and no major technical discrepancies. This assurance is necessary so that the cooperative groups can focus their efforts on evaluation of the clinical aspects, and on any dosimetry aspects that are of particular importance to specific protocols. In 35 years, the RPC has accumulated a wealth of experience and data regarding the quality of radiation treatments in the US and throughout the world.
TT17-临床试验中的物理质量保证-35年监测经验
4H04-临床试验中的物理质量保证-35年监测经验
Geoffrey S. Ibbott, PhD
Radiation Physics Dept.
UT M.D. Anderson Cancer Center
Box 547
1515 Holcombe Blvd
Houston, TX 77030
临床试验中所有病人所接受的治疗必须是在临床上可以比较的，这样才能用于研究以达到有科学意义的结果。放疗界1968年开始认识到这需要使放射治疗技术标准化。在CRTS和AAPM的促进下，NCI从1969年为放射物理中心提供资金至今。今天RPC还在监测1338台兆伏治疗设备。这些设备用于数百个临床试验中的一个或多个。这些临床试验是由大约十二个活跃的合作组织发起的。参加这些试验的单位大部分在北美，也有一部分在其他国家。
RPC的职责是保证参与联合临床试验的单位都有可接受的质量保证程序且没有主要的技术差异。这个保证是必需的，只有这样合作组才能够将精力集中在临床方面的评价和对特定临床试验有重要意义的剂量学方面的评价。在35年中，RPC积累了大量关于美国和全世界放射治疗质量的经验和数据。