A Brief History of Cooperative Group Clinical Trial Quality Assurance
In 1969 there were three cooperative groups, each with one protocol involving radiation therapy. Thirty-five megavoltage therapy facilities were participating in studies, and the RPC was the only group identified by NCI to monitor quality assurance.
In the early 1970s there was a major expansion in the number of cooperative groups and participating institutions. In 1974 there were 20 multidisciplinary cooperative groups with more than 200 megavoltage therapy institutions participating. In that same year the NCI Division of Cancer Control and Rehabilitation established six Centers of Radiological Physics (CRPs) to monitor the extension of modern diagnosis and radiotherapy to community hospitals. Although the originally defined functions and responsibilities were distinct from the RPC, very quickly community hospitals became involved in cooperative trials and the responsibilities of the CRPs and the RPC began to overlap. In 1977 the Quality Assurance Review Center (QARC) was established to assure quality of the radiotherapy treatment of individual patients entered onto the Cancer and Leukemia Group B (CALGB) studies. Other such quality assurance offices (QAO) were also funded, and by 1983 there were nine QAOs serving various cooperative groups.
In 1986 consolidation began when the NCI terminated the CRP contracts and subsequently supplemented the RPC to cover the additional institutions. In addition, only six QAO’s were left. There were now 600 radiotherapy facilities participating in clinical trials. Over the next ten years, cooperative group activity changed so that by 1996 there were only 9 cooperative groups and 4 QAO’s remaining, but more than 1050 participating radiotherapy facilities. In addition, the Proton Working Group and the 3-D QA Center were established to monitor high technology studies. In 2001, there were 8 cooperative groups, 3 QAO’s, and nearly 1300 radiotherapy facilities monitored by the RPC. The Image Guided Radiotherapy QA Center in St. Louis and the Resource Center for Emerging Technologies (RCET) in Gainesville were funded to establish databases of image guided radiotherapy treatments for cooperative groups and make that data available for evaluation.
From its beginning, the RPC quality assurance tools have included on-site dosimetry review visits to institutions, protocol patients’ chart reviews, and remote dose monitoring by TLD. In the early clinical protocols, only megavoltage photon therapy was allowed, so quality auditing by the RPC was limited to this modality. By 1977, electron beam therapy and brachytherapy had been introduced into cooperative studies, and, consequently, the RPC began to audit these modalities routinely. Today, with advances in therapy equipment including multileaf collimators and dynamic wedges, and advances in treatment techniques, including high dose rate brachytherapy, three-dimensional conformal radiotherapy, and intensity-modulated radiation therapy, the RPC has had to develop new auditing techniques. These include expanded measurements during on-site visits, mailable anthropomorphic phantoms, and increased computerization of all RPC activities.
When clinical trials involve advanced technologies, study groups often require institutions to pass an evaluation to demonstrate their ability to deliver the new technology safely and accurately. The RPC participates in developing and administering such evaluations, to credential institutions to participate in trials involving the use of three-dimensional conformal radiotherapy (3D CRT), high- and low-dose rate brachytherapy, intensity-modulated radiation therapy (IMRT), stereotactic radiosurgery (SRS), and other new technologies. Credentialing is conducted through the completion of questionnaires, knowledge assessments, performance of calculation benchmarks, and irradiation of anthropomorphic phantoms 2. The RPC's phantom evaluation program has proven to be a valuable and thorough test of an institution's ability to perform imaging procedures, develop a treatment plan, and deliver the plan to a phantom or patient using IMRT or SRS techniques.
When the RPC first started, there were no nationally or internationally promulgated calibration protocols. The first such protocols were SCRAD 3 (1971) for photon beams and ICRU #21 4(1972) for electron beams. In April 1984, the RPC adopted the AAPM Task Group 21 5 (1983) calibration protocol for photon and electron beams. In 1990, nearly 95% of institutions monitored by the RPC were using the AAPM Task Group 21 (TG-21), or equivalent, protocol. On January 1, 2000, the RPC implemented the new AAPM dosimetry calibration protocol, popularly known as TG-51 6 protocol (1999). RPC TLD results suggest that by April 2006, approximately 79% of RPC monitored facilities have converted to TG-51 and by 2010, 98% had converted.
There has been a marked improvement in radiation dosimetry over the past three decades, and the RPC has been monitoring it through its auditing tools. Between 1970 and 1980, the compliance rate (±3%) for beam calibration increased from approximately 70% to 90%. Improvement since then has been gradual, with compliance now near 98%, for both photons and electron beam calibrations. With the complexity of therapy increasing, discrepancies in other components of the treatment are more prevalent. During the past five years, approximately 90% of the institutions reviewed by an on-site review, had at least recommendation regarding dosimetry parameters.
As of 2010 the RPC staff includes six physicists, four dosimetrists, six TLD technologists, three computer system analysts, six administrative support staff, and four graduate students. The RPC currently monitors nearly 1,800 radiation therapy facilities in North America and internationally. Discrepancies detected by the RPC are investigated to help the institution resolve them. Thus, the RPC’s overall quality assurance program has an impact not only on the treatment received by patients enrolled in clinical trials, but also on the quality of treatment administered to all patients treated at the institution.
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