title: Challenges in credentialing institutions and participants in advanced technology multi-institutional clinical trials.
abstract: 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.
authors.affiliation: Radiological Physics Center, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77030, USA. gibbott@manderson.org
authors.forename: Geoffrey S
authors.initials: GS
authors.lastname: Ibbott
authors.forename: David S
authors.initials: DS
authors.lastname: Followill
authors.forename: H Andrea
authors.initials: HA
authors.lastname: Molineu
authors.forename: Jessica R
authors.initials: JR
authors.lastname: Lowenstein
authors.forename: Paola E
authors.initials: PE
authors.lastname: Alvarez
authors.forename: Joye E
authors.initials: JE
authors.lastname: Roll
mesh_terms: D001291:Attitude of Health Personnel; D001918:Brachytherapy / Q000592:standards; D002173:Cancer Care Facilities / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards; D003406:Credentialing / Q000592:standards*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards*; D018787:Radiation Oncology / Q000592:standards*; D016634:Radiosurgery / Q000592:standards; D020266:Radiotherapy, Conformal / Q000592:standards; D050397:Radiotherapy, Intensity-Modulated / Q000592:standards; D014481:United States