Quality Assurance Review Center
|Industry||Quality assurance, Clinical trials|
|Products||Diagnostic imaging data management, Cancer research|
The Quality Assurance Review Center (QARC) is a research program within the University of Massachusetts Medical School (UMMS) that provides radiotherapy (RT) quality assurance (QA), diagnostic imaging data management, and clinical research support. Located in Lincoln, Rhode Island, QARC is a nationally and internationally recognized program serving the National Cancer Institute (NCI)-sponsored cooperative groups and industry partners. These cooperative groups and their industry partners conduct a wide variety of clinical trials in order to evaluate the overall effectiveness of protocol-driven cancer treatment strategies.
The history of QARC can be traced back to the late 1970s when Rhode Island Hospital was conducting RT QA reviews of leukemia-based protocols for the CALGB, which is one of the major NCI-sponsored cooperative groups. Due to the quality management of the CALGB's trials, other cooperative groups like the Pediatric Oncology Group (POG) and the Children's Cancer Study Group (CCG) decided to ensure the quality of their respective trials through the auspices of QARC. It was at this time that QARC began to seek funding from the NCI in order to manage the large influx of RT data. By 1980, QARC had received its first grant monies from the NCI, as it expanded to cover a wider array of protocol-based studies. Over the course of the next fifteen years of so, QARC began to implement a series of changes to the retrospective review process, especially with regard to its Physics/Dosimetry division. In 1996, QARC switched its affiliation from the Brown University School of Medicine to UMass Medical School. By late 2003, QARC moved from its former location at the Roger Williams Medical Center (RWMC) to offices in Providence's Federal Hill neighborhood. And in August 2010, QARC relocated to its current site on the George Washington Highway in Lincoln.
The QARC mission is to improve the standard of care in the management of cancer by ensuring quality. Providing radiotherapy quality assurance is essential for ensuring the validity of data across multi-disciplinary cooperative group trials. QARC employs a methodology that is responsive and supportive of the National Cancer Clinical Trials Enterprise. As radiotherapy evolves in the area of image-based, target volume definitions, and as digital information continues to supplant hard-copy formats for both diagnostic imaging and RT data, QARC continually strives to support these developments. And with today's advanced technologies in the areas of motion management and other real-time delivery modifications, meeting the growing demand for quality assurance in the ever-expanding field of cancer treatment is a top priority for QARC.
The Administration division is predominantly focused on constructing and sustaining working relationships between QARC and the various NCI supported oncology groups as well as the pharmaceutical industry. It collaborates with the UMass Medical School in matters pertaining to accounting, employment, and professional development. One previous clinical trial that was organized by the division involved French drugmaker Sanofi-Aventis and the experimental chemotherapeutic agent tirapazamine. Most of the major NCI-sponsored cooperative groups are mandated to send their radiotherapy materials to QARC for review, and they include ACOSOG, COG, ECOG, SWOG, and CALGB.
The Clinical division primarily consists of various diagnostic and therapeutic radiologists who conduct both real time and retrospective reviews. In the five years since 2003, QARC has performed interventional RT reviews for over 6,000 protocol-enrolled patients.
The Data Management division receives and processes all forms of data relating to a particular patient and the corresponding protocol. Typical forms of data include diagnostic imaging, physics benchmarks, and radiology reports. The diagnostic imaging segment of data management usually involves computed tomography (CT), positron emission tomography (PET), and magnetic resonance imaging (MRI) scans. Occasionally, QARC will obtain gallium and bone scans insofar as a protocol mandates them. With the shift in nuclear medicine toward electronic medical records (EMRs), DM works closely with IS to maintain QARC's digital database.
The Information Systems division maintains and upgrades QARC's digital database. As of 2008, the QARC database contained records on over 40,000 patients enrolled on more than 200 protocols. The RT information and diagnostic imaging data stored on QARC's servers is submitted from around 1,000 hospitals in both the United States and abroad.
The Physics/Dosimetry division is mostly concerned with evaluating the radiation dose calculations submitted with each patient on a protocol. In addition, the division works closely with various institutions, which include the cooperative oncology groups and the pharmaceutical industry partners, to develop and implement new benchmarks for specific areas of radiation therapy. In keeping with its responsibility as a quality assurance agent, the division participates in initial, interventional, and final reviews so as to assure a high degree of integrity with regard to protocol guidelines.
- Protocol Development
- Site Credentialing
- Data Acquisition
- Case Management & Archiving
- Diagnostic & Therapeutic Radiology Case Review
- Institutional Performance Evaluation & Reporting
- Research & Publications
Notes and references
- "Center for Clinical and Translational Science" - UMass Medical School
- UMMS Department of Radiation Oncology
- "Funded Research Portfolio" - National Cancer Institute
- "About QARC" - Quality Assurance Review Center
- "TRACE: Tirapazamine-Radiation And Cisplatin Evaluation" - National Institutes of Health
- "Revamped quality assurance approach embarks on a new era in clinical trials" - Cancer Network