• Dr. Bruce Curran (ASTRO/IHE-RO)
• Dr. Walter Curran (RTOG/Emory)
• Dr. John Kalapurakal (COG)
• Dr. Robert Jeraj (ACRIN)
• Dr. Jean Moran (AAPM)
• Dr. Harry Quon (ECOG)
• Dr. Uma Ramamurthy (PBTC)
• Dr. Charles Thomas (SWOG)

The Advanced Technology Consortium (ATC) for Clinical Trials Quality Assurance is supported by a National Cancer Institute U24 grant to Washington University. It has grown out of the initial efforts of Washington University and the Radiation Therapy Oncology Group, beginning in 1994, to create a robust Quality Assurance process to collect and review the image-based planning and verification data for patients enrolled on the 3D Oncology Group (3DOG) prostate dose-escalation protocol (RTOG 9406). The original ATC grant (administered through Washington University, P.I. J.A. Purdy, Ph.D.) funding period was 1999-2002; the second funding period 2002-2007. The current ATC grant administered through Washington University (P.I. J.A. Purdy, Ph.D.) was successful in its competitive renewal application (funding period July 1, 2007 to June 30, 2012).

The ATC functions as a "virtual entity" made up of the following clinical trials QA Centers:

• Image-Guided Therapy QA Center (ITC - Washington Univ. in St. Louis and UC Davis),
• Radiation Therapy Oncology Group (RTOG) Headquarters Dosimetry Group,
• Radiological Physics Center (RPC, M.D. Anderson Cancer Center), and
• Quality Assurance Review Center (QARC).

The ATC capitalizes on the existing infrastructure and strengths of national QA programs. Its overall mission is to facilitate and support NCI sponsored advanced technology clinical trials, particularly those requiring digital data submission. This effort includes radiation therapy QA, image and radiation therapy digital data management, and clinical research and developmental efforts. Efforts are made to utilize each group's strengths and avoid duplication of existing programs. We strongly believe that advanced medical informatics can create an environment in which clinical investigators can receive, share, and analyze volumetric, multimodality treatment planning and verification digital data. Our vision is to promote the use of advanced medical informatics to facilitate digital data collection, information management, clinical trials QA review, and clinical trials education/training efforts, by providing an environment in which QA Centers can receive, share, and analyze volumetric multimodality imaging/treatment planning/verification (ITPV) digital data. Our ultimate goal is to improve the standards of care in the management of cancer by improving the quality of clinical trials medicine.

Specifically, we have identified eleven objectives (which can be grouped as coordination, service, and developmental efforts) as specified in the 2006 RFA for our ATC renewal application, which are listed below:

1. Eliminate duplication of infrastructure developmental efforts and facilitate sharing of QA resources among cooperative groups.
2. Help to insure that appropriate and uniform QA procedures and criteria for advanced technology trials are developed across all cooperative groups.
3. Facilitate/help manage the uniform credentialing of institutions for advanced radiotherapy trial protocols.
4. Facilitate/manage digital data protocol submission.
5. Facilitate/manage the QA review of submitted data.
6. Further the development of methods for rapid analysis of volumetric treatment planning data.
7. Assist clinical trial cooperative groups in the development of clinical trials protocols including: (a) credentialing requirements; (b) target volume definitions; (c) quality assurance procedures; and (d) data submission instructions.
8. Develop, implement, and maintain innovative methods for electronic exchange of digital planning data between institutions participating in clinical trials and between QA Centers.
9. Develop, implement, and maintain innovative web-based software tools to facilitate protocol digital data reviews by Study Chairs, Dosimetry Groups, the Radiological Physics Center (RPC), and the Quality Assurance Review Center (QARC).
10. Develop, implement, and maintain archival treatment planning and QA databases that can be linked with the cooperative groups? clinical outcomes databases.
11. Demonstrate understanding of and ability to achieve compatibility with existing software and electronic health record standards, including the Cancer Bioinformatics Grid (caBIG) and DICOM RT.

To accomplish these objectives, we propose to continue the ITC?s successful collaborations with the RTOG, RPC, and QARC which have pioneered the development of volumetric digital data submission, data archiving, and remote web-based QA review of clinical trials that utilize advanced technologies including, but not limited to, three-dimensional conformal radiation therapy (3DCRT), intensity modulated radiation therapy (IMRT), stereotactic radiosurgery and stereotactic body radiation therapy (SBRT), and brachytherapy. We have organized the ATC?s efforts around the following specific aims:

Specific Aim 1:

Maintain and manage (and make incremental improvements as required to) the current electronic data submission of advanced technology protocol credentialing and case data, archival storage, and remote QA review process utilizing ATC Method-1 (now referred to as the QuASA2R (Quality Assurance Submission, Archive, Analysis, and Review) system).

Specific Aim 2:

Develop novel web-based remote-review tools that will enhance the efficient and effective review of 3DCRT, IMRT, SBRT, and brachytherapy protocols. The tools and interfaces will be designed by a multidisciplinary team of experts in the quality assurance of clinical trials.? The design infrastructure of these tools will assist the development of future protocol processes such as image-guided radiation therapy (IGRT) and adaptive radiation therapy (ART).? The QuASA2R ?system will continue to be updated, and will remain modular in its design architecture to promote the efficient design, testing, and implementation of new tools and subsystems.? Starting from a DICOM-based ITPV data archive with well-defined interfaces, this approach will (a) allow the selective re-use and adaptation of existing QuASA2R system components, (b) enable the integration of a heterogeneous mix of commercial-off-the-shelf, open-source and custom software components; (c) facilitate testing and maintenance of system components, and (d) allow step-wise evolution/upgrading of the QuASA2R system to support technological advances in radiation therapy clinical trials.? Emphasis will be on the development and improvement of web-based remote-review tools that achieve compatibility with existing software and electronic health record standards, including the Cancer Bioinformatics Grid (caBIG) and DICOM RT, and maintaining/developing archival multimodality ITPV, credentialing, and QA databases for the advanced treatment modalities that can be linked with the cooperative group?s clinical outcomes database.

Specific Aim 3:

Assist cooperative groups in the development and management of advanced technology clinical trials protocols including (a) tumor/target volume and organ at risk definitions; (b) credentialing requirements and evaluation criteria; (c) electronic data submission requirements/instructions; and (d) quality assurance review procedures.

Specific Aim 4:

Serve as an educational resource to the nation?s clinical trial cooperative groups and participating institutions for support of advanced technology radiation therapy clinical trials.