This application is in response to Notice NOT-CA-13-011, which is a clarification of the specific requirements and aspects of the scientific scope of PAR-11-150 Quantitative Imaging for Evaluation of Responses to Cancer Therapies (U01), This Notice states ... the specific purpose of this Notice is to add an opportunity for applicatios to be focused only on supporting QIN network-wide research resources. In 14 years of service to the national undertaking of curing cancer, the American College of Radiology Imaging Network (ACRIN) has conducted many prospective clinical trials to evaluate imaging's role in defining therapeutic response and in the prognostic and diagnostic evaluation of disease. As a QIN U01Center, the ECOG-ACRIN QIN Resource will also leverage ECOG-ACRIN's clinical trial development structure (Aim 3) to enable prospective testing for methods developed by the QIN. The overall objective of the proposal is efficient and effective clinical research at reasonable cost. The proposed ECOG-ACRIN QIN Resource will achieve that goal by enabling QIN investigators to apply novel QIN methods to appropriate clinical trials. As part of the QIN, the proposed ECOG-ACRIN QIN Resource will act as a scientific site for evaluating methodologies and metrics for quality assurance of imaging and associated data, focusing on understanding the costs of efficient and effective site qualifications that result in high-quality imaging studie and the metrics required to appropriately define the number of participants required for adequate analysis. This project will evaluate quality control at QIN laboratories, comparing practices currently applied by the NCI (e.g., CQIE) and ACR Imaging Core Laboratory (Aim 1) at each participating QIN site. The ECOG-ACRIN QIN Resource will further act as a resource development platform (Aims 2 and 3). ECOG-ACRIN, in league with the Brown Statistical Center, proposes to develop datasets for method testing and validation from completed ACRIN research for assessment of QIN metrics and validation purposes (Aim 2). In the Resource, outcomes and progression data will be made available for correlation with computational findings. Finally, the ECOG-ACRIN QIN Resource will bring expertise across QIN Working Group platforms-in PET, MRI, CT, imaging statistical design, and informatics-to clinical trials by integrating quality assurance and QIN quantitative tools into prospective National Clinical Trial Network research (Aim 3). The ECOG-ACRIN QIN Resource PIs stand at the frontlines within the ECOG-ACRIN clinical trials development structure as leaders of the Experimental Imaging Science Committee (EISC) and Biomarker Group and Imaging Science Advisory Committees (ISAC), which review imaging studies prior to submission to NCI for consideration, and thus open the door to identifying appropriate opportunities for prospective evaluation of QIN laboratory projects (Aim 3).
The evolution in our understanding of cancer requires an evolution in the design and implementation of clinical trials, and the quantitative imaging used to assess therapeutic efficacy. This was noted in the Institute of Medicine's influential report A National Cancer Clinical Trials System for the 21st Century, which stated that 'the current structure and processes of the entire clinical trials system need to be redesigned to improve value by reducing redundancy and improving the effectiveness and efficiency of trials'. The goal of this study is to accelerate the development and deployment of quantitative imaging methods that improve the effectiveness and efficiency of clinical trials by using the combined resources of the American College of Radiology (ACR), the NCI-sponsored cooperative group ECOG-ACRIN (E-A), and the NCI Quantitative Imaging Network (QIN). To achieve this goal, and in accord with NOT-CA-13-011, this proposal is focused on supporting QIN network- wide research resources.
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