Quality has become an important and elemental metric in modern clinical medicine. Senior leadership groups in modern hospital systems participate in daily reviews of processes and performance. Metrics for quality and safety are now in our daily inpatient and outpatient work scope and reported on a daily basis. Outcomes in oncology are increasingly measured by regulatory agencies and insurance providers for performance analysis. Processes in all aspects of medical care have been adjusted to ensure that quality and safety indicators remain a priority in the modern workplace. While this aspect of workplace behavior has accelerated in the past decade, the National Cancer Institute (NCI)-led trials including the current National Clinical Trial Network (NCTN) have had quality assurance (QA) for more than 5 decades. Changing clinical trial environments and modernization of therapy technology demand process improvements in the QA centers.1, 2, 3, 4, 5

In the mid-1960s, early pioneers in oncology practice saw the worth of being able to share information about patient management and outcome. Collaborative meetings were held in common venues to have conversations and create protocols that could be shared among institutions to evaluate and test clinical concepts in patient care management. Clinical trials established to test hypotheses of management and outcomes were reviewed periodically at biannual meetings. The process of trial development and outcome analysis became an important vehicle because trial outcomes would potentially influence standards of care. As clinical trial development broadened, it was recognized that an administrative structure would need to be established to generate clinical trials and simultaneously collect and collate information for study analysis. The NCI established a network for participation in what was called the cooperative groups now the NCTN. The cooperative groups became an extraordinary vehicle to develop management strategies and test the hypotheses in a national and international venue. Prior to 2014, there were 10 cooperative groups participating in all aspects of liquid and epithelial oncology.6 Many of the groups had strengths in most adult and pediatric disease disciplines and others had strengths in individual disease areas (Gynecologic Oncology Group [GOG]) and specific therapy disciplines (Radiation Therapy Oncology Group [RTOG]).

The NCI serves multiple purposes including supporting phase 1 activity when required and validating potential new advances in care through a phase 3 randomized approach. The groups were supported by individual group data/statistical centers and tissue banks. In 2014, the cooperative system was consolidated into 5 groups, 1 pediatric group, and 4 adult groups. The NCI consolidated all the QA review centers in imaging and radiation oncology into 1 group called the Imaging and Radiation Oncology Core (IROC). IROC includes the former Radiological Physics Center (RPC, IROC Houston), the Quality Assurance Review Center (QARC, IROC Rhode Island [RI]), The University of Ohio (IROC Ohio), and the core labs for the American College of Radiology Imaging Network (ACRIN) and RTOG, now IROC Philadelphia.1, 2, 3, 4, 5 The current schema is listed in Figure 1. Each IROC QA Center has individual strengths, and the consolidation has provided an opportunity to leverage these strengths to support imaging and radiation oncology core service functions for the NCTN. This provides an opportunity to harmonize protocol review for each group and align data management and acquisition pathways for translational research. As the pathways for data management become transparent, the data can be reformatted for upload to national archives including The Cancer Imaging Archive (TCIA) for secondary analyses research, and development in artificial intelligence (AI).7,8 If the trials are well designed and the data acquired are in standard formats, the data provide an extraordinary opportunity to not only support and validate primary clinical trial endpoints but also serve to be re-purposed for secondary analyses by site and study investigators. Upload to archives such as TCIA make the data available for analyses by scientists worldwide.

For confidence in the primary and secondary analyses, the data need to be adherent to trial guidelines and as uniform as possible so that the results of the analysis can be applied to the science of patient care. This is why QA of the clinical trial matters. In the next section, we will review the history of QA and how processes have matured over the past 5 decades.