Editorial: Importance of quality assurance in radiation oncology clinical trials

For process improvements to occur in oncology clinical medicine, well-constructed clinical trials 14 have become a standard component in patient care. To demonstrate improvements in tumor control 15 and assessment of the impact of therapy on normal tissue function, clinical trials have become the 16 most respected vehicle for the evolution of adjustments and improvements in clinical management. 17There are challenges to developing and executing clinical trials. To be successful, trials must ask 18 relevant questions and be constructed in a manner that the trial questions can be managed and 19 answered in a cooperative multi-institutional/site setting. Most trials require multiple diverse 20 institutions to actively participate in the trial to meet accrual goals for statistical relevance. Therefore, credentialing can be specific for a clinical trial, however QA centers work to minimize 56 duplication of effort to ensure feasibility of trial accrual and limit burden on site investigators. 57 Data acquisition and data management are evolving into essential components of trials. As clinical 58 trials become more complex with response adaptive components including multiple points of 59 randomization within a single trial, acquiring the correct information at the correct time point is 60 important to ensure data can be reviewed in real time to respond to the specific trial objectives. For 61 example, case review for modern Wilms tumor studies is important. In stage 4 patients with 62 pulmonary involvement at presentation, thoracic RT is not delivered if the patient has a complete 63 response to chemotherapy. The cases are reviewed by a limited number of trial radiologists in real 64 time providing uniformity in interpretation. However, the data are received continuously, often in 65 diverse formats which must be processed and collated in a uniform manner for this review. The work 66 is ongoing and dynamic with interactions between site and trial investigators. These processes 67 continue to mature with increased complexity of modern clinical trials. 68 Clinical trials require the acquisition of a significant amount of data including medical history, 69 laboratory data, pathology, biomarkers, imaging, RT treatment objects, systemic therapy, and 70 molecular biology. These components play an important role in patient outcome and outcome 71 analysis. One essential objective of QA is to affirm the data is accurate and managed in a compliant 72 manner. These data should be managed so that the information can be re-purposed for additional 73 study and review by independent investigators and audit teams. Because patients are treated in a 74 uniform format and the objects are acquired in a comprehensive trial-compliant manner, the data 75 becomes an ideal resource for the development of platforms for artificial intelligence and secondary 76 research for questions not anticipated at the time of trial design. 77The work touches on all topics presented in this research portfolio. Accurate and complete datasets 78 provide confidence we can trust the outcome of a oncology clinical trial (1-6). 79