Oncology clinical trials require reliable imaging data management, however recurring nonconformity issues are commonly reported. Radiological workload is increasing, which reduces radiologist’s availability and potentially affects diagnostics quality. In this study, we compared performances of an institutional standard radiological workflow (SW) and a novel “hybrid workflow” (HW).
We prospectively studied imaging data of 40 patients included in a RECIST 1.1 clinical trial (Apr-Dec, 2017) at Centre Antoine Lacassagne (CAL), Nice, France. 97 time-points were reviewed by 7 radiologists and one trained technologist. Nonconformities using the SW were retrieved from CALs’ 2015 archives. SW involved radiologists who used the Advantage Workstation platform without electronic reporting system (General Electric, USA). For the HW, radiologists performed all baseline evaluations and the technologist did the subsequent generic measures on follow ups. Radiologists then checked the technologist’s findings, before confirming the evaluations. The HW used LMS (Median Technologies, France) featuring an electronic reporting system. An independent body compared SW and HW reading time and nonconformity occurrences.
Using SW, 19 types of nonconformities were found: blank report (13%); unsigned report (11%); undocumented change of tumor burden (10%); undocumented new lesions (9%); missing/wrong patients’ visit date (7%); undocumented tumors location (5%); error in tumor burden change (5%). SW and HW nonconformities affected 55% (179/323) and 5% (2/40) of reports respectively (p < 0.001). HW nonconformities were: one wrong login name entered in the LMS platform and one erroneous time point numbering. SW required, on average, 11’30” [10’06”; 13’20”] to perform the radiological analysis per timepoint. HW required 1’35” [40”; 5’08”] for radiologists, and 12’18” [11’12”; 14’18”] for the technologist.
HW significantly reduced the number of trial nonconformities and saved 87% of radiologists’ time while keeping their expertise in the final decisions. HW could represent an efficient cost reduction opportunity associated with imaging trial quality improvements.
Clinical trial identification
Legal entity responsible for the study
Antoine Lacassagne Anticancer Center.
Has not received any funding.
H. Beaumont, C. Klifa: Employee: Median Technologies. All other authors have declared no conflicts of interest.