An international comparison of barriers in opening oncology clinical trials

Abstract

6580 Background: Well designed clinical trials are critical to improve the outcomes of patients with cancer. There are significant barriers to accrue patients to clinical trials beginning with processes required to “open” a trial. This study aims to compare the procedures and time required to open thoracic oncology trials at a United States academic center to a similar center in Europe. Methods: A retrospective review was performed of all thoracic oncology therapeutic trials submitted for regulatory review between 2001–2008 at Washington University School of Medicine (WUSM) and the University of Torino, Italy (UT). A process map was drafted by both institutions to establish the order of required events. The timing data for each step was collected and analyzed for comparison. Results: A total of 137 therapeutic thoracic oncology trials were reviewed, 83 from WUSM and 54 from UT. Five major regulatory steps are required to open a trial in WUSM compared to three at UT. The median times to open a trial are 163 days (with inter-quartile range of 91 to 257 days) for WUSM and 122 days for UT (with inter-quartile range of 96 to 159 days) (p = 0.048). The median times for regulatory approval are 75 days (inter-quartile range, 26 to 131 days) for WUSC and 31 days (inter-quartile range, 10 to 67 days) for UT (p<0.0001), attributed to the additional requirement of Scientific Review Committee approval at WUSM prior to consideration by the Institutional Review Board (IRB), while regulatory approval is a single process at UT. However, the median time for contact approval process identified as the limiting step requiring a median of 115.1 (WUSM, inter-quartile range of 78 to 187) or 84 (UT, inter-quartile range of 44 to 124) days (p = 0.011). Conclusions: It takes additional steps and significantly longer time to open a therapeutic thoracic clinical trial at a representative U.S. site (WUSM) compared with a site in Europe (UT). As global trial collaboration increases, uniform strategies must be developed to shorten the administrative process, encouraging the creation of streamlined systems that enable centers to increase the number of agents under investigation. No significant financial relationships to disclose.