Background & Objective

The time from conception to the initiation of clinical trials has been described as costly and time-consuming because of administrative processes (Martinez, D. A. et al). The long clinical trial activation period results in delay in data and affects evidenced-based medical practice. Long clinical trial activation times may be associated with a variety of factors. The objective of this research is to identify and assess factors that impact clinical trials activation periods at the University of Illinois Cancer Center Oncology Clinical Trials Office (UICC OCTO). Methods A protocol search for UICC OCTO managed studies was generated in OnCore. The search was limited to trials that were activated from January 1st, 2016 through November 30, 2017. Time to activation was defined as the time of protocol submission to the Protocol Review Committee (PRC) to the time the study was opened to accrual. Studies which were PRC approved in 2016 but attained Open to Accrual status in 2017 was counted as part of 2016 studies. Time to activation differences between 2016 and 2017 studies was assessed by IIT, Sponsor Type, Institutional Review Board (IRB) Review Type and Study Type. Results A sample of 22 studies (Calendar Year 2016, 12; Calendar Year 2017, 10) was identified. The average activation time was 206.8 days for calendar year 2016 and 78.2 days for calendar year 2017. Results indicate that the activation time generally decreased in 2017 regardless of Sponsor Type, IRB Review Type or Study Type but not whether the study was interventional or not. The average time to activation for interventional studies decreased in 2017 but remained similar for non-interventional studies. Notably, average activation time was longer for non -IIT and Industry studies for both years. Conclusions Clinical trial activation times at the UICC OCTO decreased from 2016 to 2017. The mix of study Sponsor Type, IRB Review Type or Study Type between the two years was similar, and the decrease between the years appears to be independent of these variables. Therefore, it can be inferred that the decrease in activation time was due to interventions made to the process between the two years. These interventions included increase in staff, reorganization in staff duties including moving all activation oversight activities to a new start-up coordinator position, and process changes implemented to increase efficiency. These results should take into consideration that 50 % of studies submitted to the PRC in 2017 will roll over into 2018 for activation, and are therefore not included in the 2017 sample. The data will be reanalyzed at a later time to capture the activation time for all studies started in 2017. In addition, activation time will continue to be tracked to see the effects of additional process changes.

Citation Format: Mary A. Otoo, Michelle Uriostigue Preza, Margaret Gavor, Darlene Kitterman, Oana Danciu. An analysis of factors associated with oncology clinical trial activation at University of Illinois Cancer Center Oncology Clinical Trials Office [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 4764.