Improving start-up times in oncology clinical trials: An ASCO quality improvement project.

Abstract

297 Background: With the increasing complexity of clinical trials, the UNMCCC and NMCCA are seeing increased delays in study activation. Currently, the average time from protocol receipt to trial activation is 33 weeks. Creating strategies to shorten the timeline where the longest delays occur will expedite patient access to novel therapies and improve patient care. Aims: Define the average activation timelines; Identify the timeline where an intervention will make the most impact in shortening start-up time; Implement an intervention, beginning February 2018; Identify strategies to decrease the longest timeline by 50% by December 2018. Methods: Timelines of 81 clinical trials opened in 2017 were analyzed. Data showed that the longest timeline is IRB approval to activation (12 weeks) and identified this as the focus of intervention to decrease our overall activation time by 50% (6 weeks). Two focus group meetings with involved staff were organized and completed. Interventions were identified. The time to complete activation tasks cannot be shortened due to staffing resources. However, shifting these tasks forward in our timeline could decrease the time to activation by at least 6 weeks. A sponsor survey was created to identify logistical concerns earlier. Regulatory coordinators were provided an email template to request systems access early. Site initiation visits are scheduled earlier. Results: Our data shows that our interventions have had a strong positive impact on our timelines. Conclusions: Since implementation, we have seen an improvement in our study timeline. We will continue to track and analyze our timeline data to determine if these strategies are effective across trials with varying startup complexities.[Table: see text]

Streamlining and Cycle Time Reduction of the Start-up Phase of Clinical Trials

“…This resulted due to deferral in the PCLM and IDS pharmacy approvals (Figure 1). Therefore, in the original start-up phase, approvals from IDS pharmacy and PCLM must be in 7 place before the study package is submitted to IRB. This would help the trial to be on track and prevent any obvious scope of delay for subject recruitment.…”

“…On a whole, the start-up phase represents a significant and logistical undertaking [6]. However, duration of the start-up phase generally varies among sites and depends on trial complexity [6,7]. FOCUS-PDCA is an effective method to systematically solve a simple/complex clinical process problem.…”

Streamlining and cycle time reduction of the startup phase of clinical trials

“…Overall, the startup phase constitutes an administrative and logistical undertaking [6]. However, the duration of the startup phase generally varies among sites and depends on trial complexity [6,7].…”