ICON’s large pharmaceutical sponsor required an ‘Accelerated Imaging Data Delivery for Regulatory Submission’ on a phase 3 advanced and/or unresectable biliary tract carcinoma study that spanned 277 sites with 1,115 patients. ICON was notified of the accelerated 10-day turnaround time for image data delivery in November with an anticipated Last Patient Last Visit (LPLV) date of 15 December, which afforded much less than the standard 12-week lead time for appropriate preparation. ICON’s medical imaging team and the sponsor had to collaborate to successfully abbreviate their accelerated turnaround procedures over a holiday period and maintain quality to deliver the complete data ahead of the database lock.

ICON’s medical imaging team had to collect, read, assess and quality control (QC) a vast number of medical imaging scans in a very short window. ICON also had to ensure reader availability for the high volume of work during a holiday period when many individuals take time off work.

There were 104 missing scans, 20 countries with open queries for missing scans and a large number of future scans expected close to LPLV which increased the risk for scans to be excluded from the data transfer. There were also an unknown number of unscheduled scans that had to be identified and reconciled within the data. ICON’s medical imaging office was also relocating during this time, on 17 December. This posed potential risks for imaging received via courier as there was Core Lab disruption during this time which could delay image QC and independent review.

The first priority was to address the large number of queries for missing scans. In addition to the reminders included in the SQUARE platform, ICON’s standard query resolution process, personal reminder emails were sent to each site with open queries. The sponsor committed CRA intervention with sites to ensure all missing scans were submitted by 23 November to ensure readers had adequate time to complete their radiological blinded independent assessments and for post-read quality control to be conducted.

To ensure expected scans arrived in a timely manner, ICON updated the system to automatically raise queries the day after scans were expected, and the sponsor backed this 24-hour goal with CRA support to ensure a steady flow of imaging through the process. ICON and the sponsor also met twice weekly for real-time data reconciliation and to cross reference with the EDC to identify data mismatches and unscheduled or missing scans to ensuring none would slip through the cracks. These meetings also facilitated ongoing risk assessments, including mitigation of COVID-19 impacts.

ICON sent bi-weekly transfers leading up to the milestone transfer for proactive data management activities and planned to accommodate up to five late scans no later than 20 December to ensure turnaround times were achieved with quality.

To address reader availability the ICON team had to commit to working over the holiday period and two additional readers were trained and ready in case technical or other issues prevented another reader completing work. ICON ensured provision of IT support during the holidays for any unforeseen technical issues to mitigate risks to the accelerated timeline.

The milestone transfer was delivered on time with all expected scans accounted for and the regulatory database lock was achieved. This study has had much success after this interim analysis database lock and the drug has ultimately been approved by the FDA. ICON provided the expertise and resources to carry out the robust tasks and processes required to collect and QC imaging scans and their corresponding data, facilitate independent radiologist reads and post-read QC, and for statistical analysis and submission. These capabilities greatly contributed to this success as imaging was the primary study endpoint. ICON’s effort, collaboration and agility to deliver under extenuating circumstances provided the quality data the sponsor needed.

The solutions and processes leveraged in this accelerated case are now standardised, so that all ICON medical imaging studies strive to be prepared to deliver an interim analysis at all times.

Contact us to learn more about how ICON can seamlessly deliver your clinical trial imaging data. Please visit ICONplc.com/contact for more information.