Article originally posted on The Clinical Trial Vanguard by Moe Alsumidaie on October 9, 2024
Article originally posted on The Clinical Trial Vanguard by Moe Alsumidaie on October 9, 2024
A recent panel podcast on The Imaging Accuracy Crisis in Clinical Trials brought to light critical issues and innovative solutions that are reshaping the landscape of clinical trials. Moderated by Dr. Gordon Harris, Co-Director of the Tumor Imaging Metrics Core at Dana-Farber/Harvard Cancer Center and Professor of Radiology at Harvard Medical School, the session highlighted the challenges of clinical trial imaging accuracy, staffing shortages, and solutions being implemented across institutions. Panelists included Hailey McDaniels (Executive Administrative Director at UCSD Moores Cancer Center), Dr. Arcadia Cruz (Associate Administrative Director for Quality Assurance and Research Compliance at UCSD Moores Cancer Center), Patrick Panlasigui (Senior Manager of Clinical Operations at UW Fred Hutch Cancer Center), Kira Pavlik (Associate Director of Clinical Trials Operations at Yale Cancer Center), Nick Buzinski (Radiology Liaison at Karmanos Cancer Institute), and Antoinette Wade (Clinical Research Leader at VCU Massey Cancer Center).
Together, they delved into the significant error rates in trial imaging, the critical role of the Yunu platform in addressing these issues, the impact on sponsors, the scrutiny of data audits, and the increasing need for cross-institution collaboration. This discussion, packed with industry insights and real-world solutions, is essential listening for sponsors aiming to optimize clinical trial efficiency. Below are the key takeaways from this must-hear session.
High Error Rates in Clinical Trial Imaging: A Widespread Challenge
One of the most pressing issues discussed during the panel was the alarming rate of errors in imaging assessments at major institutions. Studies from UC San Diego, the University of Washington, and Yale Cancer Center revealed error rates ranging from 25% to 50% in clinical trial imaging assessments. As Dr. Harris explained, the complexity of imaging protocols and the manual processes used at many sites often result in these high error rates. Harris remarked, “It’s impressive they got it right 50% of the time,” given the level of intricacy involved in correctly assessing trial imaging.
These error rates aren’t just theoretical—every mistake represents a potential delay or misstep in trial progression, causing significant issues for sponsors who depend on timely and accurate data to make decisions. Harris pointed out that these errors are particularly pronounced at comprehensive cancer centers, where the volume and complexity of trials continue to rise. Sites are increasingly pressured to deliver on trial imaging metrics, but the manual processes they rely on often result in avoidable errors.
For example, manual tracking of imaging assessments on Excel spreadsheets at three prominent cancer centers led to inefficiencies, miscommunication, and frequent mistakes. These complexities affected everything from tracking imaging requests to completing reads and ensuring compliance with trial protocols. As a result, coordinators and radiology teams spent inordinate amounts of time preparing for audits, rechecking imaging reads, and trying to align trial data with imaging protocols. These manual processes are slow, error-prone, and costly to sponsors who rely on accurate imaging data to keep trials moving forward.
The Yunu Platform: Reducing Error Rates to Less Than 2%
The introduction of Yunu’s cloud-based platform has been a game-changer in addressing these widespread errors. UCSD, a recent adopter of the platform, has seen its imaging error rates drop from 50% to under 2% after implementing Yunu. Hailey McDaniels, Executive Administrative Director at UCSD, shared how the platform revolutionized their imaging workflows. Before Yunu, imaging assessments were manually tracked, often leading to inefficiencies and human error. Coordinators had to juggle Excel spreadsheets to track when reads were requested, whether they were completed, and if they were invoiced. These manual processes were error-prone, time-consuming, and frustrating for the team, particularly given the ongoing staffing shortages.
With Yunu, many of these tasks have been automated. The platform streamlines workflows by managing requests, tracking completion, and guiding clinical trial imaging assessments to assure compliance to protocol-specific requirements, preventing errors. McDaniels explained how this automation has significantly reduced the burden on coordinators, allowing them to focus on other essential tasks. Importantly, Yunu’s automation ensures that clinical trial imaging assessments are completed promptly and accurately, which is particularly valuable in an environment where radiologists are overburdened and understaffed.
The ability to reduce error rates to less than 2% has profoundly impacted both site operations and sponsor confidence. As McDaniels emphasized, this improvement isn’t just about avoiding errors—it’s about ensuring that trials proceed efficiently, with accurate data, saving sponsors time and money.
The Role of Data Audits and FDA Scrutiny
Another crucial issue discussed during the panel was the increasingly rigorous scrutiny of trial data by the FDA. Imaging assessments are subject to detailed audits, and any discrepancies or errors can result in penalties or delays in regulatory approvals. Sponsors are particularly vulnerable here, as FDA findings can severely impact trial progression.
Kira Pavlik, Associate Director of Clinical Trials Operations at Yale Cancer Center, shared her experience with a recent FDA inspection. During the audit, the inspector spent a week meticulously examining every clinical trial imaging data point from every active trial. Thanks to Yunu’s comprehensive audit trail, Pavlik’s team was able to provide the necessary documentation quickly and without any findings. This level of transparency and data accuracy is essential for sponsors, as it ensures trial data complies with FDA standards.
The ability to track every action in the clinical trial imaging assessment workflow is a significant advantage of using Yunu. As Pavlik noted, the platform allows her team to demonstrate compliance easily, reducing the risk of audit failures. This is especially important given the FDA’s heightened scrutiny of trial data in recent years. The cost of non-compliance can be substantial, not only in terms of financial penalties but also in terms of lost time, as trials are delayed while issues are corrected.
Impact on Sponsors: Time and Cost Savings
One of the key takeaways for sponsors from this discussion is the direct impact of imaging errors on trial timelines and costs. High error rates force sponsors to re-evaluate imaging data, often leading to trial delays, censoring of patients inappropriately enrolled and treated then later removed, and associated additional costs. These inefficiencies compound as trials become more complex, with multiple sites and increasingly intricate clinical trial imaging criteria. By significantly reducing error rates, Yunu helps sponsors avoid costly re-reads, delays, and the associated financial burdens.
A recent article highlighted the financial implications of clinical trial imaging errors for sponsors. According to the article, sponsors often lose millions of dollars in unnecessary re-reads, censored patients, and trial delays due to inaccurate imaging data. By automating key aspects of the imaging workflow, Yunu eliminates many of these costs, allowing sponsors to reallocate those savings toward trial advancements and innovation, such as expanding patient recruitment, enhancing site training and relationships, and investing in additional technologies. McDaniels noted that before implementing the enhanced efficiency of Yunu, the radiology team at UCSD often struggled to keep up with the increasing volume of imaging assessments, further exacerbating trial delays.
In today’s competitive landscape, where clinical trials are more numerous and complex than ever before and staffing shortages and turnover abound, the ability to cut costs and save time is invaluable to both sites and sponsors. Harris, who also serves as Yunu’s Chief Science Officer, pointed out that streamlined efficiency has freed up staff time at Yunu sites, which has led to a 16% increase in enrollments after adopting Yunu, with some sites seeing up to a 24% increase in imaging assessment volumes. Without streamlined workflow, sites struggle to keep up with the rising demand for trials and imaging assessments, leading to bottlenecks impacting sponsors. With Yunu, these bottlenecks are significantly reduced, improving trial efficiency and reducing costs.
Cross-Institution Collaboration and Resource Sharing
One of the key takeaways for sponsors from this discussion is the direct impact of imaging errors on trial timelines and costs. High error rates force sponsors to re-evaluate imaging data, often leading to trial delays, censoring of patients inappropriately enrolled and treated then later removed, and associated additional costs. These inefficiencies compound as trials become more complex, with multiple sites and increasingly intricate clinical trial imaging criteria. By significantly reducing error rates, Yunu helps sponsors avoid costly re-reads, delays, and the associated financial burdens.
A recent article highlighted the financial implications of clinical trial imaging errors for sponsors. According to the article, sponsors often lose millions of dollars in unnecessary re-reads, censored patients, and trial delays due to inaccurate imaging data. By automating key aspects of the imaging workflow, Yunu eliminates many of these costs, allowing sponsors to reallocate those savings toward trial advancements and innovation, such as expanding patient recruitment, enhancing site training and relationships, and investing in additional technologies. McDaniels noted that before implementing the enhanced efficiency of Yunu, the radiology team at UCSD often struggled to keep up with the increasing volume of imaging assessments, further exacerbating trial delays.
In today’s competitive landscape, where clinical trials are more numerous and complex than ever before and staffing shortages and turnover abound, the ability to cut costs and save time is invaluable to both sites and sponsors. Harris, who also serves as Yunu’s Chief Science Officer, pointed out that streamlined efficiency has freed up staff time at Yunu sites, which has led to a 16% increase in enrollments after adopting Yunu, with some sites seeing up to a 24% increase in imaging assessment volumes. Without streamlined workflow, sites struggle to keep up with the rising demand for trials and imaging assessments, leading to bottlenecks impacting sponsors. With Yunu, these bottlenecks are significantly reduced, improving trial efficiency and reducing costs.
Cross-Institution Collaboration and Resource Sharing
The panel also highlighted the importance of cross-institution collaboration in clinical trials, especially in the context of imaging assessments. With staffing shortages becoming a persistent issue, many institutions struggle to complete timely imaging reads. Jeff Sorenson, CEO of Yunu, who was in the audience for the session, explained how the platform enables institutions to share resources, allowing radiologists at one site or reading group to handle reads for another site. This collaborative approach helps alleviate the burden on individual institutions and ensures that imaging assessments are completed efficiently.
For example, institutions like UW, DF/HCC, St. Jude Children’s, and VCU have leveraged Yunu’s platform to outsource imaging reads to collaborating imaging cores at other participating sites, either entirely or during periods of short-staffing need. This helps smaller or overburdened sites manage their workloads and ensures that imaging assessments are conducted consistently across all trial sites. Sorenson noted that this feature has become particularly valuable as trial complexity increases and institutions struggle to meet demand.
Outsourcing imaging reads and collaborating across institutions is especially beneficial for sponsors, who need consistent and reliable data across all trial sites. By fostering cross-site collaboration, Yunu ensures trial protocols are implemented consistently across participating sites and trial timelines remain on schedule. This level of collaboration is key to managing the increasing complexity of modern clinical trials.
The panel also highlighted the importance of cross-institution collaboration in clinical trials, especially in the context of imaging assessments. With staffing shortages becoming a persistent issue, many institutions struggle to complete timely imaging reads. Jeff Sorenson, CEO of Yunu, who was in the audience for the session, explained how the platform enables institutions to share resources, allowing radiologists at one site or reading group to handle reads for another site. This collaborative approach helps alleviate the burden on individual institutions and ensures that imaging assessments are completed efficiently.
For example, institutions like UW, DF/HCC, St. Jude Children’s, and VCU have leveraged Yunu’s platform to outsource imaging reads to collaborating imaging cores at other participating sites, either entirely or during periods of short-staffing need. This helps smaller or overburdened sites manage their workloads and ensures that imaging assessments are conducted consistently across all trial sites. Sorenson noted that this feature has become particularly valuable as trial complexity increases and institutions struggle to meet demand.
Outsourcing imaging reads and collaborating across institutions is especially beneficial for sponsors, who need consistent and reliable data across all trial sites. By fostering cross-site collaboration, Yunu ensures trial protocols are implemented consistently across participating sites and trial timelines remain on schedule. This level of collaboration is key to managing the increasing complexity of modern clinical trials.
Addressing Sponsor Needs
A key moment in the discussion came when Dan Otap from Genentech, who was attending the session, raised concerns about the complexity of imaging protocols and how they are managed across multiple trial sites. Otap emphasized the importance of clear and consistent guidelines for imaging assessments, particularly when multiple sites are involved. Jeff Sorenson explained how Yunu’s platform standardizes imaging protocols across sites, ensuring consistency and accuracy.
Sorenson elaborated that Yunu allows sponsors to set up a trial once and project it across all participating sites. This standardization is critical for sponsors, ensuring that clinical trial imaging assessments are conducted uniformly, regardless of the location – something that Yunu found is rarely happening. Additionally, the platform manages data de-identification and provides real-time access for site monitors, allowing sponsors to oversee the trial process easily.
This exchange underscores Yunu’s ability to meet sponsor-specific needs, particularly in managing complex imaging protocols and multi-site trial harmonization. By ensuring all trial sites adhere to the same standards, Yunu helps sponsors maintain control over trial data, improving accuracy and efficiency.
Summary
A key moment in the discussion came when Dan Otap from Genentech, who was attending the session, raised concerns about the complexity of imaging protocols and how they are managed across multiple trial sites. Otap emphasized the importance of clear and consistent guidelines for imaging assessments, particularly when multiple sites are involved. Jeff Sorenson explained how Yunu’s platform standardizes imaging protocols across sites, ensuring consistency and accuracy.
Sorenson elaborated that Yunu allows sponsors to set up a trial once and project it across all participating sites. This standardization is critical for sponsors, ensuring that clinical trial imaging assessments are conducted uniformly, regardless of the location – something that Yunu found is rarely happening. Additionally, the platform manages data de-identification and provides real-time access for site monitors, allowing sponsors to oversee the trial process easily.
This exchange underscores Yunu’s ability to meet sponsor-specific needs, particularly in managing complex imaging protocols and multi-site trial harmonization. By ensuring all trial sites adhere to the same standards, Yunu helps sponsors maintain control over trial data, improving accuracy and efficiency.
Summary
The panel discussion highlighted the critical role that platforms like Yunu play in addressing the accuracy crisis in clinical trial imaging. With error rates of 25% to 50% at even top-tier institutions, the need for automated solutions has never been greater. Yunu’s ability to reduce error rates to less than 2%, streamline workflows, and enable cross-institution collaboration makes it an indispensable tool for sponsors looking to optimize trial efficiency.
For sponsors, the benefits of Yunu are clear: reduced costs, faster trial progression, and greater confidence in the accuracy of trial data. The platform’s ability to meet stringent FDA requirements and facilitate resource sharing across institutions further enhances its value. As the complexity and volume of clinical trials continue to grow, Yunu will be essential in ensuring that trials remain accurate, efficient, and compliant.
The panel discussion highlighted the critical role that platforms like Yunu play in addressing the accuracy crisis in clinical trial imaging. With error rates of 25% to 50% at even top-tier institutions, the need for automated solutions has never been greater. Yunu’s ability to reduce error rates to less than 2%, streamline workflows, and enable cross-institution collaboration makes it an indispensable tool for sponsors looking to optimize trial efficiency.
For sponsors, the benefits of Yunu are clear: reduced costs, faster trial progression, and greater confidence in the accuracy of trial data. The platform’s ability to meet stringent FDA requirements and facilitate resource sharing across institutions further enhances its value. As the complexity and volume of clinical trials continue to grow, Yunu will be essential in ensuring that trials remain accurate, efficient, and compliant.
This article is sponsored by Yunu.
