Michael O\u2019Neal<\/strong>, M.D.<\/strong> – Chief Medical Officer, Imaging at Clario<\/p>\n\n\n\n The quality of medical imaging in oncology clinical trials can make or break the success of your new therapy. Imaging is performed on an ongoing basis while patients receive therapy to evaluate their response to treatment and is the primary endpoint to evaluate drug efficacy in clinical trials. If medical images are missing, or scans are not of consistently high quality, you risk overlooking critical insights which can affect your oncology drug\u2019s approval progress. Now more than ever, biotechnology companies are trying to leverage an expedited regulatory pathway when possible, making data consistent, reconciled, and clean is important to the efficiency and success of the study. Since this data is so crucial to oncology trials, shouldn\u2019t we ensure that the image collection data is correct on an ongoing basis rather than only a few times during a study? <\/p>\n\n\n\n Image scan collection in particular is a very important component of oncology trials, and reconciling this information proactively can prove to be very valuable. Ensuring this information is consistent and accurate between the sponsor and the imaging vendor is crucial. <\/p>\n\n\n\n During the course of a study, image scan collection information is usually captured in the sponsor\u2019s Interactive Voice Response (IVRS) or EDC system. Image scan collection information is stored at the imaging vendor using the designated image repository software. Sponsors also provide an enrollment report or a scan listing to ensure that the vendor is up to date with the information of all subjects that are participating in a trial.<\/p>\n\n\n\n This data collected at the vendor is solely based on the protocol-required imaging scans that are being submitted from the site. Looking at an IVRS or EDC system may not tell you if the images were received at the imaging vendor. At times, the vendor does not have all the scans the Sponsor needs. This can be due to many reasons:<\/p>\n\n\n\n Therefore, to ensure all necessary scans are captured, it is essential that on a routine basis (preferably monthly), the imaging scans are proactively reconciled with the sponsor\u2019s electronic system against the imaging vendor\u2019s image repository system. Periodically reviewing this data can be more efficient and help reduce errors. It can also better allow the sponsor to promptly identify gaps and follow up with sites that are not submitting scans for the vendor to review.<\/p>\n\n\n\n By implementing an effective \u201cmissing\u201d versus \u201cexpected\u201d reconciliation plan, you\u2019ll allow for a more seamless review of the imaging scans. You can also eliminate any unnecessary work for sites, CRO, and EDC vendors. This process ensures that imaging data is intact, and no further follow-up is required, resulting in clean and complete imaging data set. By performing this reconciliation activity, vendors are better able to proactively identify any missing, discrepant, or unscheduled imaging scans that need site follow-up in a timely manner. Not performing this activity on a routine basis can affect essential deliverables such as interim analysis, ad-hoc transfers, and database locks. To make the reconciliation activity a seamless one, there are a number of tools and technologies that can be used to improve the accuracy and efficiency of image reconciliation. These tools include:<\/p>\n\n\n\n The addition of these tools and technologies can help to improve the accuracy and efficiency of oncology image reconciliation to ultimately lead to better outcomes for patients impacted with cancer.<\/p>\n\n\n\n Our team of experts are ready for your questions about your next oncology clinical trial. To contact us, email science@clario.com<\/a>.<\/p>\n\n\n\n From electronic image transfer to independent analysis, Clario offers a fully integrated, end-to-end solution. Our clinical imaging solution is data-privacy compliant and enables easy electronic image submission, all with a fully integrated, efficient, and streamlined process. Fusing our deep scientific expertise and global scale into the broadest endpoint technology platform, we empower our partners to improve patient care.<\/p>\n\n\n Learn more about how Clario\u2019s Medical Imaging expedites oncology drug development<\/p>\n\n\n\nThe reconciliation processes<\/h2>\n\n\n\n
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Best practices for image reconciliation<\/h2>\n\n\n\n
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Learn more<\/h3>\n\n\n\n