TI, Clinical Image Evaluation CGT Training from Clinical Strategy...
Pharma Tech Outlook

TI, Clinical Image Evaluation CGT Training from Clinical Strategy Sharing to Practice

Pharma Tech Outlook | Tuesday, October 17, 2023

'Imaging endpoints in CGT clinical trials: strategy & practice' seminar held on the 5th
"Clinical design must be done after consultation with experts with essential imaging equipment experience"
"Performance performance needs to be monitored and managed along with training of institutions and evaluators"

On the 5th, TI and the National Clinical Trial Support Foundation held a seminar with the theme ''Imaging Endpoints for Cell/Gene Therapy in Clinical Trials: Strategy & Hands-on''. / Photo = Reporter Hwang Jae-seon

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TI (Trial Informatics), a clinical trial platform technology development and data management analysis company, successfully completed a practical seminar on cell gene therapy (CGT) clinical trial image evaluation methods held jointly with the National Clinical Trial Support Foundation on the 5th.

This seminar will be held under the theme of 'Imaging Endpoints for Cell/Gene Therapy in Clinical Trials: Strategy & Hands-on', including domestic pharmaceutical companies, CRCs (medical institutions), and CROs (CROs). It was conducted at the office of the National Clinical Trial Support Foundation in Seoul for officials from clinical trial consignment organizations. In addition to theory classes, a small group of 16 people participated to provide systematic practical training.

According to the organizers, this seminar was designed to explain essential items to be considered when conducting independent imaging review (BICR) in CGT clinical trials, which are continuously increasing in recent years. To this end, an expert who actually carries out independent video evaluation operations and two domestic and foreign evaluators appeared as speakers.

Lee Jeong-hyun, CEO of TI Image, a subsidiary of TI and an imaging CRO that performs the operation, management, and evaluation tasks required for clinical trial image analysis, said that he provides the background of CGT and the independent imaging required from the sponsor's perspective when designing clinical trials. We introduced elements to consider in evaluation operations.

CEO Lee Jeong-hyun said, "In the early-phase of clinical trials for CAR-T treatments, the most representative cell therapy, patient safety is the most important, so it is essential to take the necessary patient follow-up period and the images necessary to confirm safety." He emphasized, “In addition, tumor evaluation will be conducted to confirm efficacy, and at this time, it is necessary to select appropriate tumor evaluation standards and essential imaging modality by considering the ingredients, mechanism of action, and indications of the new drug.” .

Representative Lee continued, “In order to ensure that the regulatory agency accepts that both patient safety and efficacy can be confirmed, we recommend consulting with an independent imaging evaluation expert from both operational and medical aspects.” .

CEO Lee predicted that the global trend favoring independent video evaluation will continue to increase until 2030. In particular, the importance of 'Operational part' and 'Project & Data management' is expected to emerge, and CEO Lee explains that quality aspects must be considered in addition to the evaluation results.

Dr. Kohkan Shamsi, co-founder of 'RadMD', a global imaging CRO, was also invited as a non-face-to-face speaker at this seminar. Dr. Shamsi's topic was 'Strategy for imaging data quality and risk management in CGT Clinical Trials': △Various risk factors in independent imaging evaluation design that may occur during CGT clinical trials △Importance of imaging and image evaluation data quality that is directly related to evaluation results explained.

He said, "In order to obtain high-quality imaging data in CGT clinical trials, it is very important to plan an independent imaging evaluation design from an earlier stage than in other clinical trials." , regulatory agency, etc. must be planned,” he explained.

In addition, “When selecting an independent imaging evaluator, it is important to have experience with the essential imaging equipment to evaluate the indication, and if experts with this experience conduct independent imaging evaluations, measurement variability can be reduced and high quality can be guaranteed.” He emphasized, “For this, training and standardization of institutions and evaluators are essential, and at the same time, there is a need to continuously monitor and manage their performance.”

The final speaker, TI CEO Kim Kyung-won (Professor of Radiology, Asan Medical Center, Seoul), spoke on the topic of 'Practical tips for central imaging reading & Monitoring focusing on RECIST 1.1 & LUGANO' and discussed what is practically necessary from the evaluator's perspective when evaluating independent images in CGT clinical trials. Tips explained.

CEO Kim said, "Independent image evaluation itself is important, but independent reading monitoring is necessary to check 'whether the reading regulations were observed and evaluated accurately' and 'differences between readers', etc. For this, actual central review and technical review are required. “(Technical review) must include everyone,” he said. “In order to reduce the deviation of important reading results, it is necessary to establish a systematic education and training system.”

In particular, because changes in the disease progression date (PD date) can have a significant impact on drug efficacy evaluation, it was repeatedly emphasized that in addition to preventing deviations between readers, it is necessary to provide time to have clear evaluation standards through education.

CEO Gyeong-won Kim, who completed the practical training after the theory lecture, said, "Through this event, the design stages, essential elements of operation, and considerations for high-quality image data required for independent image evaluation work of CGT clinical trials were explained to stakeholders such as sponsors and CROs. “I hope it was conveyed well,” he said.

He added, "I think it has great significance as it was the first practical lecture in the field of imaging clinical evaluation. If the opportunity arises, I would like to further strengthen the practical training in the next seminar."
 

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