歐洲藥品局

2023年5月17日

教育津貼為人工智能優化臨床試驗提供了支持。兩個Owkin AI模型為總體存活率顯著提高精度的歧視在肝細胞癌和間皮瘤。Owkin發展按需預後評分為其他跡象進一步減少臨床試驗失敗率巴黎,法國,5月17日2023 - (ACN通訊社)——人工智能生物技術Owkin AI-powered解決方案的領先供應商的藥物發現和臨床發展,收到了一封來自歐洲藥品局的支持(EMA)對他們提出的統計調整深度學習協變量預後獲得組織學幻燈片。該方法使用兩個深度學習模型的預測,MesoNet和HCCnet預後的生物標誌物調整總生存期的延長生命的藥物療效分析隨機第二階段和第三階段的臨床試驗。EMA支持人工智能優化臨床試驗MesoNet和HCCnet是專有的深度學習模型訓練使用數字化病理成像間皮瘤和肝細胞癌(HCC)患者預測總體存活率。執行培訓使用pre-trained模型的算法從圖像中提取信息,關注小區域的活檢最相關的預測。模型帶來了顯著改善預後的性能對整體生存時添加到當前使用分層的因素。擬議中的上下文使用應用深度學習模型的預測預後的生物標誌物調整總生存期的延長生命的藥物療效分析隨機2/3期臨床試驗。MesoNet預測將用於調整總生存期的延長生命的藥物療效分析一線惡性胸膜間皮瘤患者隨機2/3期臨床試驗。HCCnet預測將被用來調節功效分析總生存期的延長生命的藥物輔助設置切除肝癌患者隨機2/3期臨床試驗。 The EMA recognizes that the proposed AI models' main proposed strength is the gain in prognostic performance compared to current practice's covariate adjustment in clinical trial settings. The models' interpretability features allow researchers to understand the salient features that informed the model's prediction and avoid the drawbacks of black box AI models. However, the evidence base for the AI model approach as new technology is limited compared to traditional approaches. Therefore, Owkin is encouraged to use their approach in future trials and do additional prospective validation. Felix Balazard, Director of Optimized Development at Owkin said: "This EMA letter of support offers a clear regulatory path for integrating AI models based on histopathology into the analysis of randomized clinical trials. Owkin is bringing AI to the regulatory setting." Covariate adjustment has been endorsed by regulatory agencies like the EMA and FDA, and Owkin believes that its data-driven approach to this statistical method can significantly improve the success rates of trials, including the ongoing mesothelioma and HCC trials. With Owkin's Federated Research Network, it can develop on-demand prognostic scores for other indications, which can further reduce clinical trial failure rates. Contact Information