Application and Regulatory Challenges of Artificial Intelligence/Machine Learning in Clinical Trials:An Analysis Based on FDA Discussion Papers,EMA Reflection Papers,and Stakeholders'Comments
Drug development must comply with relevant regulatory requirements,guided by industry guidelines developed by regulatory agencies,with reference to relevant use cases.The approval of new drugs must be based on evidence generated from clinical trials.With the continuous development of biopharmaceutical industry,the complexity of clinical trials has increased.Merely increasing investment is insufficient for improving clinical trial efficiency and addressing issues of low pipeline productivity and soaring costs.This paper explores the application and regulatory challenges of artificial intelligence/machine learning(AI/ML)in clinical trials by analyzing content from FDA discussion papers,EMA reflection papers,and stakeholders'comments.
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