The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has issued the “Guiding Principles for Benefit and Risk Assessment Based on Multi-regional Clinical Trial Data in Global Synchronous Development of New Drugs (draft proposal)” and is soliciting public feedback for a period of two months.
Consistency in Multi-regional Clinical Trials (MRCTs)
For multi-regional clinical trials, the draft proposal emphasizes the importance of fully demonstrating the consistency of internal and external factors between regions in the trial design. Known or potential differences should be considered in the design and statistical analysis, such as subgroup stratification, and evaluated based on the trial results.
Recommendations for Global Synchronous R&D
Ideally, during the process of global synchronous research and development, it is recommended that early clinical research in China be initiated as soon as possible. This allows for gathering extensive knowledge about the pharmacokinetics (PK), dose exposure effect relationship, and other necessary information specific to the Chinese population before participating in confirmatory MRCTs. A comprehensive assessment of potential internal and/or external factor differences between the Chinese population and other regions, in combination with drug characteristics, will enable the design of scientifically sound and reasonable confirmatory MRCTs. This approach will support consistency assessment and benefit-risk assessment for Chinese patients. Information on other drugs with the same mechanism of action can also aid in supporting the above evaluation.
Communication with Review Agencies
If a sponsor plans to make a clinical filing in China with data from overseas trials, it is encouraged to communicate with the review agency during the development of the clinical trial plan. Key issues related to the overall research strategy and trial design should be discussed, and consensus should be reached on the scientific questions answered by the corresponding clinical trials and the adequacy of the data generated, such as trial endpoints, success criteria, and regional sample sizes.-Fineline Info & Tech
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