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MRCT Center holds Regulatory and Scientific Workshop at Peking University

News_11-3-15

The MRCT Center and Peking University collaborated to develop a framework, harmonized to guidance from ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), regarding how countries can consider the importance of ethnic factors, trend consistency and the definition of region in the evaluation on drug efficacy and safety for the design of multi-regional clinical trials.

The MRCT Center and Peking University collaborated to develop a framework, harmonized to guidance from ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), regarding how countries can consider the importance of ethnic factors, trend consistency and the definition of region in the evaluation on drug efficacy and safety for the design of multi-regional clinical trials.

A workshop at Peking University on 26 October 2015 convened 50 academic leaders, regulatory officials including CFDA, the PMDA, US FDA, and academic and industry leaders in a small, invitation-only closed meeting. Phase one of our project team efforts was presented to the global regulators, focusing on the scientific principals underlying global regulatory decision-making for multi-regional clinical trials.

Key presentations included:

  • Bob O’Neill (US FDA) History and rationale for ICH E-5 – Dr. O’Neill set the stage for how bridging may be achieved from extrapolation to utilization of data from one region to another.
  • Leigh Verbois (Director US FDA China Office) – Dr. Verbois discussed how strong regulatory systems may be effectively driven through collaboration and key learning opportunities such as this workshop. She praised the Center of Excellence concept that is being launched in Asia for training of regulators as one that will effectively build capacity in the region.
  • Workgroup 1 (Chen Gang, Johnson & Johnson; Tony Guo, Merck; Barbara Bierer, Rebecca Li, MRCT Center) – Proposed a new model for how consistency may be defined. This model contemplates 3 levels of consistency based on disease category.
  • Workgroup 2 (Luyuan Dai, Boehringer Ingelheim; Yangfeng Wu, Peking University; Pei Hu, Peking Union Medical College Hospital) – Discussed guidelines (or an algorithm) on how external and internal factors in different regions may be utilized to weigh outcomes for drug efficacy and/or safety.
  • Region workgroup (Laurie Letvak, Novartis) presented a new vision for region predicated on defining region as a subpopulation.

A full set of slide presentations is available for MRCT sponsors by clicking here. Slides from Consistency Workgroup 1 are available in Chinese here.