China can play several roles in a global clinical development program, from supporting a capital-efficient proof-of-concept study to contributing evidence within a multiregional clinical trial. In this sponsored episode of The Top Line, Caidya Chief Operating Officer Mike Clay and Vice President of Business Development Jinye Shen join Fierce Life Sciences’ Will Herth to discuss how sponsors can decide when and how to include China. 
 
The conversation examines China-only, multiregional and sequenced development approaches, and how the intended use of China-generated evidence should shape the strategy. They also explain why a large patient population does not automatically equal recruitable patients, highlighting the importance of site-level feasibility, investigator networks, local treatment practices, competing trials and referral pathways. 
 
Additionally, they discuss the risks of considering China too late, including protocol redesign, duplicated work, delayed trial starts and reduced regulatory flexibility. This conversation assesses practical perspectives on regulatory planning, bridging-study questions, operational execution, governance, data quality and the balance between local expertise and global accountability. 

China can play several roles in a global clinical development program, from supporting a capital-efficient proof-of-concept study to contributing evidence within a multiregional clinical trial. In this sponsored episode of The Top Line, Caidya Chief Operating Officer Mike Clay and Vice President of Business Development Jinye Shen join Fierce Life Sciences&rsquo; Will Herth to discuss how sponsors can decide when and how to include China.&nbsp; &nbsp; The conversation examines China-only, multiregional and sequenced development approaches, and how the intended use of China-generated evidence should shape the strategy. They also explain why a large patient population does not automatically equal recruitable patients, highlighting the importance of site-level feasibility, investigator networks, local treatment practices, competing trials and referral pathways.&nbsp; &nbsp; Additionally, they discuss the risks of considering China too late, including protocol redesign, duplicated work, delayed trial starts and reduced regulatory flexibility. This conversation assesses practical perspectives on regulatory planning, bridging-study questions, operational execution, governance, data quality and the balance between local expertise and global accountability.&nbsp;

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning. 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.&nbsp;

The Top Line

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We’ll analyze the week’s biggest business news—from mergers and marketing to drug R&D and device development. Available every Friday morning.

 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We&rsquo;ll analyze the week&rsquo;s biggest business news&mdash;from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.
&nbsp;