Clinical Development in China:
Collaboration and Innovation to Address Challenges

Hannah Chen
Theme Lead,
Director,
Asia Pacific Strategy Lead,
JNJ

he Clinical Development Theme at the 10^th DIA China Annual Meeting examined how collaboration and innovation are critical in addressing current challenges in the clinical trial environment in China.

Background


In May 2017, the China Food and Drug Administration (CFDA) issued four new draft policies for public comment in its series of regulatory reforms (which began in 2015) to accelerate the review and approval, and improve the quality, of new drugs and medical devices. In June 2017, ICH and the CFDA jointly announced that CFDA had joined ICH as a Member. “CFDA is continuing to enhance the regulatory standards and regulatory system to promote innovation to improve the drug R&D ecosystem and, ultimately, to improve the access of medicines to patients,” explained Dr. Ling Su in a DIA podcast.

While regulations governing clinical research activities in China have been continuously evolving, the scale, complexity, and cost of these trials have simultaneously and exponentially increased. This explosion of connected factors will require all stakeholders to collaboratively work toward innovative approaches to overcome these and other challenges to innovative clinical research and healthcare product development in China.

Key Takeaways

• Upgrading the overall capability of China’s clinical research system is both essential and urgent; this includes refining hospital infrastructures, systematically providing clinical research education and training to medical doctors, and establishing incentive and performance measures that encourage doctors to conduct clinical research in China.
• Qualified clinical professionals and clinical centers are the single greatest success factor in conducting clinical research in China, although effective vendor selection and management is a major influence on clinical operations.
• While training to ensure that investigators have a clear understanding of adverse event reporting requirements is important, continuous education and monitoring to help site staff comply with these requirements is more effective.
• New technologies and innovative solutions in clinical development can not only provide better experiences for investigators and patients, they can also provide industry and regulator decision makers with more and better information to develop their audit and inspection programs.

These recommendations emerged from the six sessions dedicated to clinical development in China. These sessions included a hospital presidents’ forum; presented the impact of a clinical quality management system (cQMS); overviewed the entire clinical trial adverse event reporting lifecycle from collection to processing, to analyses and summaries, to submission and authority review; and previewed new clinical trial support technologies.

Collaboration amongst industry, global health authorities, patients, and investigator sites, may test the boundaries of innovation. But the strategy and practice of efficient, collaborative clinical operations will accelerate progress in prevention, diagnosis, treatment, and—ultimately—cures.