Beijing Dispatch: R&D Growth and the Rise of Multi-Site IRB Review in China
Reading the China Daily on my way home from Beijing, a prominent article on Roche investing in a new R&D center caught my eye . Neither the prominence nor the enthusiasm of the article surprised me. During our trip my Quorum colleagues and I had attended the 8th DIA China Annual Meeting and visited the Peking University Health Science Center (PUHSC). The Roche article further illustrated what was evident throughout our week-long visit: excitement around China as a significant drug development market is reverberating.
And rightly so. China’s population is aging, its wealth is growing, and its government is increasingly investing in healthcare. Just in the past few months the Chinese Food and Drug Administration (CFDA) has announced policies to accelerate the approval of new medicines.
At DIA China, the interest in research was palpable. With titles like, “The Path Forward of Future Clinical Trials,” “Expedited Pathway to Facilitate Drug Development,” and “How to Establish Proper IND Framework,” the sessions clearly were geared toward drug development. At a packed Town Hall session, CFDA representatives commented on the need to implement pieces of the U.S. IND process.
China’s Growing Emphasis on Human Subjects Protection
This focus on the regulatory and technical side of new drug development still left time for sessions on human subject protections in clinical trials. Drug development requires clinical trials, clinical trials require participants, and participants require protection. Two speakers addressed what China is doing in this regard.
Professor Jun Zhao, Vice President of Jiangsu Province Hospital
Professor Zhao shared how the Jiangsu Province Hospital established a human research protection program. The hospital formed an ethics committee (or IRB), a separate science review committee, an internal audit committee, and a Data Safety Monitoring Board (DSMB). It sought to establish programs that met international standards, not just the requirements of the CFDA. One challenge Professor Zhao described was reconciling those external expectations with local rules. A specific example was developing standards for continuing review that could meet domestic and international requirements.
Dr. Heidi Liu, Pfizer Quality Assurance Professional
Dr. Liu discussed the ethical standards that a global pharmaceutical company expects from investigative sites in China. When selecting sites for a study, Dr. Liu said her process includes assessing the site’s ethics committee. Like Professor Zhao, Dr. Liu holds those reviewers to international standards—such as those promulgated by ICH, the World Health Organization, and the Declaration of Helsinki—as well as local CFDA requirements.
Multi-Site IRB Review
Both Professor Zhao and Dr. Liu discussed centralizing the review of multi-site clinical trials. Currently, almost every hospital and research center in China has its own ethics committee. The speakers acknowledged that large, multi-site trials are necessary if China is to develop new drug products, and that China’s individual ethics review model needs a centralized component for efficiency and expediency. Dr. Liu encouraged institutions to move toward a multi-site review model instead of having an ethics committee at each site. She noted in particular the recommendations from the U.S. Clinical Trials Transformative Initiative (CTTI) about centralizing review of multi-site studies.
Professor Zhao said that Jiangsu Province Hospital has participated in regional pilot programs to provide centralized ethics review of multi-site studies. From these pilots, he said, it was clear that a challenge for Jiangsu Province Hospital IRB and other Institutional IRBs in China is to maintain the integrity of their ethics review programs while meeting demands to oversee numerous sites.
Centralized Ethics Review at Peking University
Centralized ethics review was a topic of interest during our visit to Peking University. We at Kinetiq were honored for the opportunity to share our knowledge of multi-site review with the Peking University IRB. Among the people we met was Dr. Ji Ping, Deputy Director, Department of Project Development and Management of the Peking University Clinical Research Institute. Dr. Ping is in the process of establishing a central IRB for Shenzhen city, Guangdong province, which is working toward multi-site review capabilities.
Drug development in China will increase and so will the need for centralized multi-site IRB review. In addition to the Roche project that the China Daily reported, Novartis recently announced it will open a 1,300-person R&D facility in Shanghai. With this growth in research, individuals like Dr. Ping, Professor Zhao, and Dr. Liu are grappling with the questions of multi-site review now, to the future benefit of researchers, research participants, CROs, and sponsors like Roche or Novartis.