Cancer Clinical Trial Sites Moving Globalization and Professional Development Forward

Meeting Highlights: DIA China 2021

Cancer Clinical Trial Sites Moving Globalization and Professional Development Forward

Wu Dawei
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences

ince China implemented the filing system of drug clinical trial institutions in December 2019, the capacity of clinical trials in medical institutions has been steadily upgraded and a large number of new sites have emerged. According to the National Medical Products Administration (NMPA) database, the total number of drug clinical trial sites registered nationwide exceeded 1,000 by the end of 2020. Improving the quality and efficiency of their own trials by improving the knowledge and training of their study staff, and integrating into the global drug development process, have become key issues for Chinese clinical trial sites.

One example of this dual track and drive to improve the quality of both the clinical trials and the professional development of the staff coordinating these trials comes from the NCC Clinical Trials Center. The team of full-time investigators built into these study sites consists of physicians expert in both clinical practice and clinical research.

In addition to tips for developing clinical trial sites for drug studies, the Patient-Centered Clinical Study Needs and Practice session at DIA China 2021 focused on numerous hot topics facing clinical sites and research professionals in China.

Clinical Cancer Needs

The number of cancer drug clinical trials in China showed remarkable growth in the last decade (Figure 1), illustrating the pharmaceutical industry’s rising capacity overall. However, the number of cancer trials and clinical needs are not yet perfectly matched. A large proportion of trials have focused on two of the most prevalent cancers both globally and in China, non-small cell lung cancer (NSCLC) and breast cancer. But local trials have so far proven insufficient to address gastric cancer, liver cancer, and esophageal cancer, which are also common in China and associated with different causes compared with Western countries. Rare cancers without effective treatment have also not received enough attention. This is mainly due to the common “fast-follow” mode of Chinese pharmaceutical companies, which bases trial designs on experience from similar products from Western countries. But the future of cancer drug clinical development will not be found in blindly imitating the development pathway of similar drugs, and research in China should focus on cancers endemic to China.

Ethics Reviews

Cell therapy, gene therapy, and similar emerging cancer treatment approaches are challenging the quality of ethics review and driving IRBs to constantly update their scientific knowledge. Simultaneously, the government is promoting mutual recognition of ethics review, or the central IRB system, to improve overall efficiency. Sponsors pay attention to the efficiency of the ethics review process, but this process must also guarantee quality from the patient protection perspective. Balancing the efficiency and quality of ethics review remains a hot topic for all clinical trial stakeholders in China.

Sponsor-Site Communication

Information and communication between study sponsors and clinical sites is often asymmetrical. Communication difficulty in the process of trial negotiation can ultimately impact trial efficiency and progress. In the present circumstances of strong national support for the pharmaceutical industry, sponsors and sites in China are trying to strengthen their collaboration by combining processes and implementing remote techniques, and many clinical trial sites in China have provided handbooks, customized contract templates, and online trial management platforms to their study sponsors.

Managing Investigator-Initiated Trials (IITs)

IITs are also booming in China. From 2016 to 2020, the NCC initiated 891 IITs covering cancer diagnosis and prevention, medical technologies (devices), and real-world studies, one and one-half times the total number of sponsor-registered trials in this same period. IITs in China are regulated by the National Health Commission, which is developing updated IIT management regulations, instead of the NMPA. The majority of anticancer drug IITs in China are mainly exploratory trials for marketed drugs, especially PD-1/PD-L1 antibodies. There are also early-stage IITs for pre-marketed cell therapies and other immune agents. Local academic institutions and companies are providing greater support for IITs throughout China.

Patient-Centric Clinical Trials

Patient-focused drug development is still in its infancy in China, and the NMPA only recently put forward the first document officially mentioning the idea. According to this guideline, critical steps to give patients more input into clinical trial design include clarifying methods to identify what is important to patients; and selecting, developing, or modifying fit-for-purpose clinical outcomes, then incorporating assessments of these clinical outcomes into endpoints fit for regulatory decision making. Some patient mutual aid organizations have been operating in China for many years, several on a relatively large scale.

Future Orientation of Research and Research Professionals

The future of cancer clinical studies in China is oriented toward rare cancers and cancers endemic in China and will also focus on cellular and gene therapies. Clinical drug development for rare cancers in China is still in the early stage but has been attracting more attention from both industry and academia, because these products may be granted fast-track or priority-review designation based on the latest NMPA regulations. NCC has also recently established the definition of rare cancers in China, demonstrated the gene map of some cancer types (such as adenoid cystic carcinoma), and launched a platform study guided by genotyping for rare cancers.

NMPA recently approved China’s first cellular product (CD19 CAR-T), and the total number of clinical trials in China for solid tumor cell or gene therapies ranked second in the world from 2010 to 2019 (Figure 2). The focus of research into cellular and gene therapies has been shifting from hematologic malignancies to solid tumors, and clinical development in China in the field of solid tumors is expected to keep pace with that of the US.

Well-designed drug development pathways result from the collaboration of sponsors, investigators, ethics committees, and patients, a network in which the study site and attending research professionals play a key connecting role. Many clinical sites are also recognizing that clinical research is both a special science and a professional discipline and are pursuing the benefits of professional development pathways. Full-time clinical trial physicians, pharmacists, nurses, and managers are emerging in Chinese clinical sites. Comprehensive trainings covering trial execution, management, design, statistical analysis, and clinical pharmacology are provided by clinical sites for investigators, and by medical schools for students.

The growing importance of medical and academic institutions in the future of clinical research in China was illustrated in various ways at DIA China 2021:

Estimated 10% of meeting participants came from academic institutions
60 of these academic institution participants served as speakers
27 medical institutions participated in the meeting exhibition
The Patient-Centered Clinical Study Needs and Practice session attracted more than 1,000 attendees and became a “meeting hotspot.”

Graph Annual number of cancer drug clinical trials initiated in China

Figure 1: Annual number of cancer drug clinical trials initiated in China, 2009–2018.

Figure 2: Top 20 countries with the most clinical trials of cell and gene therapies for solid tumors, 2010–2019.

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