China accounts for 11% of the global pharmaceutical market, and this figure is expected to grow at an annual rate of 12% to reach $300.9 billion by 2025. With an increasingly aging population, an extensive network of healthcare infrastructures, and an enhanced regulatory framework, China has increased its attractiveness as a destination for clinical trials reaching a 27.7% share of global clinical trial activity by 2022 according to Global Data. The country's clinical trials sector remains mainly domestic but clinical trials in China sponsored by Western pharma companies have grown steadily over the past decade, from about 100 trials per year in 2010 to about 350 in 2021, and foreign sponsors trials continue to increase.
In this post we will review the opportunities in China’s clinical trial environment, address the challenges to be faced when conducting trials in China, and identify keys to optimize time and costs and achieve program success.
One of China's main attractions as a clinical trial destination is its large population of treatment naïve patients. Not only does the country have a large pool of untreated patients, but some of them see clinical trials as an opportunity to access new therapies, which can help accelerate recruitment. However, it should be kept in mind that there is high competition for patient participation in clinical trials, so to ensure adequate recruitment, proper planning and good relationships with sites and site staff are essential. An experienced CRO in China, such as Linical, can help navigate this process.
Changes in the regulatory landscape
In order to increase efficiency in drug development in the country, the National Medical Products Administration of China (NMPA) has updated its review and registration processes by introducing regulatory fast tracks such as innovative and orphan drug designations, priority reviews, and reimbursement reforms. In terms of clinical trial quality, China has improved significantly since 2015 by reinforcing inspections on the authenticity and integrity of data and regulatory documents. Since 2017, China is a member country of the International Conference on Harmonization (ICH) and has updated the clinical trial approval system by significantly shortening the IND approval timeframe. Additionally, since 2019, sponsors are required to submit notifications prior to electronic data capture (EDC) which involves sharing clinical trial data for adverse event (AE) reporting to foreign parties of interest, including the U.S. FDA and other regulatory agencies. Despite advances, Chinese regulations around clinical trials can be complex and are constantly evolving, and it is imperative to have experts in place to ensure proper understanding and compliance with regulatory requirements.
Infrastructure and healthcare personnel
China has a strong clinical trial infrastructure, with many established investigator sites and a strong network of professionals and advanced technologies. Chinese investigators may sometimes have less clinical trial experience compared to the US and Europe, but are inclined to learn and collaborate, making them excellent partners.
Conducting clinical trials in China is more cost-effective, as labor and infrastructure costs are lower. Thus, direct costs have been estimated to be up to 30% lower than in the U.S. so that even sponsors with limited budgets can consider China for their clinical development programs. However, this cost advantage can be affected by multiple factors, including the type of study, the phase of the trial, the complexity of the protocol, and the therapy in question.
Despite the advantages, it is clear that conducting clinical trials in China involves significant challenges, as the country has unique features and organizational structures that are different from those in the West. Thus, in addition to language and cultural barriers (traditional Chinese medicine still plays a major role in healthcare), regulatory, organizational, and logistical issues must be carefully considered, as well as the relationship with all stakeholders. Investigators may need training, and communication/relationships with regulatory authorities needs to be strong to ensure the smooth execution of the project.
Keys for optimal clinical development in China
To ensure the success of the Chinese clinical trial, it will be necessary to have a strong study plan. This includes adapting it to Chinese clinical practice, selecting the best possible sites based on specific demographic and epidemiological characteristics, managing linguistic and cultural aspects, fostering effective communication between all parties involved in the project (sponsor, investigators, site’s staff, etc.) and maintaining interaction with local regulatory authorities. A Chinese CRO with local resources, experience, and a strong network will be needed to lead these tasks as well as proactively identify and manage the potential risks associated with conducting the study at all levels (regulatory, operational, logistical, etc.). This CRO in China will partner with you to establish the necessary roadmap to optimize the time and cost of the study. It will also be critical that data management is aligned not only with local requirements but also with international standards in order to ensure the reliability and quality of the study results.
Originally established in Japan, Linical is global Contract Research Organization (CRO) for full-service drug development with the experience, resources, and know-how to successfully conducting clinical trials throughout the Asia-Pacific (APAC) region, including China.
As an experienced CRO in China, our team of local area experts possess deep regulatory knowledge and excellent relationship with sites, KOLs and PIs to provide guidance and the best solutions to avoid obstacles and ensure the success of your clinical studies in China.
Linical provides a full spectrum of drug development services from early stage to large-scale, multinational studies. Our areas of focus include Phase I-IV studies in oncology, neurology & psychiatry, immunology & vaccine, and endocrinology & metabolic diseases.
Contact us below to learn more about our CRO services in China.