China Global Clinical Trial Potential: Misperceptions Drive Global Biotechs Apprehensions

China's growth in the clinical trials sector is undeniable. As of 2022, China accounted for a whopping 27.7%1 share of the global clinical trial activity, up significantly from its ten-year average of 16.5%.1

This surge reflects China's concentrated efforts to revamp its regulatory framework, enhance trial quality, and increase cost-efficiencies, positioning itself as a global clinical research powerhouse.?

Initial growth was driven dominantly by local industry. However, more recently, global western powerhouses including Novartis, Pfizer, Boehringer Ingelheim, Johnson & Johnson, Allergan, Roche, Eli Lily and Merck are all active in the region.2

Yet, despite these advancements, apprehensions persist amongst global biotech.?

This article aims to shed light on China's evolving clinical landscape and its vast opportunities.???

Trial and data quality?

Many misconceptions about running clinical trials in China are concerned with the quality of data and the reliability of the conduct of trials. However, it's important to recognize that the landscape of clinical trials in China has evolved rapidly.?

In the last decade, China has made significant strides in enhancing the quality and reliability of its clinical trials.??

• 2015 National Medical Products Administration (NMPA), China’s primary authority for overseeing the approval of clinical trials, enhanced its emphasis on data integrity. This included rigorous inspections to ensure data authenticity, integrity, and conformity to normative documentation standards.?
• 2017, China took a step towards international collaboration by joining the International Conference on Harmonization (ICH). 2 This integration meant streamlining their practices in line with global clinical trial standards. In fact, China has since embraced and implemented 46 ICH guidelines, reflecting a commitment to international best practices.?
• 2019 Regulation on Human Genetic Resources enforces transparency, mandating that multinational companies intending to conduct trials in China file notifications before electronic data capture. This means sharing of clinical data even for adverse-event reporting to foreign parties of interest, including the US FDA and other regulatory agencies.2
• ?1 July 2023 Implementation Rules for the Management Regulations of Human Genetic Resources (HGR)?came into effect in China.?These rules reflect China’s heightened focus on strengthening the regulation of HGR to safeguard national biosecurity. The objective is to strengthen the protection of human genetic resources, promote their appropriate utilization, and enhance regulation and supervision.3
• ?Data from China is acceptable to FDA, EMA and the local NMPA. Collecting data from China only may not be ideal where sponsors are looking to gain regulatory approval overseas. There have been several high-profile FDA rejections where the FDA ruled that China-only studies did not meet the FDA criteria in respect of its foreign data requirements, as China-only trials may not reflect US population diversity, as well as the current US treatment landscape. If overseas regulatory approvals are required, multiregional clinical trials are generally recommended, and drug developers increasingly pursue simultaneous pre-IND meetings with both the US FDA and China NMPA overseas.?

Cost and efficiency?

Running clinical trials in China is also more cost-effective than in many other countries, making it an accessible option for sponsors even with limited budgets. With lower costs of labour, infrastructure and study procedures, conducting clinical trials can be up to 30% lower than in the US.?

In addition, the willingness of the population pool often streamlines recruitment efforts and accelerates the speed to market.?

The local population increasingly views these trials as gateways to new treatments, promoting faster participant recruitment. China's major hospitals are especially appealing for studies requiring large numbers of participants.??

With well-established trial sites, experienced teams, an extensive network of therapeutic specialists, and advanced technology, there is a strong foundation for successful clinical trials. The adoption of remote or virtual trial methods has surged, especially during the Covid-19 pandemic.?

Regulatory processes?

While intricate, China's regulatory landscape is by no means an insurmountable challenge. However, it demands a detailed understanding, but navigating it can be straightforward with the right expertise.?

NMPA is at the forefront of these regulatory processes, actively refining its product review and registration processes.??

They have also ushered in regulatory modernization by overhauling the traditional clinical trial approval process. This move was transformative, bringing the IND review timeline down to three months.2 The time period for regulatory approval has also been substantially shortened from 265 days to 65 days.?

The goal behind these processes is to elevate efficiencies in drug development. With the introduction of regulatory acceleration mechanisms, there's a significant effort to boost innovation. Breakthrough and orphan designations, priority reviews, and comprehensive reimbursement reforms have all been instated by the NMPA to promote earlier application processes and speed up approvals.?

This is where the invaluable role of local Clinical Research Organizations (CROs) becomes evident. Equipped with on-ground expertise and a keen understanding of the regulatory shifts, they act as a linchpin in ensuring the drug development process stays on track.?

Seizing opportunities in China's clinical trial landscape?

China's clinical trial landscape has grown into a hub of quality, efficiency, and innovation. Through systematic reforms, China has progressively aligned their clinical research environment with global benchmarks.??

China's clinical trial sector offers numerous opportunities for US biotechs looking for cost-effective and efficient places to run clinical trials.?

China is one of the largest pharmaceutical markets in the world. Conducting clinical trials in China can help pharmaceutical companies gain early access to this market and better understand the specific needs and preferences of Chinese patients. It also allows them to generate data that can support regulatory approvals and commercialization in China.?

Local expertise provides assurance?

Cross-border trade is always complex. HiRO has intimate expertise in the Chinese clinical research space and our extensive global network, which makes us an ideal partner.??

We are dedicated to providing a full range of solutions and services to accelerate the commercialization pathway of clinical research. HiRO works hand-in-hand with biotech and pharmaceutical companies to bring new products from the lab to market, delivering new innovative medicines to patients worldwide.?

Get in touch or follow us here for more insights.?

References:?

1.https://www.clinicaltrialsarena.com/marketdata/china-accounts-for-27-7-share-of-global-clinical-trial-activity-in-2022/ ?

2. https://www.clinicaltrialsarena.com/features/china-clinical-trial-challenges-cta-exclusive/?cf-view ?

3. https://www.china-briefing.com/news/chinas-human-genetic-resources-regulation-implementation-rules-key-points-for-foreign-stakeholders/ ?

4. https://www.clinicalleader.com/doc/report-reflects-huge-growth-of-clinical-trials-in-china-0001 ?