Syneos Health Suggests Accelerating Global Clinical Development by Enrolling Chinese Patients Early
Transitioning China from a Late Market to an Early Development Hub
Syneos Health recommends including China from the global clinical planning stage rather than adding it just before commercialization. Late inclusion can lead to separate bridging studies, protocol amendments, and approval delays. China sees about 5 million new cancer cases annually, offering a large patient pool for oncology, cardiovascular/metabolic, and immunology trials. However, this article is a sponsored development strategy content by Syneos Health, not a research paper on specific drugs or clinical trial results, so the interpretation should focus on implementation principles rather than quantified time or cost savings.
Regulatory Reforms Enhance the Economics of Concurrent Development
China joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2017 and has adopted the ICH E17 framework, which allows the use of multinational regional clinical trial (MRCT) data as a basis for approval. The National Medical Products Administration (NMPA) has implemented a 30-working-day review pathway for innovative drugs starting September 9, 2025, in addition to the existing 60-working-day implicit approval for clinical trial protocols. This pathway applies to global concurrent Phase 1 and 2 trials and Phase 3 MRCTs led or co-led by Chinese investigators, with trials required to start within 12 weeks of approval and obtain the first patient consent in China. This strengthens the regulatory foundation for designing the Chinese cohort as part of the global efficacy and safety evaluation, not as post-hoc supplementary data.
Oncology is the Most Direct Stage for Business Validation
According to IQVIA, global oncology spending is expected to grow from USD 252 billion in 2024 to USD 409 billion in 2028, making the speed of registration and regional concurrent approvals particularly valuable. Early inclusion of Chinese patients allows for early validation of biomarker-specific patient recruitment and regional response consistency in a competitive landscape that includes marketed PD-1 standard therapies such as Keytruda (pembrolizumab, PD-1) and Opdivo (nivolumab, PD-1). These products, first approved by the FDA on September 4, 2014, and December 22, 2014, respectively, serve as commercial benchmarks for comparing the efficacy, safety, and development speed of new immunotherapies. Large patient numbers alone do not guarantee faster registration, so selecting top hospitals with verified investigators, patient access, and facility capabilities is key.
Execution Risks Are Managed Through Local Expertise and Global Control
The economic benefits of early inclusion arise not from low unit costs alone, but from parallel operations such as ethics committee approvals, human genetic resource administration and control (HGRAC), personal data regulations, and contract and site initiation. Aligning statistical analysis plans, endpoints, and regional sample allocation from the start allows Chinese data to be directly used in global approval packages and reduces the risk of duplicate trials. Conversely, delayed local regulatory responses can offset cost advantages and cause data transfer and quality control issues that delay the entire MRCT timeline. Therefore, governance with centralized performance metrics and regular cross-regional reviews is a key condition for converting China's recruitment capacity into development productivity.
The NMPA's 30-working-day pathway provides a practical time-saving mechanism for global concurrent Phase 1 and 2 trials and Phase 3 MRCTs led or co-led by Chinese investigators. Considering China's approximately 5 million new cancer patients annually and the projected USD 409 billion global oncology spending by 2028, early inclusion in China influences not only patient recruitment but also the capital efficiency of concurrent approvals in China, the U.S., and Europe. Researchers must pre-design region-specific samples, endpoints, and statistical plans aligned with ICH E17 to consistently build evidence comparable to marketed PD-1 standard therapies like Keytruda and Opdivo. In the industry, operational capabilities to integrate HGRAC, personal data, ethics review, and site initiation into a global quality system are becoming key variables in CRO selection and pipeline valuation. However, the content presented should be evaluated separately from clinical data that prove recruitment period and cost savings for individual programs, as it is a sponsored strategy by Syneos Health.
Source: FierceBiotech (rss)