by Monique Samuels
The use of real-world data (RWD) is growing across the industry and is increasingly encouraged by regulatory agencies worldwide. RWD can provide insights into patient populations, treatment patterns, and outcomes outside of controlled clinical trials. China, with its large and diverse patient population, offers an important opportunity for global evidence generation. However, working with Chinese RWD presents unique operational and data challenges that differ from those in the US or Europe.
Having managed projects using RWD from China, I have found that working with Chinese data sources requires a different approach and I want to share practical considerations and lessons learned from first-hand experience. These insights may help sponsors, and teams planning studies in China anticipate challenges, streamline processes, and improve study execution.
Understanding and Accessing Data Sources
Navigating Chinese RWD sources is different from working with databases in the US or Europe. Many datasets are linked to government systems, which makes direct access by sponsors rare. In most cases, local organizations act as intermediaries, extracting and managing the data on behalf of the sponsor or Contract Research Organization (CRO).
This arrangement requires early planning and clear communication. Teams need to understand who is responsible for each part of the process, from data extraction to quality checks. Unlike in other regions where access to raw datasets may be straightforward, working in China often means relying on partner organizations to provide data outputs that meet study requirements. Knowing the capabilities and limitations of these organizations upfront can prevent delays and misalignment later in the project.
Contracting and Legal Considerations
Contracting is one of the most time-consuming parts of the process.
It is generally not possible to contract directly with a government organization. Instead, sponsors must work with local data service providers who extract and manage the data. These organizations must be reviewed carefully. Due diligence should include not only the primary company, but also any parent, umbrella, or holding companies linked to it.
Early involvement of the sponsor’s legal team is strongly recommended. Clear communication channels between all parties need to be established early.
Timelines should be adjusted accordingly. Contracting in China usually takes longer than with non-Chinese data sources. Certified translations of contracts and supporting documents are often required; therefore, building extra time into the project plan for contracting and legal reviews is essential to avoid delays later.
Standard Operating Procedures (SOPs)
Strong SOP oversight is critical for successful RWD projects. At a minimum, teams should request a full list of the company’s SOPs early in the project to ensure all parts of the process are defined and clear.
In some cases, a more in-depth review of SOPs may be necessary, potentially involving audits or official inspections. When SOPs require translation, this can add further time to the project schedule. Ensuring that SOPs are complete, transparent, and aligned with study objectives helps maintain consistency across all phases of the project and supports regulatory compliance.
Feasibility Assessments
Feasibility assessments in China come with specific challenges. Language barriers can complicate discussions, particularly around clinical definitions, data variables, and study endpoints. Misunderstandings at this stage can have a downstream impact on study design, timelines, and deliverables.
In addition, diagnostic codes, disease classifications, and treatment patterns in China may differ from those used in global studies. Harmonizing these differences during protocol development is critical. Spending additional time clarifying these aspects ensures that the study population, variables, and analyses are well-defined and achievable
Project Team Communication
In China, project meetings are often most productive when conducted in the local language. Global teams should be prepared for this and ensure that Chinese-speaking team members are involved. In practice, meetings were held in Chinese, with detailed written summaries produced afterward in both Chinese and English. This ensured that non-Chinese speakers had a clear understanding of timelines, risks, mitigations, and decisions.
Regardless of meeting language, it is strongly recommended that local speakers are employed by, or contracted to, the sponsor for the duration of the project. This helps maintain consistent communication and alignment.
Patient Population, Sample Size, and Data Extraction
Depending on the disease area, patient numbers can be extremely large. While this may seem like an advantage, it can quickly become difficult to manage. In such cases, applying a more refined patient identification algorithm or using random sampling can help create a workable dataset.
Data extraction timelines should be reviewed carefully. Extraction can take longer than initially expected, particularly when large populations are involved.
Data Analysis and Data Residency
Data required for analysis cannot leave China. As a result, all analyses must be conducted locally. This makes it essential that the organization performing the analysis has a very clear understanding of the study objectives and expected outputs.
A detailed statistical analysis plan is critical, along with clear specifications for tables, listings, figures, and any other deliverables. Regular project meetings help ensure alignment, track progress, and clarify analytical questions early.
Reviewing outputs on an ongoing basis rather than waiting until the end helps prevent delays and reduces the risk of last-minute issues. A lessons-learned exercise at the end of the project is also valuable for improving future studies.
Final Thoughts
RWD studies in China are feasible and can add important value to global evidence generation. However, they require thoughtful planning, realistic timelines, strong local collaboration, and clear communication.
Many of the operational challenges can be anticipated and managed through structured processes, thorough preparation, and close partnership with local experts. By understanding these nuances, sponsors and CROs can improve study execution and generate meaningful insights that support global healthcare decision-making.
