The Use of Real-World Data to Support Clinical Evaluation of Medical Devices in China

At the beginning of 2024, the China Medical Device Evaluation Center (CMDE) published a new guideline to promote the real-world evidence used for regulatory decision-making. This guideline refines the requirements listed in the "Technical Guidelines of Using Real World Data to Support Clinical Evaluation of Medical Devices (Trial Version)" in 2020. It further clarifies the design and statistical analysis when designing and collecting real-world data. 
 
In the 2020 trial version, five topics have been addressed. Specifically, the meaning of real-world data (RWD) and real-world evidence (RWE) have been clearly defined, the advantages and limitations of real-world studies (RWS) have been discussed, common data sources and quality evaluation, types of RWS designs and methods for statistical data analysis, and situations where RWD can be applied in the clinical evaluation process have also been touched.  
 
In the new 2024 version, the expectations on the study type and design, the recommended methods of statistical analysis, and the structured template of planning and reporting study are elaborated.  
This blog will walk you through six details to unveil the authority's current views. 
 

1. The scope of this guideline applies to medical devices when a manufacturer considers utilizing RWE to support clinical evaluation. IVD products are not covered. The guideline also reiterates that the RWD is only used as additional evidence to supplement the traditional clinical evaluation data; however, the RWD itself may not be sufficient to replace a proper study. 
   
   
2. The common types of real-world study include:
   
   • Pragmatic Randomized Controlled Trial (pRCT).
   • Observational study.
   • A control group to a single-arm study.
    
   PRCT study ranks high in the evidence hierarchy. It combines the advantages of randomization and real-world data by effectively controlling bias, so the results are normally high-quality. pRCT requires a relatively large sample size, which is more suitable for an application that needs a large population enrolment. The observational study includes:
   
   • Cohort studies (very often based on the national and international registries)
   • Case-control 
   • Cross-sectional study
   • Case report study
     
   
   
   
   
   
   
3. The data quality shall be controlled to eliminate bias and variables. For example, in the design phase of a prospective study data collection, it is recommended to establish specific diagnostic outcomes and criteria in advance and align them with the implementation process, such as testing, examination, and scoring, to ensure the accuracy and consistency of the collected data.  For retrospective studies, it shall list all the possible information, including data sources to be used, field information, patients' samples, missing data, and accuracy of data records, etc. The study plan needs to specify possible biases, strategies to avoid these biases, and detailed measures to handle biases during the analysis phase.
   
   
4. A proper statistical plan, calculation method, and scientific basis shall be set up before the study. Considering that the same data might result in different values by using different statistical methods, the statistician shall not freely choose analysis methods and parameters. Some statistical analysis methods like Mantel-Haenszel, EPV (Events Per Variable), or Bayes could be used.
   
   
5. The study's reporting shall also be standardized. Some helpful guidance documents help to build up a well-contented report, such as CONSORT guidance or STROBE or STaRT-RWE checklist. 
   
   
6. The ethical review and informed consent for real-world research must comply with local laws and regulations where the study is performed. China's domestic RWS shall comply with the Helsinki Declaration and obtain the Human Genetic Resources Administration of China (HGRAC) approval.

In summary, the authority will assess the real-world data quality and the control of bias and variables to verify if the study has a sound database to prove the intended product's safety and effectiveness.  

How can we help you? 
If you would like to know what products have been approved in China using real-world evidence in the recent five years or more successful examples of using RWE to obtain market approval, feel free to contact Qserve for more information.  

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