China NMPA released the finalized version of the "Guideline on Medical Device Real-world Study Design and Statistical Analysis" on January 15, 2024, following the draft version's release on September 28, 2023. It provides comprehensive guidance for real-world study design and the statistical analysis.
Here are a few highlights in the statistical analysis section:
1."Determining Confounding Variables that Need Modification" for controlling bias in non-randomized real-world study designs.
2. Descriptions of different types of real-world study designs, such as Pragmatic Randomized Controlled Trials (pRCTs) and Observational Real-World Studies. The latter encompasses various study designs like Descriptive Study Designs, Cohort Designs, Case-Control and Derived Designs, and using Real-World Data as External Controls.
3. Essential considerations for designing real-world study protocols, including defining study background and objectives, evaluating feasibility, selecting appropriate research designs, creating study flowcharts, defining study populations, assessing device exposure and potential biases, determining control groups, defining outcome measures, developing data collection methods, adjusting for confounding variables, defining follow-up times, and calculating sample sizes and statistical power.
4. The importance of Quality Control in Data Quality, Bias Risk, Assessment of Bias, and Ethical Review, etc.
The guideline provides more guidance for overseas manufacturers seeking early commercial sales and collecting real world data in Hainan Boao. Manufacturers can utilize real-world data (RWD) collected through real-world studies (RWS) to support their national NMPA registration approval.
I'd love to hear your thoughts on your experience in RWD/S in Hainan or China in general. Please feel free to email me if there are any questions.
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Grace Fu
China Med Device, LLC
gpalma@ChinaMedDevice.comPhone US: (978) 390-4453
Phone China: 18201749732
www.ChinaMedDevice.com------------------------------