In the application for the domestic registration certificate of the fat transfer device, clinical data is a key element to prove the safety and efficacy of the product. Here are some suggestions on how to prove clinical evidence:
Sound study design:
Choose an appropriate study design, such as a randomised controlled trial, a single-arm trial, etc., to ensure robust evidence. Ensure that the study design answers the scientific questions of interest.
Sufficient sample size:
Ensure that the study sample size is sufficient to improve the statistical power of the study. Adequate sample size contributes to reliable clinical evidence.
A definite endpoint:
Determine the primary and secondary endpoints of the study to evaluate the safety and efficacy of the product. This may include improvement in clinical symptoms, changes in biological markers, etc.
Good data collection and management:
Develop a detailed data collection and management plan to ensure the quality and integrity of your data. Standardized data collection tools are used, and regular data monitoring and cleaning is carried out.
Statistical Analysis Plan:
Develop a statistical analysis plan to ensure proper analysis of clinical data. This may include descriptive statistics, survival analysis, analysis of variance, etc.
Control group selection:
If a control group is included in the study design, ensure that the choice of the control group is reasonable and can help distinguish the effect of the product.
Safety Monitoring: Design an effective safety monitoring plan to monitor and report adverse events in a timely manner. Conduct a comprehensive assessment of the safety of the product.
Interpretability of results:
The results should be interpretable and provide a clear indication of the clinical efficacy and safety of the product. Avoid overly complex or obscure results.
Control for bias: Take measures to control for bias that may affect the outcome of the study, such as randomization, double-blind design, etc.
Ethics Review and Approval:
Ensure that the study protocol is ethically reviewed and approved to guarantee the ethical compliance of the study.
Communication with NMPA:
Maintain timely communication with the NMPA to obtain feedback on clinical data and ensure that the data meets its requirements.