When developing clinical study protocols for NMPA registration of invasive blood pressure monitoring devices in China, it's essential to consider several recommendations and key considerations to ensure the study is well-designed, meets regulatory requirements, and generates robust clinical evidence. Here are some recommendations and considerations for clinical study protocols:

1. Study Objectives and Endpoints

• Define Clear Objectives: Clearly state the primary and secondary objectives of the study, focusing on evaluating the device's safety, efficacy, and performance parameters such as accuracy, precision, and usability.

• Selection of Endpoints: Identify specific endpoints that align with the study objectives, including clinical outcomes related to blood pressure measurement accuracy, device reliability, and usability in clinical settings.

2. Study Design

• Type of Study: Choose an appropriate study design (e.g., randomized controlled trial, non-randomized trial, observational study) based on device classification, intended use, and regulatory requirements.

• Comparator and Control: Specify the comparator device or method against which the device will be evaluated. This could include validated non-invasive blood pressure monitors or gold standard methods like arterial line catheters.

3. Patient Population

• Inclusion and Exclusion Criteria: Clearly define criteria for patient eligibility to ensure the study population represents the intended use population for the device. Consider factors such as age, medical history, and clinical conditions affecting blood pressure.

• Diversity in Participants: Aim for diversity in participant demographics to reflect the real-world clinical application of the device.

4. Device Installation and Training

• Device Handling: Detail procedures for device installation, calibration, and usage according to manufacturer instructions and study protocol. Ensure consistency across study sites to minimize variability.

• Investigator Training: Provide training to investigators and site staff on device operation, data collection methods, and adherence to study protocols.

5. Data Collection and Analysis

• Data Collection Methods: Specify standardized procedures for collecting and recording data on blood pressure measurements, including timing of measurements and conditions under which they are taken.

• Statistical Analysis: Plan robust statistical analyses to evaluate the device’s performance compared to the comparator device or method. Include methods for calculating sensitivity, specificity, accuracy, precision, and other relevant metrics.

6. Ethical and Regulatory Considerations

• Ethical Approval: Obtain approval from independent ethics committees (IRBs) at each study site to ensure compliance with ethical principles, patient rights, and confidentiality.

• Regulatory Compliance: Align the study protocol with NMPA regulations and guidelines, including Good Clinical Practice (GCP) standards, to facilitate regulatory approval and compliance.

7. Safety and Monitoring

• Safety Monitoring: Implement procedures for monitoring participant safety throughout the study period. Define criteria for reporting adverse events and device-related complications.

• Data Monitoring Committee: Consider establishing a Data Monitoring Committee (DMC) to oversee study progress, participant safety, and data integrity.

8. Documentation and Reporting

• Study Protocol Document: Prepare a comprehensive study protocol document that includes all relevant details, such as study objectives, design, methods, endpoints, and statistical analysis plan.

• Clinical Study Report: After completion of the study, compile a detailed clinical study report summarizing study findings, data analysis results, participant demographics, adverse events, and conclusions regarding the device’s performance.

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