Key Considerations

临床试验方案是指导整个试验实施的核心文件，涵盖了从产品预期用途到试验结果发表的各个方面。设计时应重点关注：产品的临床应用意义、试验设计的科学性、评价方法的有效性和安全性、试验流程的合理性、统计学考虑、不良事件报告规定、数据处理方法、财务保险安排，以及结果发表约定。这些要素共同确保了临床试验的全面性、科学性和可靠性，为医疗器械的研发和应用提供了坚实的基础。

• The product's intended use, usage scenarios, and the epidemiological significance of its clinical application.
• The rationality and scientific validity of the trial design approach.
• The design of efficacy and safety evaluation methods.
• The logical flow of the clinical trial process.
• Statistical considerations.
• Guidelines for reporting adverse events and device defects.
• Data processing methodologies.
• Financial and insurance arrangements.
• Agreement on the publication of trial results.