Assessing the clinical value of pharmaceuticals is crucial for comprehensive evaluation in clinical practice and plays a vital role in supporting decision-making for drug supply assurance.Real-world data(RWD)offers valuable insights into the actual diagnosis and treatment processes,serving as a significant data source for evaluating the clinical demand,effectiveness,and safety of drugs.This technical guidance aims to elucidate the scope of application of RWD for the clinical value assessment of pharmaceuticals,as well as the key considerations for conducting value assessment research.These considerations include identifying the dimensions of clinical value that necessitate RWD and effectively utilizing RWD for evaluation purposes.Additionally,this guidance provides essential points for implementing pharmaceutical clinical value assessment based on real-world data,with a specific focus on study design and statistical analysis.By doing so,this guidance assists researchers in accurately comprehending and standardizing the utilization of real-world research in conducting pharmaceutical clinical research.
关键词
真实世界数据/临床价值评价/医保决策/技术规范
Key words
Real-world data/Clinical value evaluation/Health insurance decision/Technical guidance
维普
万方数据