Chapter 2 Guideline for Drug Effectiveness Evaluation
This chapter primarily introduces the definition,process,and specific evaluation methods of drug effectiveness evaluation.Drug effectiveness evaluation compares the clinical therapeutic effects of a subject drug with a reference drug in treating specific diseases,to assess whether the subject drug can significantly improve patient outcomes and achieve important health benefits.The evaluation process begins by clarifying the evaluation question,which involves defining the target population,the drug under evaluation,the reference drug,and outcome measures according to the PICO principle.Based on the characteristics of the drug,the disease,the sufficiency of existing literature,and the availability of data,appropriate evaluation methods are selected,including secondary research,real-world studies,and RCTs.Secondary research systematically collects and analyzes existing literature;real-world studies use data from actual medical environments to reflect the drug's therapeutic effects;RCTs use randomization to clarify the causal relationship between the intervention and outcomes.Additionally,this chapter discusses the importance of quality control to ensure the authenticity,accuracy,and reliability of the evaluation results.
drug effectivenessguidelinesecondary researchreal world study
NETL
NSTL
万方数据
