Framework Development for Clinical Comprehensive Evaluation of Drugs-a Study Protocol Using the Delphi Method and...

Area of Science:

• Health Economics
• Pharmaceutical Policy
• Clinical Decision Science

Background:

• Evaluating drug value for healthcare decisions is complex, requiring trade-offs among multiple objectives.
• Existing guidelines for drug evaluation need refinement for specific diseases and drugs.
• A systematic approach is needed to integrate diverse factors into a comprehensive drug assessment.

Purpose of the Study:

• To develop a two-level framework for the clinical comprehensive evaluation of drugs.
• To establish a robust methodology for weighting and scoring drug evaluation components.
• To provide a tool for evidence-based decision-making in healthcare regarding drug adoption and use.

Main Methods:

• Development of a two-level evaluation framework based on the Chinese Guideline for Clinical Comprehensive Evaluation of Drugs.
• Validation of second-level components using the Delphi method.
• Determination of index weights and scoring criteria via the Analytic Hierarchy Process (AHP).
• Integration of therapeutic effects and evidence quality into scoring criteria.

Main Results:

• A validated two-level framework with defined indicators (safety, efficacy, cost-effectiveness, novelty, suitability, accessibility).
• Established index weights and scoring criteria through Delphi and AHP.
• A method for calculating a comprehensive drug score based on evaluated evidence.

Conclusions:

• The developed framework offers a structured approach to drug value assessment.
• The methodology ensures objective evaluation by incorporating expert consensus and hierarchical analysis.
• The comprehensive drug score facilitates informed, evidence-based healthcare decisions.