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[Clinical evaluation: from intermediate to surrogate criteria]
J P Boissel1, L Perret, G Bouvenot
1Hôpital Neuro-Cardiologique, Université Claude Bernard, Service de Pharmacologie Clinique, Lyon, France.
Therapie
|July 1, 1997
Summary
Drug development often uses surrogate outcomes as substitutes for clinical outcomes. This review examines their validity across various diseases and proposes a strategy for their appropriate use in drug authorization.
Area of Science:
- Pharmacology and Clinical Trial Design
- Biostatistics and Evidence Synthesis
Context:
- Drug development and evaluation frequently employ surrogate outcomes.
- Surrogate outcomes are intermediate measures used in place of definitive clinical outcomes.
- Criteria for a valid surrogate outcome include ease of measurement and predictive relationship with the clinical outcome.
Purpose:
- To critically assess the validity of surrogate outcomes in drug development.
- To review the application and reliability of surrogate outcomes across diverse therapeutic areas.
- To propose a pragmatic strategy for the validation and appropriate utilization of surrogate outcomes.
Summary:
- The study evaluates the soundness of using surrogate outcomes in drug development and authorization.
- It reviews evidence from therapeutic areas including hypertension, venous thromboembolism, AIDS, osteoporosis, and hepatitis C.
- A strategy is presented for validating and ensuring the proper use of surrogate outcomes.
Impact:
- Provides a framework for the reliable use of surrogate outcomes in pharmaceutical research.
- Aims to improve the efficiency and validity of drug evaluation processes.
- Contributes to evidence-based decision-making in regulatory drug approval.