Quantitative risk-benefit assessment has been more and more important for regulatory agencies and pharmaceutical industry for the new-drug – approval process and post-marketing surveillance.
Our purposes are to identify and describe quantitative approaches to risk-benefit assessment and to highlight the implications of their differences for the pharmaceutical industry and regulatory agencies.
Twelve quantitative approaches to risk-benefit assessment were reviewed in this paper, including the Quantitative Framework for Risk and Benefit Assessment, Benefit-Less-Risk Analysis, the Quality-adjusted Time without Symptoms and Toxicity, Number Needed to Treat and Number Needed to Harm and their relative-value-adjusted versions, Minimum Clinical Efficacy, Incremental Net Health Benefit, the Risk-Benefit Plane, the Probabilistic Simulation Method, Multi-Criteria Decision Analysis, the Risk-Benefit Contour, and the Stated Preference Method. Whereas some approaches rely on subjective weighting schemes or non-statistical assessments, other methods assess joint distributions of benefit and risk.
Over a dozen high-profile brand-name drugs, including rofecoxib, troglitazone, cisapride, and cerivastatin, were withdrawn from the market. Both regulatory agencies and pharmaceutical industry pledged to evaluate the risk and benefit more effectively for assessing drug safety and efficacy.
Both FDA and EMEA have been working on developing and improving a systematic risk-benefit assessment for the new drug development.
This will be discussed in an upcoming issue of Value in Health, the official journal of the International Society for Pharmacoeconomics and outcomes Research.
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 4,000 clinicians, decision-makers, and researchers worldwide.
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