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Special Section: Benefit:Risk Evaluation in Clinical Trials Guest Editor: Scott Evans, PhD Hurvurd Universitv

The monitoring and evaluation of benefit:risk is a fundamental element of clinical trials and drug development. Regulators weigh the benefits and risks when evaluating drugs for approval: sponsors assess the benefit:risk profile of their drugs to aid development decisions; and data monitoring committees make recommendations regarding study conduct based on benefit:risk assessment during interim data analyses. Despite benefit:risk assessment lying at the heart of the drug development process, published guidance on methods for benefit:risk analysis is lacking. Meanwhile, incidents of drugs being removed from the market for safety concerns, such as terfenadine or rofecoxib, raise many questions. Are we collecting the right data for appropriate benefit:risk assessment? Do we need to revise our traditional approaches to designing, monitoring, analysis, and reporting of clinical trials to better assess benefit:risk? Such incidents remind us that more effective but transparent methods and strategies for assessment of benefit:risk are needed. Recognizing this, in September 2006, the lnstitute of Medicine recommended that the Food and Drug Administration develop and continually improve a systematic approach to benefit:risk analysis, while in December 2006, the European Committee for Proprietary Medicinal Products called for improved methodolo-

gy leading to a more systematic approach for benefit:risk analyses. The major impedances of methodological development for benefit:risk analysis are the complexity of the challenges. These challenges include the development of a metric to characterize both benefits and risks so that a proper comparison can be made, the subjective weighting of the benefits and risks, the assessment of causality, the temporal difference between development of benefits and development of harms and the duration of the studies that are designed to detect them, the disease-specific interpretation of the assessment, the constantly changing options of alternative medications, and how to incorporate non-trial-based evidence. Indeed, benefit:risk analyses require much critical thought. Despite these challenges, quantitative approaches to the assessment of benefit:risk have been proposed in the literature. This special section of the Drug Information Journal includes "Measures for Conducting Comparative Benefit:Risk Assessment" by Chuang-Stein, Entsuah, and Pritchett. who also suggest opportunities for future research on benefit:risk analyses. ONeill authored "A Perspective on Characterizing Benefits and Risks Derived From Clinical Trials" and asks, "Can we do more?" O'Neill answers affrmatively and suggests approaches to improve the assessment of benefit:risk.

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