Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceuticals: An IOM Workshop

项目摘要 人们越来越注意到需要加强对联合国系统的评价和沟通 与药品相关的益处和风险，从而增加了可预测性， 提高药品监管决策的透明度和效率。根据ITS 《处方药使用费法案》(PDUFA V)第五次授权下的承诺， FDA必须召开两次公开研讨会，解决重要的考虑因素，来自 监管机构对收益-风险评估的观点。对于第一个研讨会，FDA已经确定了一个 产生洞察力的重要机会，可以推动更有条理的发展 促进不确定性的表征、评估和沟通的方法 产生于对收益和风险的评估。应FDA的要求，美国食品和药物管理局的一个特设委员会 医学研究所(IOM)计划并在FDA的 White Oak设施，探索系统和结构化的方法来表征和 通报(A)效益和风险评估中的不确定性来源；和(B)其 对药品监管决策的影响。

Project Summary There is increasing attention to the need for enhancing the evaluation and communication of the benefits and risks associated with pharmaceutical products, thereby increasing the predictability, transparency and efficiency of pharmaceutical regulatory decision-making. Pursuant to its commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), FDA must convene two public workshops that address important considerations, from the regulator's perspective, on benefit-risk assessment. For the first workshop, FDA has identified an important opportunity to generate insight that can advance the development of more structured approaches to facilitate the characterization, evaluation and communication of uncertainty that arises in the assessment of benefits and risks. At the request of FDA, an ad hoc committee of the Institute of Medicine (IOM) planned and conducted two one-day public workshops at FDA's White Oak facility to explore systematic and structured approaches to characterize and communicate (a) the sources of uncertainty in the assessment of benefits and risks; and (b) their implications for pharmaceutical regulatory decisions.