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首页> 外文期刊>Osteoarthritis and cartilage >Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs
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Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs

机译：根据代理终点的批准和促销FDA加速审批法规的批准批准的批准研究设计，用于修饰骨关节炎药物的加速批准规定

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摘要

In 1992, the Food and Drug Administration (FDA) instituted the accelerated approval regulations that allow drugs or biologics for serious conditions that fill an unmet medical need to be approved on the basis of a surrogate endpoint or an intermediate clinical endpoint. The current definition of a serious condition includes chronic disabling conditions, such as osteoarthritis (OA), and thereby provides expanded opportunities for the use of biomarkers for regulatory approval of drugs for OA. The use of surrogates or intermediate clinical endpoints for initial regulatory approval of a drug or biologic requires confirmation in a post-marketing study of a drug effect on a clinically relevant outcome, such as on how a patient feels, functions or survives. Current FDA guidance requires that the post-marketing approval (PMA) study be ongoing during the time of initial drug approval. This white paper arose out of the need to brainstorm trial designs that might be suitable for PMA of drugs initially approved, on the basis of a surrogate or intermediate clinical endpoint, for treatment of OA to alter disease progression, abnormal function or pathological changes in the morphology of the joint. In this white paper we define the concept and regulations regarding accelerated approval and propose two major study design scenarios for PMA trials in OA. The long-term goal is to discuss and refine these designs in consultation with regulatory agencies in order to facilitate development of drugs to fill the large unmet need in OA. (c) 2018 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
机译：1992年，食品和药物管理局（FDA）制定了加速批准规定，允许根据代理终点或中间临床终点批准填补未满足医疗的严重条件的药物或生物学。严重状况的目前的定义包括慢性致残条件，例如骨关节炎（OA），从而为使用生物标志物提供扩展机会，以便对OA药物的药物进行监管批准。使用替代物或中间临床终点用于药物或生物学的初始调节批准需要确认在临床相关结果对药物影响的营销后的研究中，例如患者如何感受，功能或存活。目前的FDA指导要求在初始药物批准期间正在进行营销后批准（PMA）研究。这篇白皮书出现了在替代或中间临床终点的基础上突发出脑风暴试验设计，这些试验设计可能适用于初步批准的药物PMA，用于治疗OA以改变疾病进展，异常功能或病理变化联合的形态。在这篇白纸中，我们界定了关于加速批准的概念和规定，并提出了两项​​主要研究设计方案在OA中的PMA试验。长期目标是与监管机构协商讨论和改进这些设计，以促进毒品的发展，以填补OA的大量未满足。 （c）2018年骨关节炎研究协会国际。 elsevier有限公司出版。保留所有权利。

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