Disease modification in osteoarthritis; pathways to drug approval.
Disease modification in osteoarthritis; pathways to drug approval.
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DOI：
10.1016/j.ocarto.2020.100059
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发表时间：
2020-06
期刊：
影响因子：
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通讯作者：
Hochberg, Marc C
中科院分区：
文献类型：
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作者：
Katz, Jeffrey N;Neogi, Tuhina;Callahan, Leigh F;Block, Joel A;Conaghan, Philip G;Simon, Lee S;Kraus, Virginia Byers;Hochberg, Marc C
总结一个召集的研讨会的诉讼，以讨论改变骨关节炎（OA）药物的进展以及将这些药物推向市场的监管挑战。
2019年5月在华盛顿特区举行的为期一天的研讨会的摘要。
与会者介绍了有关OA的患病率，成本和残疾负担的数据；疾病修饰的最新记录在没有临床临床益处的疾病试验中，疾病修饰药物的临床益处；与疾病修饰疗法有关的监管注意事项；以及解决这些法规考虑因素的方法论方法。
这项研究，药物和监管群落必须继续合作定义批准修改骨关节炎药物的途径，以记录对临床终点（例如疼痛，功能或关节置换）以及骨骼，软骨和其他结构的影响。
To summarize proceedings of a workshop convened to discuss advances in disease modifying osteoarthritis (OA) drugs and regulatory challenges in bringing these drugs to market. Summary of a one day workshop held in Washington, DC in May 2019. Attendees presented data documenting the prevalence, cost and disability burden of OA; recent documentation of disease modification without concomitant clinical benefit in trials of disease modifying drugs; regulatory considerations pertinent to disease modifying therapy; and methodologic approaches to addressing these regulatory considerations. The research, pharmaceutical and regulatory communities must continue to collaborate on defining pathways for approval of disease modifying osteoarthritis drugs that document effects on clinical endpoints (such as pain, function or joint replacement) as well as on bone, cartilage and other structures.