移植人群中 CMV 疾病治疗和预防治疗药物的开发：监管视角。
The Development of Therapeutics for the Treatment and Prevention of CMV Disease in the Transplant Population: A Regulatory Perspective.
机构信息
Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Infectious Diseases, Division of Antiviral, Silver Spring, Maryland.
出版信息
J Infect Dis. 2020 Mar 5;221(Suppl 1):S109-S112. doi: 10.1093/infdis/jiz389.
Abstract
Cytomegalovirus (CMV) remains an important pathogen in the transplant population. As such, the US Food and Drug Administration has published a guidance to encourage and inform the development of therapeutics for the treatment and prevention of CMV disease in this population. This review summarizes important phase 3 trial design considerations for industry and provides rationale for some of the recommendations included in the guidance.
摘要
巨细胞病毒（CMV）仍然是移植人群中的重要病原体。因此，美国食品和药物管理局发布了一份指南，以鼓励和告知治疗和预防该人群中 CMV 疾病的治疗方法的开发。本综述总结了行业重要的 3 期临床试验设计注意事项，并为指南中包含的一些建议提供了依据。
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