Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials
Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials
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DOI：
10.1093/cid/ciw668
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发表时间：
2017-01-01
影响因子：
11.8
通讯作者：
Griffiths, Paul D.
中科院分区：
文献类型：
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作者：
Ljungman, Per;Boeckh, Michael;Griffiths, Paul D.
巨细胞病毒（CMV）感染和疾病是移植受者发病和死亡的重要原因。为了在临床试验中形成一致的 CMV 结果报告，制定了 CMV 感染和疾病的定义，并于 2002 年最新发布。此后，其诊断和管理取得了重大进展。因此，由科学家、临床医生、监管机构和行业代表组成的 CMV 药物开发论坛制作了一个包含最新知识的更新版本，旨在支持临床研究和药物开发。与之前的定义相比，主要变化是引入了“可能疾病”类别，并将定量核酸检测纳入一些终末器官疾病类别。随着该领域的发展，更新这些定义的需求是显而易见的，科学家、监管机构和行业之间的合作可以为这项工作提供一个平台。
Cytomegalovirus (CMV) infection and disease are important causes of morbidity and mortality in transplant recipients. For the purpose of developing consistent reporting of CMV outcomes in clinical trials, definitions of CMV infection and disease were developed and most recently published in 2002. Since then, there have been major developments in its diagnosis and management. Therefore, the CMV Drug Development Forum consisting of scientists, clinicians, regulators, and industry representatives has produced an updated version incorporating recent knowledge with the aimto support clinical research and drug development. The main changes compared to previous definitions are the introduction of a "probable disease" category and to incorporate quantitative nucleic acid testing in some end-organ disease categories. As the field evolves, the need for updates of these definitions is clear, and collaborative efforts between scientists, regulators, and industry can provide a platform for this work.