试剂盒说明书中的参考值涉及不同的年龄分布，应怎样进行临床试验样本选择
2018-12-14
问：试剂盒说明书中的参考值涉及不同的年龄分布，应怎样进行临床试验样本选择？
答：临床试验设计过程中，纳入病例数除关注总体病例数、阳性和阴性病例数分布、干扰病例外，还应关注必要的病例分组、分层的需求。如试剂盒参考值在不同年龄段人群中有不同区间，在病例纳入时，应考虑不同年龄段人群的差异，分别纳入有统计学意义数量的不同年龄段人群，每个分段的人群中阳性和阴性病例比例应均衡。如参考值年龄分段较多，按照上述要求入组的总体病例数可能高于《体外诊断试剂临床试验技术指导原则》规定的最低样本量的要求。
业务咨询
客户意见反馈
▍成果概览#wz_data#[{"id":"smv_tem_246_30","type":"text","styleName":"Style1","colorName":"Item2","pageId":"50223","areaId":"Area3","tareaId":"Area3","parentId":"tem_256_51","parentAreaId":"Area0","Css":{"$StyleItemAndColor":"tem_246_30","$width":"92px","$color":"#000000","$animationName":"none","$duration":"0.75","$delay":"0.75","$direction":"","$infinite":"1","$height":"33px","zIndex":"2","width":82,"height":33,"offsetX":80,"offsetY":0,"foffsetX":"0","foffsetY":"0","fixedPosition":"None","useAnimate":"False","angle":"0","isFullScreen":"False","smlocked":"0","position":"absolute","themeColorName":"","themeColors":"zs1,zs2,zxs1,zxs2,zxs3,zxs4,zxs5"},"Data":{"IsShowTextNo":"false","TextNo":"00000","IsImportPage":"false","FontStyleData":"1","Target":"_self","LinkUrl":"","LinkType":"outsite","LinkValue":"","LinkValueText":"","Content":"%3Cp%3E%3Cspan%20style%3D%22font-size%3A16px%22%3E%3Cspan%20style%3D%22line-height%3A2%22%3E%3Cspan%20style%3D%22color%3A%2357c3d4%22%3E%3Cspan%20style%3D%22font-family%3ASource%20Han%20Sans%20CN%22%3E%3Cstrong%3E%E2%96%8D%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fspan%3E%3Cspan%20style%3D%22color%3A%23ffffff%22%3E%3Cspan%20style%3D%22font-family%3ASource%20Han%20Sans%20CN%22%3E%3Cstrong%3E%E6%96%B0%E9%97%BB%E4%B8%AD%E5%BF%83%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fspan%3E%3C%2Fspan%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A","CurrentItem":"null","ControlMode":"0","IsListModel":"false","ControlId":"tem_246_30","width":"82","height":"33"},"ExtData":{"smartViewAreaId":"Area3","smartParentViewAreaId":"Area0","parentControlId":"tem_256_51","parentControlType":"Scd.Plugin.Controls.SmartControls.AreaSmartControl"},"ListData":null,"x":80,"y":0,"children":[]}]#wz_data#[{"id":"smv_tem_246_30","type":"text","styleName":"Style1","colorName":"Item2","pageId":"50223","areaId":"Area3","tareaId":"Area3","parentId":"tem_256_51","parentAreaId":"Area0","Css":{"$StyleItemAndColor":"tem_246_30","$width":"92px","$color":"#000000","$animationName":"none","$duration":"0.75","$delay":"0.75","$direction":"","$infinite":"1","$height":"33px","zIndex":"2","width":82,"height":33,"offsetX":80,"offsetY":0,"foffsetX":"0","foffsetY":"0","fixedPosition":"None","useAnimate":"False","angle":"0","isFullScreen":"False","smlocked":"0","position":"absolute","themeColorName":"","themeColors":"zs1,zs2,zxs1,zxs2,zxs3,zxs4,zxs5"},"Data":{"IsShowTextNo":"false","TextNo":"00000","IsImportPage":"false","FontStyleData":"1","Target":"_self","LinkUrl":"","LinkType":"outsite","LinkValue":"","LinkValueText":"","Content":"%3Cp%3E%3Cspan%20style%3D%22font-size%3A16px%22%3E%3Cspan%20style%3D%22line-height%3A2%22%3E%3Cspan%20style%3D%22color%3A%2357c3d4%22%3E%3Cspan%20style%3D%22font-family%3ASource%20Han%20Sans%20CN%22%3E%3Cstrong%3E%E2%96%8D%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fspan%3E%3Cspan%20style%3D%22color%3A%23ffffff%22%3E%3Cspan%20style%3D%22font-family%3ASource%20Han%20Sans%20CN%22%3E%3Cstrong%3E%E6%96%B0%E9%97%BB%E4%B8%AD%E5%BF%83%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fspan%3E%3C%2Fspan%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A","CurrentItem":"null","ControlMode":"0","IsListModel":"false","ControlId":"tem_246_30","width":"82","height":"33"},"ExtData":{"smartViewAreaId":"Area3","smartParentViewAreaId":"Area0","parentControlId":"tem_256_51","parentControlType":"Scd.Plugin.Controls.SmartControls.AreaSmartControl"},"ListData":null,"x":80,"y":0,"children":[]}]#wz_data#[{"id":"smv_tem_246_30","type":"text","styleName":"Style1","colorName":"Item2","pageId":"50223","areaId":"Area3","tareaId":"Area3","parentId":"tem_256_51","parentAreaId":"Area0","Css":{"$StyleItemAndColor":"tem_246_30","$width":"92px","$color":"#000000","$animationName":"none","$duration":"0.75","$delay":"0.75","$direction":"","$infinite":"1","$height":"33px","zIndex":"2","width":82,"height":33,"offsetX":80,"offsetY":0,"foffsetX":"0","foffsetY":"0","fixedPosition":"None","useAnimate":"False","angle":"0","isFullScreen":"False","smlocked":"0","position":"absolute","themeColorName":"","themeColors":"zs1,zs2,zxs1,zxs2,zxs3,zxs4,zxs5"},"Data":{"IsShowTextNo":"false","TextNo":"00000","IsImportPage":"false","FontStyleData":"1","Target":"_self","LinkUrl":"","LinkType":"outsite","LinkValue":"","LinkValueText":"","Content":"%3Cp%3E%3Cspan%20style%3D%22font-size%3A16px%22%3E%3Cspan%20style%3D%22line-height%3A2%22%3E%3Cspan%20style%3D%22color%3A%2357c3d4%22%3E%3Cspan%20style%3D%22font-family%3ASource%20Han%20Sans%20CN%22%3E%3Cstrong%3E%E2%96%8D%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fspan%3E%3Cspan%20style%3D%22color%3A%23ffffff%22%3E%3Cspan%20style%3D%22font-family%3ASource%20Han%20Sans%20CN%22%3E%3Cstrong%3E%E6%96%B0%E9%97%BB%E4%B8%AD%E5%BF%83%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fspan%3E%3C%2Fspan%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A","CurrentItem":"null","ControlMode":"0","IsListModel":"false","ControlId":"tem_246_30","width":"82","height":"33"},"ExtData":{"smartViewAreaId":"Area3","smartParentViewAreaId":"Area0","parentControlId":"tem_256_51","parentControlType":"Scd.Plugin.Controls.SmartControls.AreaSmartControl"},"ListData":null,"x":80,"y":0,"children":[]}]
