在下是临床大三学生，发一份作业给大家看。希望大家批评。是一篇关于NSCLC非小细胞肺癌化疗药物的三期临床试验。第一次做，请大家指点。这里版面所限，之发摘要了。具体内容一楼一楼的盖了。
研究申明
本实验保障实验过程中充分利用研究单位的医疗资源保护受试者生命健康和权益不受侵害。试验研究工作遵循科学和道德的原则，充分体现《赫尔辛基宣言》受试者权力和义务。
本实验遵守国家颁布的《药品临床试验管理规范》
《药物临床试验质量管理规范》
《药品注册管理办法》
《药物临床试验伦理审查工作指导原则》
本实验申办单位：XXXXXXXXXXXXX负责人：XXX检查员：XXX主要研究者：XXX 所在单位：XXXXXXXX 执行单位： 1.XX市XX医院2.XX市XXXX医院3.XX市第一人民医院4.XX市第二人民医院5.XX市第三人民医院6.YY市YY医院7.YY市YYY医院8.YY市第一人民医院9.YY市第二人民医院10.XXX医科大学附属医院 前言EML4-ALK基因融合性NSCLC。全称#####，上个世纪90年代即发现有耐药性NSCLC出现。发病率在非小细胞肺癌中大约为5~7%之间。进入本世纪后，确定其耐药性来源于EML4和ALK两组基因的融合。其对传统化疗所用的药物有明显的耐药性。产生预后不良。针对此类肺癌有ALK融合这一大特性，辉瑞公司研制出的新药Crizotinib（中文译名尚存争议，本文一律使用其英文原名）进过一二期临床试验后，确证其有治疗意义，效果明确。本实验意在进一步讨论此药的安全性和有效性，记录其不良事件，进行三期临床试验。为期上市提供有效的科学的实验数据支持，并完善其相关指标。
目录计划概要
1.申明/前言·····················································01
2.目录··························································02
3.摘要··························································03
4.缩略语表······················································04
5.试验流程图····················································05
计划正文
1.设计依据······················································06
2.实验背景······················································07
3.实验目的······················································07
4.实验设计······················································08
5.病例选择······················································09
6.治疗方案······················································11
7.观测项目及指标················································14
8.临床实验步骤··················································16
9.疗效和安全评定················································1710.质量控制和保证···············································18
11.不良事件观测·················································20
12.伦理原则·····················································22
13.数据管理·····················································22
14.统计分析·····················································23
15.偏倚和控制···················································24
16.各方承担职责和论文发表·······································2417.任务分配，预计进度···········································24
18.实验总结·····················································24
附录
1.知情同意书····················································25
2.试验药物说明书················································28
3.不良事件报告处理规程··········································31
4.应急信件······················································33
摘要
目的：本实验意在研究针对EML4-ALK非小细胞肺癌新靶向治疗药物Crizotinib的有效性和安全性进行评估。二．方法：本实验采用自身对照的双盲法多中心实验。简易流程如下
[img]file:///C:/Users/ADMINI~1/AppData/Local/Temp/msohtmlclip1/01/clip_image001.png[/img]
（一）受试者先应病理活检确诊为NSCLC。然后通过免疫组化、逆转录聚合酶链反应、荧光原位杂交，三者任何两者支持EML4-ALK融合即诊断为EML4-ALK融合型肺癌。进入受试者名录。（具体参见5.1诊断标准）但是，对不不适合参与此类实验的患者需要排除。具体参见5.2（纳入标准）和5.3（排除标准）。最后对入选病人进行评级（二）使用传统治疗法（泰素联合卡铂用药），Crizotinib的相似安慰剂进行治疗（为期4个月，也即一疗程）。结束时记录试验相关数据，对患者进行评级。（三）使用Crizotinib和传统药物的安慰剂（果糖注射液和生理盐水）进行治疗，（为期20个月，5个疗程）。没一个疗程记录一次相关数据，对患者状况进行一次评级。并记录不良反应。三．脱失：对于意外情况退出实验的受试者，尽量采集其最后一次病征和状况，记录进入档案。对于试验中死亡病人，也要尽量采集其相关数据，必要时劝服家属进行尸检。对于自愿退出者，也应采集最后一次数据，放自由退出。对于严重不良反应必需退出者应完成上述记录后，填写不良反应记录，并分级上报四．样本量：本实验通过计算，和国家爱法规要求，采用580人样本量。考虑到不同年龄并发症的不同，故依据年龄分为3个组，1组35岁以下。2组35~60岁。3组60岁以上。平均随机分配到10个实验定点医院内进行实验，每个医院形成自己的XX院-1、2、3组。 五．治疗疗效指标和安全指标：治疗效果分为三个指标评价。第一，CT计算肿瘤是否增大或者缩小。第二，依据病人现状对其肿瘤重新进行TNM分级。第三，综合生存状况评价。依据患者现状评价其生活质量和预计生存期。 安全指标主要确定在不良反应上，对不良反应进行分级，上报。对于严重不良反应需要停药，并追查原因，抢救治疗病人。必要时请病人退出实验。六．预期试验进度：本实验预计历时24个月，筛选病人预计需要4个月。现行筛选成功的病人可现行进行试验。最终记录的数据预计历时1个月可分析得出。全期历时30个月。七．数据分析：本实验采集数据为一个疗程采集一次（4个月一次）。主要为肿瘤大小的比较和疗效指数的比较。疗效指数=肿瘤减小的大小*50%+病人生活治疗改善*20%+预估5年生存几率*30%。 11 1 2 3 4 5 6 下一页 尾页
研究申明
本实验保障实验过程中充分利用研究单位的医疗资源保护受试者生命健康和权益不受侵害。试验研究工作遵循科学和道德的原则，充分体现《赫尔辛基宣言》受试者权力和义务。
本实验遵守国家颁布的《药品临床试验管理规范》
《药物临床试验质量管理规范》
《药品注册管理办法》
《药物临床试验伦理审查工作指导原则》
本实验申办单位：XXXXXXXXXXXXX负责人：XXX检查员：XXX主要研究者：XXX 所在单位：XXXXXXXX 执行单位： 1.XX市XX医院2.XX市XXXX医院3.XX市第一人民医院4.XX市第二人民医院5.XX市第三人民医院6.YY市YY医院7.YY市YYY医院8.YY市第一人民医院9.YY市第二人民医院10.XXX医科大学附属医院 前言EML4-ALK基因融合性NSCLC。全称#####，上个世纪90年代即发现有耐药性NSCLC出现。发病率在非小细胞肺癌中大约为5~7%之间。进入本世纪后，确定其耐药性来源于EML4和ALK两组基因的融合。其对传统化疗所用的药物有明显的耐药性。产生预后不良。针对此类肺癌有ALK融合这一大特性，辉瑞公司研制出的新药Crizotinib（中文译名尚存争议，本文一律使用其英文原名）进过一二期临床试验后，确证其有治疗意义，效果明确。本实验意在进一步讨论此药的安全性和有效性，记录其不良事件，进行三期临床试验。为期上市提供有效的科学的实验数据支持，并完善其相关指标。
目录计划概要
1.申明/前言·····················································01
2.目录··························································02
3.摘要··························································03
4.缩略语表······················································04
5.试验流程图····················································05
计划正文
1.设计依据······················································06
2.实验背景······················································07
3.实验目的······················································07
4.实验设计······················································08
5.病例选择······················································09
6.治疗方案······················································11
7.观测项目及指标················································14
8.临床实验步骤··················································16
9.疗效和安全评定················································1710.质量控制和保证···············································18
11.不良事件观测·················································20
12.伦理原则·····················································22
13.数据管理·····················································22
14.统计分析·····················································23
15.偏倚和控制···················································24
16.各方承担职责和论文发表·······································2417.任务分配，预计进度···········································24
18.实验总结·····················································24
附录
1.知情同意书····················································25
2.试验药物说明书················································28
3.不良事件报告处理规程··········································31
4.应急信件······················································33
摘要
目的：本实验意在研究针对EML4-ALK非小细胞肺癌新靶向治疗药物Crizotinib的有效性和安全性进行评估。二．方法：本实验采用自身对照的双盲法多中心实验。简易流程如下
[img]file:///C:/Users/ADMINI~1/AppData/Local/Temp/msohtmlclip1/01/clip_image001.png[/img]
（一）受试者先应病理活检确诊为NSCLC。然后通过免疫组化、逆转录聚合酶链反应、荧光原位杂交，三者任何两者支持EML4-ALK融合即诊断为EML4-ALK融合型肺癌。进入受试者名录。（具体参见5.1诊断标准）但是，对不不适合参与此类实验的患者需要排除。具体参见5.2（纳入标准）和5.3（排除标准）。最后对入选病人进行评级（二）使用传统治疗法（泰素联合卡铂用药），Crizotinib的相似安慰剂进行治疗（为期4个月，也即一疗程）。结束时记录试验相关数据，对患者进行评级。（三）使用Crizotinib和传统药物的安慰剂（果糖注射液和生理盐水）进行治疗，（为期20个月，5个疗程）。没一个疗程记录一次相关数据，对患者状况进行一次评级。并记录不良反应。三．脱失：对于意外情况退出实验的受试者，尽量采集其最后一次病征和状况，记录进入档案。对于试验中死亡病人，也要尽量采集其相关数据，必要时劝服家属进行尸检。对于自愿退出者，也应采集最后一次数据，放自由退出。对于严重不良反应必需退出者应完成上述记录后，填写不良反应记录，并分级上报四．样本量：本实验通过计算，和国家爱法规要求，采用580人样本量。考虑到不同年龄并发症的不同，故依据年龄分为3个组，1组35岁以下。2组35~60岁。3组60岁以上。平均随机分配到10个实验定点医院内进行实验，每个医院形成自己的XX院-1、2、3组。 五．治疗疗效指标和安全指标：治疗效果分为三个指标评价。第一，CT计算肿瘤是否增大或者缩小。第二，依据病人现状对其肿瘤重新进行TNM分级。第三，综合生存状况评价。依据患者现状评价其生活质量和预计生存期。 安全指标主要确定在不良反应上，对不良反应进行分级，上报。对于严重不良反应需要停药，并追查原因，抢救治疗病人。必要时请病人退出实验。六．预期试验进度：本实验预计历时24个月，筛选病人预计需要4个月。现行筛选成功的病人可现行进行试验。最终记录的数据预计历时1个月可分析得出。全期历时30个月。七．数据分析：本实验采集数据为一个疗程采集一次（4个月一次）。主要为肿瘤大小的比较和疗效指数的比较。疗效指数=肿瘤减小的大小*50%+病人生活治疗改善*20%+预估5年生存几率*30%。 11 1 2 3 4 5 6 下一页 尾页