临床研究方案设计中的几个常见问题和解决方法

2014-06-26 王小钦, 林果为, 张骏延中华内科杂志

科研设计决定了临床研究的质量和科研水平,没有严谨的设计,不但达不到预期的结果,还会产生错误的结论,误导临床医师和广大患者,也浪费宝贵的时间和科研经费,所以研究者在进行科研之前一定要花比较多的时间考虑科研设计问题,必须有完整的设计方案后再动手做研究,而不能“想到什么就做什么,做到哪步算哪步”。主要包括如下问题：（1）研究类型定义

科研设计决定了临床研究的质量和科研水平,没有严谨的设计,不但达不到预期的结果,还会产生错误的结论,误导临床医师和广大患者,也浪费宝贵的时间和科研经费,所以研究者在进行科研之前一定要花比较多的时间考虑科研设计问题,必须有完整的设计方案后再动手做研究,而不能“想到什么就做什么,做到哪步算哪步”。主要包括如下问题：（1）研究类型定义不清楚或错误（2）主要与次要终点定义不清晰（3）没有科学假设（4）没有对照，或对照不合理（5）名义上的随机对照研究（6）没有计算样本量原始出处：王小钦, 林果为, 张骏延. 临床研究方案设计中的几个常见问题和解决方法[J]. 中华内科杂志, 2014, 53(4): 262-264.

版权声明：
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料，版权均属于梅斯医学所有。非经授权，任何媒体、网站或个人不得转载，授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章，或“梅斯号”自媒体发布的文章，仅系出于传递更多信息之目的，本站仅负责审核内容合规，其内容不代表本站立场，本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系，我们将立即进行删除处理。
在此留言

评论区 (6)

#插入话题

插入图片

[GetPortalCommentsPageByObjectIdResponse(id=2016215, encodeId=758a201621532, content=<a href='/topic/show?id=5fc458e751c' target=_blank style='color:#2F92EE;'>#方案设计#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58775, encryptionId=5fc458e751c, topicName=方案设计)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3860283, createdName=whmdzju, createdTime=Sun Oct 26 08:54:00 CST 2014, time=2014-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1688738, encodeId=7ecd1688e38ed, content=<a href='/topic/show?id=c011e3406a8' target=_blank style='color:#2F92EE;'>#研究方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73406, encryptionId=c011e3406a8, topicName=研究方案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=13f028628303, createdName=ms8543593053280928, createdTime=Wed Jul 30 23:54:00 CST 2014, time=2014-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10866, encodeId=0e5310866c8, content=图总结得很清晰, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=69bd13185, createdName=hygeia1019, createdTime=Tue Aug 05 11:49:00 CST 2014, time=2014-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10554, encodeId=3dab1055468, content=样本量怎么计算呢？, beContent=null, objectType=article, channel=null, level=null, likeNumber=129, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=51b9105133, createdName=qing1231990, createdTime=Mon Jul 21 01:26:00 CST 2014, time=2014-07-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10487, encodeId=e4c61048e45, content=有无干预，是否随机，有无对照, beContent=null, objectType=article, channel=null, level=null, likeNumber=145, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d2d2103784, createdName=chen111111, createdTime=Tue Jul 15 23:12:00 CST 2014, time=2014-07-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1374240, encodeId=cb3a13e424010, content=<a href='/topic/show?id=8671486541a' target=_blank style='color:#2F92EE;'>#常见问题#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48654, encryptionId=8671486541a, topicName=常见问题)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5e30378, createdName=caobinglei8079, createdTime=Sat Jun 28 10:54:00 CST 2014, time=2014-06-28, status=1, ipAttribution=)]
2014-10-26 whmdzju

#方案设计#

68 0
[GetPortalCommentsPageByObjectIdResponse(id=2016215, encodeId=758a201621532, content=<a href='/topic/show?id=5fc458e751c' target=_blank style='color:#2F92EE;'>#方案设计#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58775, encryptionId=5fc458e751c, topicName=方案设计)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3860283, createdName=whmdzju, createdTime=Sun Oct 26 08:54:00 CST 2014, time=2014-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1688738, encodeId=7ecd1688e38ed, content=<a href='/topic/show?id=c011e3406a8' target=_blank style='color:#2F92EE;'>#研究方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73406, encryptionId=c011e3406a8, topicName=研究方案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=13f028628303, createdName=ms8543593053280928, createdTime=Wed Jul 30 23:54:00 CST 2014, time=2014-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10866, encodeId=0e5310866c8, content=图总结得很清晰, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=69bd13185, createdName=hygeia1019, createdTime=Tue Aug 05 11:49:00 CST 2014, time=2014-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10554, encodeId=3dab1055468, content=样本量怎么计算呢？, beContent=null, objectType=article, channel=null, level=null, likeNumber=129, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=51b9105133, createdName=qing1231990, createdTime=Mon Jul 21 01:26:00 CST 2014, time=2014-07-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10487, encodeId=e4c61048e45, content=有无干预，是否随机，有无对照, beContent=null, objectType=article, channel=null, level=null, likeNumber=145, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d2d2103784, createdName=chen111111, createdTime=Tue Jul 15 23:12:00 CST 2014, time=2014-07-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1374240, encodeId=cb3a13e424010, content=<a href='/topic/show?id=8671486541a' target=_blank style='color:#2F92EE;'>#常见问题#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48654, encryptionId=8671486541a, topicName=常见问题)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5e30378, createdName=caobinglei8079, createdTime=Sat Jun 28 10:54:00 CST 2014, time=2014-06-28, status=1, ipAttribution=)]
2014-07-30 ms8543593053280928

#研究方案#

68 0
[GetPortalCommentsPageByObjectIdResponse(id=2016215, encodeId=758a201621532, content=<a href='/topic/show?id=5fc458e751c' target=_blank style='color:#2F92EE;'>#方案设计#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58775, encryptionId=5fc458e751c, topicName=方案设计)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3860283, createdName=whmdzju, createdTime=Sun Oct 26 08:54:00 CST 2014, time=2014-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1688738, encodeId=7ecd1688e38ed, content=<a href='/topic/show?id=c011e3406a8' target=_blank style='color:#2F92EE;'>#研究方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73406, encryptionId=c011e3406a8, topicName=研究方案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=13f028628303, createdName=ms8543593053280928, createdTime=Wed Jul 30 23:54:00 CST 2014, time=2014-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10866, encodeId=0e5310866c8, content=图总结得很清晰, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=69bd13185, createdName=hygeia1019, createdTime=Tue Aug 05 11:49:00 CST 2014, time=2014-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10554, encodeId=3dab1055468, content=样本量怎么计算呢？, beContent=null, objectType=article, channel=null, level=null, likeNumber=129, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=51b9105133, createdName=qing1231990, createdTime=Mon Jul 21 01:26:00 CST 2014, time=2014-07-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10487, encodeId=e4c61048e45, content=有无干预，是否随机，有无对照, beContent=null, objectType=article, channel=null, level=null, likeNumber=145, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d2d2103784, createdName=chen111111, createdTime=Tue Jul 15 23:12:00 CST 2014, time=2014-07-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1374240, encodeId=cb3a13e424010, content=<a href='/topic/show?id=8671486541a' target=_blank style='color:#2F92EE;'>#常见问题#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48654, encryptionId=8671486541a, topicName=常见问题)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5e30378, createdName=caobinglei8079, createdTime=Sat Jun 28 10:54:00 CST 2014, time=2014-06-28, status=1, ipAttribution=)]
2014-08-05 hygeia1019

图总结得很清晰

95 0
[GetPortalCommentsPageByObjectIdResponse(id=2016215, encodeId=758a201621532, content=<a href='/topic/show?id=5fc458e751c' target=_blank style='color:#2F92EE;'>#方案设计#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58775, encryptionId=5fc458e751c, topicName=方案设计)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3860283, createdName=whmdzju, createdTime=Sun Oct 26 08:54:00 CST 2014, time=2014-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1688738, encodeId=7ecd1688e38ed, content=<a href='/topic/show?id=c011e3406a8' target=_blank style='color:#2F92EE;'>#研究方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73406, encryptionId=c011e3406a8, topicName=研究方案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=13f028628303, createdName=ms8543593053280928, createdTime=Wed Jul 30 23:54:00 CST 2014, time=2014-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10866, encodeId=0e5310866c8, content=图总结得很清晰, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=69bd13185, createdName=hygeia1019, createdTime=Tue Aug 05 11:49:00 CST 2014, time=2014-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10554, encodeId=3dab1055468, content=样本量怎么计算呢？, beContent=null, objectType=article, channel=null, level=null, likeNumber=129, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=51b9105133, createdName=qing1231990, createdTime=Mon Jul 21 01:26:00 CST 2014, time=2014-07-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10487, encodeId=e4c61048e45, content=有无干预，是否随机，有无对照, beContent=null, objectType=article, channel=null, level=null, likeNumber=145, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d2d2103784, createdName=chen111111, createdTime=Tue Jul 15 23:12:00 CST 2014, time=2014-07-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1374240, encodeId=cb3a13e424010, content=<a href='/topic/show?id=8671486541a' target=_blank style='color:#2F92EE;'>#常见问题#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48654, encryptionId=8671486541a, topicName=常见问题)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5e30378, createdName=caobinglei8079, createdTime=Sat Jun 28 10:54:00 CST 2014, time=2014-06-28, status=1, ipAttribution=)]
2014-07-21 qing1231990

样本量怎么计算呢？

129 0
[GetPortalCommentsPageByObjectIdResponse(id=2016215, encodeId=758a201621532, content=<a href='/topic/show?id=5fc458e751c' target=_blank style='color:#2F92EE;'>#方案设计#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58775, encryptionId=5fc458e751c, topicName=方案设计)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3860283, createdName=whmdzju, createdTime=Sun Oct 26 08:54:00 CST 2014, time=2014-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1688738, encodeId=7ecd1688e38ed, content=<a href='/topic/show?id=c011e3406a8' target=_blank style='color:#2F92EE;'>#研究方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73406, encryptionId=c011e3406a8, topicName=研究方案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=13f028628303, createdName=ms8543593053280928, createdTime=Wed Jul 30 23:54:00 CST 2014, time=2014-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10866, encodeId=0e5310866c8, content=图总结得很清晰, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=69bd13185, createdName=hygeia1019, createdTime=Tue Aug 05 11:49:00 CST 2014, time=2014-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10554, encodeId=3dab1055468, content=样本量怎么计算呢？, beContent=null, objectType=article, channel=null, level=null, likeNumber=129, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=51b9105133, createdName=qing1231990, createdTime=Mon Jul 21 01:26:00 CST 2014, time=2014-07-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10487, encodeId=e4c61048e45, content=有无干预，是否随机，有无对照, beContent=null, objectType=article, channel=null, level=null, likeNumber=145, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d2d2103784, createdName=chen111111, createdTime=Tue Jul 15 23:12:00 CST 2014, time=2014-07-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1374240, encodeId=cb3a13e424010, content=<a href='/topic/show?id=8671486541a' target=_blank style='color:#2F92EE;'>#常见问题#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48654, encryptionId=8671486541a, topicName=常见问题)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5e30378, createdName=caobinglei8079, createdTime=Sat Jun 28 10:54:00 CST 2014, time=2014-06-28, status=1, ipAttribution=)]
2014-07-15 chen111111

有无干预，是否随机，有无对照

145 0
[GetPortalCommentsPageByObjectIdResponse(id=2016215, encodeId=758a201621532, content=<a href='/topic/show?id=5fc458e751c' target=_blank style='color:#2F92EE;'>#方案设计#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58775, encryptionId=5fc458e751c, topicName=方案设计)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3860283, createdName=whmdzju, createdTime=Sun Oct 26 08:54:00 CST 2014, time=2014-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1688738, encodeId=7ecd1688e38ed, content=<a href='/topic/show?id=c011e3406a8' target=_blank style='color:#2F92EE;'>#研究方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73406, encryptionId=c011e3406a8, topicName=研究方案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=13f028628303, createdName=ms8543593053280928, createdTime=Wed Jul 30 23:54:00 CST 2014, time=2014-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10866, encodeId=0e5310866c8, content=图总结得很清晰, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=69bd13185, createdName=hygeia1019, createdTime=Tue Aug 05 11:49:00 CST 2014, time=2014-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10554, encodeId=3dab1055468, content=样本量怎么计算呢？, beContent=null, objectType=article, channel=null, level=null, likeNumber=129, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=51b9105133, createdName=qing1231990, createdTime=Mon Jul 21 01:26:00 CST 2014, time=2014-07-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=10487, encodeId=e4c61048e45, content=有无干预，是否随机，有无对照, beContent=null, objectType=article, channel=null, level=null, likeNumber=145, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d2d2103784, createdName=chen111111, createdTime=Tue Jul 15 23:12:00 CST 2014, time=2014-07-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1374240, encodeId=cb3a13e424010, content=<a href='/topic/show?id=8671486541a' target=_blank style='color:#2F92EE;'>#常见问题#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48654, encryptionId=8671486541a, topicName=常见问题)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5e30378, createdName=caobinglei8079, createdTime=Sat Jun 28 10:54:00 CST 2014, time=2014-06-28, status=1, ipAttribution=)]
2014-06-28 caobinglei8079

#常见问题#

56 0

内科

外科

专科科室

热点

按科室浏览

临床工具

科研工具

其他工具

科研数智化

真实世界研究解决方案

数字化学术传播解决方案

其它

研究设计与统计

临床研究方案设计中的几个常见问题和解决方法

相关资讯

科室

工具

服务

研究设计与统计

临床研究方案设计中的几个常见问题和解决方法

相关资讯

药品II期临床研究方案格式

临床研究过程中方案的校正情况分析

科室

工具

服务