Real Life Outcomes vs. Clinical Trial Results
Real Life Outcomes vs. Clinical Trial Results
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DOI：
10.4103/jovr.jovr_279_18
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发表时间：
2019-01-01
影响因子：
2
通讯作者：
Zarbin, Marco
中科院分区：
文献类型：
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作者：
Zarbin, Marco
当临床医生试图将临床试验的结果应用于临床实践时，他们应该回答两个问题：（1）在他们的临床实践中是否会重现具有统计学意义的结果;（2）如果临床试验没有出错，一切都好吗？关于第一个问题，当考虑随机、多中心、前瞻性、对照临床试验的结果时，有两个问题不能通过简单地阅读试验结果来解决，只有执业临床医生才能回答：（1）研究人群是否代表即将接受治疗的患者;以及（2）试验外的所有证据（包括临床医生自身的丰富经验）是否与试验结果一致？关于第二个问题，建议临床医生认识到，大多数研究，即使是3期试验，也无法准确评估低频率事件的风险。
Two questions that clinicians should answer as they attempt to apply the results of clinical trials to clinical practice are: (1) will statistically significant results be reproduced in their clinical practice; and (2) if nothing goes wrong in a clinical trial, is everything alright? Regarding the first question, when considering the results of a randomized, multicenter, prospective, controlled clinical trial, two questions that cannot be addressed by simply by reading the trial results and that only the practicing clinician can answer are: (1) is the study population representative of the patient about to be treated; and (2) is the totality of evidence outside the trial (including the clinician's own extensive experience) consistent with the trial result? Regarding the second question, clinicians are advised to recognize that most studies, even Phase 3 trials, are underpowered to accurately assess the risk of low frequency events.