Harnessing the Power of Real-World Evidence (RWE): A Checklist to Ensure Regulatory-Grade Data Quality.

Harnessing the Power of Real-World Evidence (RWE): A Checklist to Ensure Regulatory-Grade Data Quality.
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DOI:
10.1002/cpt.946
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发表时间:
2018-03
影响因子:
6.7
通讯作者:
Abernethy AP
Abernethy AP
中科院分区:
医学2区
文献类型:
--
作者:
Miksad RA;Abernethy AP

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真实的世界证据(RWE)在监管、药物开发和医疗决策中的作用正在迅速扩大。最近的进展增加了癌症护理的复杂性,并扩大了随机临床试验(RCT)结果与真实的世界临床决策所需证据之间的差距。1来自95%以上在临床试验之外接受治疗的癌症患者的数据可以帮助填补这一空白,而不是保持无形。
The role of real‐world evidence (RWE) in regulatory, drug development, and healthcare decision‐making is rapidly expanding. Recent advances have increased the complexity of cancer care and widened the gap between randomized clinical trial (RCT) results and the evidence needed for real‐world clinical decisions.1 Instead of remaining invisible, data from the >95% of cancer patients treated outside of clinical trials can help fill this void.
DOI: 10.2217/fon-2015-0043
发表时间: 2016-01-01
期刊: FUTURE ONCOLOGY
影响因子: 3.3
作者:
Berger, Marc L.;Curtis, Melissa D.;Abernethy, Amy P.
通讯作者: Abernethy, Amy P.