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临床试验转化倡议：通过合作实现创新。

The Clinical Trials Transformation Initiative: innovation through collaboration.

机构信息

Clinical Trials Transformation Initiative, Duke Translational Medicine Institute, 300 West Morgan Street, Suite 800, Durham, North Carolina 27701, USA.

Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA.

出版信息

Nat Rev Drug Discov. 2014 Nov;13(11):797-8. doi: 10.1038/nrd4442.

DOI:10.1038/nrd4442
PMID:25359366
Abstract

The Clinical Trials Transformation Initiative (CTTI) identifies and promotes practices to increase the quality and efficiency of clinical trials through projects that generate empirical data on how trials are currently conducted, leading to recommendations for improvement.

摘要

临床试验转化倡议（CTTI）通过生成有关临床试验当前实施方式的经验数据的项目，确定并推广提高临床试验质量和效率的实践，并提出改进建议。

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PLoS One. 2013;8(1):e54999. doi: 10.1371/journal.pone.0054999. Epub 2013 Jan 30.
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The paradoxical problem with multiple-IRB review.多机构审查委员会审查中自相矛盾的问题。
N Engl J Med. 2010 Oct 21;363(17):1591-3. doi: 10.1056/NEJMp1005101. Epub 2010 Oct 13.
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Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.
Comput Struct Biotechnol J. 2023 Mar 16;21:2110-2118. doi: 10.1016/j.csbj.2023.03.014. eCollection 2023.
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Using the consolidated framework for implementation research to identify recruitment barriers and targeted strategies for a shared decision-making randomized clinical trial in pediatric sickle cell disease.利用实施研究综合框架识别小儿镰状细胞病共享决策随机临床试验的招募障碍和针对性策略。
Clin Trials. 2023 Jun;20(3):211-222. doi: 10.1177/17407745231154199. Epub 2023 Feb 16.
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Toward Modernization of Geriatric Oncology by Digital Health Technologies.通过数字健康技术推动老年肿瘤学现代化。
Am Soc Clin Oncol Educ Book. 2020 Mar;40:1-7. doi: 10.1200/EDBK_279505.
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Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol.英国癌症临床试验中患者报告结局方案内容及报告情况的评估：EPiC研究定性方案
BMJ Open. 2018 Feb 3;8(2):e017282. doi: 10.1136/bmjopen-2017-017282.
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Clinical trial design and recommendations: collectively, we can take them.临床试验设计和建议：我们可以共同接受它们。
Clin Exp Med. 2018 May;18(2):291-295. doi: 10.1007/s10238-017-0476-z. Epub 2017 Oct 13.
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Circulation. 2016 Mar 1;133(9):872-80. doi: 10.1161/CIRCULATIONAHA.115.019902.
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Cell Cycle. 2016;15(4):519-27. doi: 10.1080/15384101.2016.1138186.
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