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2
Real-World Evidence for Assessing Treatment Effectiveness and Safety in Pediatric Populations.评估儿科人群治疗有效性和安全性的真实世界证据。
J Pediatr. 2021 Nov;238:312-316. doi: 10.1016/j.jpeds.2021.06.062. Epub 2021 Jul 2.
3
A call to action: Issuing a diversity and inclusion challenge to research organizations.行动呼吁:向研究组织发出多样性和包容性挑战。
Clin Transl Sci. 2021 Nov;14(6):2095-2098. doi: 10.1111/cts.13105. Epub 2021 Jul 26.
4
Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance.利益相关者对单一 IRB 审查流程的体验以及对食品和药物管理局指导意见的建议。
Ethics Hum Res. 2021 May;43(3):26-36. doi: 10.1002/eahr.500092.
5
Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial.在家中开展临床试验:一项直接面向家庭的儿科狼疮试验的方案、设计和实施。
Lupus Sci Med. 2021 May;8(1). doi: 10.1136/lupus-2021-000494.
6
Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review.使用与美国和欧洲监管批准申请中外部对照进行比较的非随机研究的特征:系统评价。
BMJ Open. 2019 Feb 27;9(2):e024895. doi: 10.1136/bmjopen-2018-024895.
7
Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic?真实世界证据:被标记为实用的随机对照试验有多么实用?
BMC Med. 2018 Apr 3;16(1):49. doi: 10.1186/s12916-018-1038-2.
8
High-Quality Randomized Controlled Trials in Pediatric Critical Care: A Survey of Barriers and Facilitators.儿科重症监护领域的高质量随机对照试验:障碍与促进因素调查
Pediatr Crit Care Med. 2017 May;18(5):405-413. doi: 10.1097/PCC.0000000000001144.
9
Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience.优化早期试验中的运营效率:儿科试验网络的经验。
Contemp Clin Trials. 2016 Mar;47:376-82. doi: 10.1016/j.cct.2016.03.002. Epub 2016 Mar 9.
10
Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants: a randomized clinical trial.氟康唑预防对早产儿念珠菌病和死亡率的影响:一项随机临床试验。
JAMA. 2014 May 7;311(17):1742-9. doi: 10.1001/jama.2014.2624.

An Innovative Approach to Building an Effective and Efficient Pediatric Trial Network.

作者信息

Randell Rachel L, Benjamin Daniel K, Greenberg Rachel G

机构信息

Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.

Duke Clinical Research Institute, Durham, North Carolina.

出版信息

Hosp Pediatr. 2022 Sep 1;12(9):e309-e311. doi: 10.1542/hpeds.2022-006811.

DOI:10.1542/hpeds.2022-006811
PMID:35989348
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9558054/
Abstract
摘要