The Use of Real-world Data to Generate Real-world Evidence to Accelerate Neonatal Drug Development

被引：0

作者：

Jackson, Shawn S. ^{[1
]}

Cravero, Joseph P. ^{[1
]}

Sun, Lena ^{[4
]}

Davis, Jonathan M. ^{[2
,3
]}

机构：

[1] Harvard Med Sch, Dept Anesthesiol Crit Care & Pain Med, Boston Childrens Hosp, Boston, MA 02115 USA

[2] Tufts Med Ctr, Dept Pediat, Boston, MA USA

[3] Tufts Univ, Tufts Clin & Translat Sci Inst, Dept Pediat, Div Newborn Med, Boston, MA USA

[4] Columbia Univ, Irving Med Ctr, Dept Anesthesiol, New York, NY 10032 USA

来源：

JOURNAL OF NEUROSURGICAL ANESTHESIOLOGY | 2025年 / 37卷 / 01期

关键词：

D O I：

10.1097/ANA.0000000000000989

中图分类号：

R614 [麻醉学];

学科分类号：

100217 ;

摘要：

引用

页码：110 / 113

页数：4

共 16 条

[1] Serum creatinine concentration in very-low-birth-weight infants from birth to 34-36wk postmenstrual age [J].

Bateman, David A. ;

Thomas, William ;

Parravicini, Elvira ;

Polesana, Elena ;

Locatelli, Chiara ;

Lorenz, John M. .

PEDIATRIC RESEARCH, 2015, 77 (05) :696-702

[2] BPD Following Preterm Birth: A Model for Chronic Lung Disease and a Substrate for ARDS in Childhood [J].

Bhandari, Anita ;

Carroll, Christopher ;

Bhandari, Vineet .

FRONTIERS IN PEDIATRICS, 2016, 4

[3] Effect of Early vs Late Inguinal Hernia Repair on Serious Adverse Event Rates in Preterm Infants: A Randomized Clinical Trial [J].

Blakely, Martin L. ;

Krzyzaniak, Andrea ;

Dassinger, Melvin S. ;

Pedroza, Claudia ;

Weitkamp, Jorn-Hendrik ;

Gosain, Ankush ;

Cotten, Michael ;

Hintz, Susan R. ;

Rice, Henry ;

Courtney, Sherry E. ;

Lally, Kevin P. ;

Ambalavanan, Namasivayam ;

Bendel, Catherine M. ;

Bui, Kim Chi T. ;

Calkins, Casey ;

Chandler, Nicole M. ;

Dasgupta, Roshni ;

Davis, Jonathan M. ;

Deans, Katherine ;

Deugarte, Daniel A. ;

Gander, Jeffrey ;

Jackson, Carl-Christian A. ;

Keszler, Martin ;

Kling, Karen ;

Fenton, Stephen J. ;

Fisher, Kimberley A. ;

Hartman, Tyler ;

Huang, Eunice Y. ;

Islam, Saleem ;

Koch, Frances ;

Lainwala, Shabnam ;

Lesher, Aaron ;

Lopez, Monica ;

Misra, Meghna ;

Overbey, Jamie ;

Poindexter, Brenda ;

Russell, Robert ;

Stylianos, Steven ;

Tamura, Douglas Y. ;

Yoder, Bradley A. ;

Lucas, Donald ;

Shaul, Donald ;

Ben Ham III, P. ;

Fitzpatrick, Colleen ;

Calkins, Kara ;

Garrison, Aaron ;

de la Cruz, Diomel ;

Abdessalam, Shahab ;

Kvasnovsky, Charlotte ;

Segura, Bradley J. .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2024, 331 (12) :1035-1044

[4]

CfDEa Research, 2023, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products

[5] Applications of artificial intelligence in drug development using real-world data [J].

Chen, Zhaoyi ;

Liu, Xiong ;

Hogan, William ;

Shenkman, Elizabeth ;

Bian, Jiang .

DRUG DISCOVERY TODAY, 2021, 26 (05) :1256-1264

[6] Sharing Data to Accelerate Medicine Development and Improve Neonatal Care: Data Standards and Harmonized Definitions [J].

Costeloe, Kate ;

Turner, Mark A. ;

Padula, Michael A. ;

Shah, Prakesh S. ;

Modi, Neena ;

Soll, Roger ;

Haumont, Dominique ;

Kusuda, Satoshi ;

Goepel, Wolfgang ;

Chang, Yun Sil ;

Smith, P. Brian ;

Lui, Kei ;

Davis, Jonathan M. ;

Hudson, Lynn D. .

JOURNAL OF PEDIATRICS, 2018, 203 :437-+

[7] Use of Dexmedetomidine and Opioids in Hospitalized Preterm Infants [J].

Curtis, Samantha ;

Kilpatrick, Ryan ;

Billimoria, Zeenia C. ;

Zimmerman, Kanecia ;

Tolia, Veeral ;

Clark, Reese ;

Greenberg, Rachel G. ;

Puia-Dumitrescu, Mihai .

JAMA NETWORK OPEN, 2023, 6 (11) :E2341033

[8] Global Collaboration to Develop New and Existing Drugs for Neonates [J].

Davis, Jonathan M. ;

Turner, Mark A. .

JAMA PEDIATRICS, 2015, 169 (10) :887-888

[9]

Food and Drug Administration, 1999, Precedex (Dexmedetomidine Hydrochloride)

[10]

Gunja M. Z., 2023, U.S. health care from a global perspective, 2022: Accelerating spending, worsening outcomes

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