Advanced search
Publication Cover
Accountability in Research
Ethics, Integrity and Policy
Volume 15, 2008 - Issue 3
Submit an article Journal homepage
162
Views
14
CrossRef citations to date
0
Altmetric
Original Articles

Clinical Trials of Drugs Used Off-Label in Neonates: Ethical Issues and Alternative Study Designs

Sanjiv B. Amin MBBSM.D. Department of Pediatrics, University of Rochester School of Medicine, Rochester, New York, USACorrespondence[email protected]
,
Michael P. McDermott Ph.D. Departments of Biostatistics and Computational Biology and Neurology, University of Rochester School of Medicine, Rochester, New York, USA
&
Adil E. Shamoo Ph.D.CIP Departments of Biochemistry and Molecular Biology and Epidemiology and Preventive Medicine, University of Maryland, School of Medicine, Baltimore, Maryland, USA
Pages 168-187 | Published online: 08 Jul 2008

Citations (14)

Keep up to date with the latest research on this topic with citation updates for this article.

Subscribe to citation updates

Read on this site (2)

Jing Liu, Xin-Xin Chen & Xin-Ling Wang. (2016) Ethical issues in neonatal intensive care units. The Journal of Maternal-Fetal & Neonatal Medicine 29:14, pages 2322-2326.
Read now
Steven E Kern. (2009) Challenges in conducting clinical trials in children: approaches for improving performance. Expert Review of Clinical Pharmacology 2:6, pages 609-617.
Read now

Articles from other publishers (12)

G. Benfatto, Laura Longo, Silvana Mansueto, Lucia Gozzo, Daniela C. Vitale, Salvatore Amato, Francesco Basile, Adele Blanco, Vito Borzì, Patrizia Cavallaro, Sonia Cilia, Mario Conti, Concetto Cristaudo, Letterio D. Daidone, Salvatore Di Fazzio, Maurizio Di Mauro, Rosaria Garozzo, Gaetano Giardina, Antonio Gulino, Liliana Iachelli, Maria L. La Bella, Agata La Rosa, Antonio Lazzara, Francesco Leonardi, Francesca Lo Monaco, Lorenzo Malatino, Teresa Mattina, Matteo Negro, Filippo Palermo, Stefano Puleo, Rosa Raciti, Martino Ruggieri, Antonio Sapuppo, Renato Scillieri, Sebastiano Squatrito, Francesco Tanasi & F. Drago. (2021) Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees. BMC Medical Ethics 22:1.
Crossref
Rebeccah Slater, Fiona Moultrie, Ralph Bax, John van den Anker & Aomesh Bhatt. (2020) Preterm health: time to bridge the evidence gap. The Lancet 396:10255, pages 872-873.
Crossref
Kamini Yadav & Elaine M. Boyle. 2020. Emerging Topics and Controversies in Neonatology. Emerging Topics and Controversies in Neonatology 559 571 .
Janet S. Soul, Ronit Pressler, Marilee Allen, Geraldine Boylan, Heike Rabe, Ron Portman, Pollyanna Hardy, Sarah Zohar, Klaus Romero, Brian Tseng, Varsha Bhatt-Mehta, Cecil Hahn, Scott Denne, Stephane Auvin, Alexander Vinks, John Lantos, Neil Marlow & Jonathan M. Davis. (2018) Recommendations for the design of therapeutic trials for neonatal seizures. Pediatric Research 85:7, pages 943-954.
Crossref
Mufiza Farid-Kapadia, Lisa Askie, Lisa Hartling, Despina Contopoulos-Ioannidis, Zulfiqar A. Bhutta, Roger Soll, David Moher & Martin Offringa. (2017) Do systematic reviews on pediatric topics need special methodological considerations?. BMC Pediatrics 17:1.
Crossref
Jou-Ku Chung, Boubou Hallberg, Ingrid Hansen-Pupp, Martin A. Graham, Gerald Fetterly, Jyoti Sharma, Adina Tocoian, Nerissa C. Kreher, Norman Barton, Ann Hellström & David Ley. (2016) Development and verification of a pharmacokinetic model to optimize physiologic replacement of rhIGF-1/rhIGFBP-3 in preterm infants. Pediatric Research 81:3, pages 504-510.
Crossref
Christopher Megone, Eleanor Wilman, Sandy Oliver, Lelia Duley, Gill Gyte & Judy Wright. (2016) The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research. Trials 17:1.
Crossref
April V. P. Clyburne-Sherin, Pravheen Thurairajah, Mufiza Z. Kapadia, Margaret Sampson, Winnie W. Y. Chan & Martin Offringa. (2015) Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews. Trials 16:1.
Crossref
S. Samiee-Zafarghandy, M. Mazer-Amirshahi & J. N. van den Anker. (2014) Trends in paediatric clinical pharmacology data in US pharmaceutical labelling. Archives of Disease in Childhood 99:9, pages 862-865.
Crossref
Nicola Laforgia, Melissa Maria Nuccio, Federico Schettini, Marisa Dell'Aera, Anna Rita Gasbarro, Alessandro Dell'Erba & Biagio Solarino. (2014) Off-label and unlicensed drug use among neonatal intensive care units in Southern Italy. Pediatrics International 56:1, pages 57-59.
Crossref
Christopher F. Hyer. (2010) Off-Label Use and Prescribing What Does It Mean for the Foot and Ankle Surgeon?. Foot & Ankle Specialist 3:5, pages 303-306.
Crossref
András Telekes. (2009) Off-label therapies in oncology. Orvosi Hetilap 150:8, pages 363-372.
Crossref

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.