137
Views
48
CrossRef citations to date
0
Altmetric
Perspective

Challenges in conducting clinical trials in children: approaches for improving performance

Pages 609-617 | Published online: 10 Jan 2014

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

Read on this site (2)

Douglas Fiebig. (2012) Preparing the Paediatric Investigation Plan application. Medical Writing 21:2, pages 108-113.
Read now
John van den Anker & Karel Allegaert. (2012) Clinical pharmacology in neonates and young infants: the benefit of a population-tailored approach. Expert Review of Clinical Pharmacology 5:1, pages 5-8.
Read now

Articles from other publishers (46)

Hlayiseka Mathevula, Natalie Schellack, Samuel Orubu, Brian Godman & Moliehi Matlala. (2023) Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications. Pharmacy 11:6, pages 174.
Crossref
Xiaoyun Yang, Kathi Williams, Rebecca Elliott, Martha Hokom, Janis Allen & Saloumeh K Fischer. (2023) Validation of low-volume sampling devices for pharmacokinetic analysis: technical and logistical challenges and solutions. Bioanalysis.
Crossref
Carmel Bogle, Steven D. Colan, Shelley D. Miyamoto, Swati Choudhry, Nathanya Baez-Hernandez, Molly M. Brickler, Brian Feingold, Ashwin K. Lal, Teresa M. Lee, Charles E. Canter & Steven E. Lipshultz. (2023) Treatment Strategies for Cardiomyopathy in Children: A Scientific Statement From the American Heart Association. Circulation 148:2, pages 174-195.
Crossref
Stella Pesiou, Rafel Barcelo, Marc Fradera, Ferran Torres & Caridad Pontes. (2023) Utilisation of drugs for the treatment of psychiatric diseases in the pediatric population: focus on off-label use. Frontiers in Pharmacology 14.
Crossref
Simone Lepage, Aislinn Conway, Noah Goodson, Paul Wicks, Laura Flight & Declan Devane. (2023) Online randomised trials with children: A scoping review. PLOS ONE 18:5, pages e0280965.
Crossref
Lin Bai, Yuqi Zhan, Yue Zhou, Yichen Zhang, Luwen Shi, Sumit Gupta, Avram Denburg & Xiaodong Guan. (2023) Evidence of clinical benefit of WHO essential anticancer medicines for children, 2011–2021. eClinicalMedicine 59, pages 101966.
Crossref
Alessandra Cianflone, Fabio Savoia, Rosanna Parasole & Peppino Mirabelli. (2023) Pediatric biobanks to enhance clinical and translational research for children. European Journal of Pediatrics 182:4, pages 1459-1468.
Crossref
Danila Azzolina, Rosanna Comoretto, Liviana Da Dalt, Silvia Bressan & Dario Gregori. (2023) A SuperLearner-enforced approach for the estimation of treatment effect in pediatric trials. DIGITAL HEALTH 9.
Crossref
Fahad Siddiqui, Muhammad Harris Shoaib, Farrukh Rafiq Ahmed, Faaiza Qazi, Rabia Ismail Yousuf, Muhammad Talha Usmani, Muhammad Talha Saleem & Kamran Ahmed. (2023) Formulation development and optimization of taste-masked azithromycin oral suspension with ion exchange resins: Bioanalytical method development and validation, in vivo bioequivalence study, and in-silico PBPK modeling for the paediatric population. Journal of Drug Delivery Science and Technology 79, pages 104048.
Crossref
Mariana Q. S. Soares, Jeroen Van Dessel, Reinhilde Jacobs, Gustavo Z. Ferreira, Paulo Sérgio da Silva Santos, Laura F. P. Nicolielo, Marco A. H. Duarte & Izabel R. F. Rubira‐Bullen. (2022) High doses of zoledronic acid induce differential effects on femur and jawbone microstructure. Clinical and Experimental Dental Research 8:6, pages 1487-1495.
Crossref
Alice C. Wismer, Milenko Rakic, Claudia E. Kuehni, Manon Jaboyedoff, Fabrizio Romano, Matthias V. Kopp, Julia Brandenberger, Georg Staubli & Kristina Keitel. (2022) Consensus Minimal Dataset for Pediatric Emergency Medicine in Switzerland. Pediatric Emergency Care 38:10, pages 511-516.
Crossref
Deejesh Subramanian, Cintia V. Cruz & Facundo Garcia-Bournissen. (2022) Systematic Review of Early Phase Pediatric Clinical Pharmacology Trials. The Journal of Pediatric Pharmacology and Therapeutics 27:7, pages 609-617.
Crossref
Souhaila H. El Moukhtari, Elisa Garbayo, Ana Fernández-Teijeiro, Carlos Rodríguez-Nogales, Patrick Couvreur & María J. Blanco-Prieto. (2022) Nanomedicines and cell-based therapies for embryonal tumors of the nervous system. Journal of Controlled Release 348, pages 553-571.
Crossref
Jasmeet Sidhu, Ashish Narayan Masurekar, Manash Pratim Gogoi, Caroline Fong, Tasos Ioannou, Taha Lodhi, Catriona Parker, Jizhong Liu, Amy A. Kirkwood, Anthony V. Moorman, Kiranmoy Das, Nicholas J. Goulden, Ajay Vora, Vaskar Saha & Shekhar Krishnan. (2022) Activity and toxicity of intramuscular 1000 iu /m 2 polyethylene glycol‐ E. coli L‐asparaginase in the UKALL 2003 and UKALL 2011 clinical trials . British Journal of Haematology 198:1, pages 142-150.
Crossref
Yarmarly Guerra Valero, Tavey Dorofaeff, Lisa Parker, Mark G. Coulthard, Louise Sparkes, Jeffrey Lipman, Steven C. Wallis, Jason A. Roberts & Suzanne L. Parker. (2021) Microsampling to support pharmacokinetic clinical studies in pediatrics. Pediatric Research 91:6, pages 1557-1561.
Crossref
Jianwen Xu, Rongfang Lin, Yong Chen, Xiang You, Pinfang Huang & Cuihong Lin. (2021) Physiologically Based Pharmacokinetic Modeling and Dose Adjustment of Teicoplanin in Pediatric Patients With Renal Impairment. The Journal of Clinical Pharmacology 62:5, pages 620-630.
Crossref
Dawood Alyami, Ajaim A Alyami, Abdulaziz Alhossan & Mohammed Salah. (2022) Awareness and Views of Pharmacists and Physicians Toward Prescribing of Drugs for Off-Label Use in the Pediatric Population in Saudi Arabia. Cureus.
Crossref
Vinicius M. Alves, Daniel Korn, Vera Pervitsky, Andrew Thieme, Stephen J. Capuzzi, Nancy Baker, Rada Chirkova, Sean Ekins, Eugene N. Muratov, Anthony Hickey & Alexander Tropsha. (2022) Knowledge-based approaches to drug discovery for rare diseases. Drug Discovery Today 27:2, pages 490-502.
Crossref
Chris A. Rees, Michael C. Monuteaux, Vendela Herdell, Eric W. Fleegler & Florence T. Bourgeois. (2021) Correlation Between National Institutes of Health Funding for Pediatric Research and Pediatric Disease Burden in the US. JAMA Pediatrics 175:12, pages 1236.
Crossref
Caterina Strisciuglio, Vincenzo Coppola, Marina Russo, Carlo Tolone, Gian Luigi Marseglia, Alberto Verrotti, Silvia Caimmi, Claudia Caloisi, Valeria D'Argenio, Lucia Sacchetti & Annamaria Staiano. (2021) Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical Trial. Frontiers in Pediatrics 9.
Crossref
Milenko Rakic, Manon Jaboyedoff, Sara Bachmann, Christoph Berger, Manuel Diezi, Philipp do Canto, Christopher B. Forrest, Urs Frey, Oliver Fuchs, Alain Gervaix, Amalia Stefani Gluecksberg, Michael Grotzer, Ulrich Heininger, Christian R. Kahlert, Daniela Kaiser, Matthias V. Kopp, Roger Lauener, Thomas J. Neuhaus, Paolo Paioni, Klara Posfay-Barbe, Gian Paolo Ramelli, Umberto Simeoni, Giacomo Simonetti, Christiane Sokollik, Ben D. Spycher & Claudia E. Kuehni. (2021) Clinical data for paediatric research: the Swiss approach. BMC Proceedings 15:S13.
Crossref
Yarmarly C. Guerra Valero, Tavey Dorofaeff, Jason A. Roberts, Jeffrey Lipman, Mark G. Coulthard, Louise Sparkes, Steven C. Wallis & Suzanne L. Parker. (2021) Development and validation of a UHPLC-MS/MS method to measure cefotaxime and metabolite desacetylcefotaxime in blood plasma: a pilot study suitable for capillary microsampling in critically ill children. Analytical and Bioanalytical Chemistry 413:17, pages 4483-4491.
Crossref
Emma Kim, Geoffrey Lee & Gayle Fischer. (2020) Use of narrowband ultraviolet B (NBUVB) in paediatric psoriasis: A systematic literature review and meta‐analysis. Australasian Journal of Dermatology 62:2, pages 124-129.
Crossref
Abdallah Derbalah, Stephen Duffull, Katie Moynihan & Hesham Al-Sallami. (2020) The Influence of Haemostatic System Maturation on the Dose–Response Relationship of Unfractionated Heparin. Clinical Pharmacokinetics 60:4, pages 491-499.
Crossref
Brinal Figer, NithyaJaideep Gogtay & UrmilaMukund Thatte. (2021) Compliance of Mumbai-based clinical trial sites with the Quality Council of India guidelines and evaluation of the challenges faced by the investigators. Perspectives in Clinical Research 12:3, pages 133.
Crossref
Madalina Petran, Dorin Dragos & Marilena Gilca. (2020) Historical ethnobotanical review of medicinal plants used to treat children diseases in Romania (1860s–1970s). Journal of Ethnobiology and Ethnomedicine 16:1.
Crossref
Oihane E. Albóniga, Oskar González, Rosa M. Alonso, Yun Xu & Royston Goodacre. (2020) Comparison of liver and plasma metabolic profiles in piglets of different ages as animal models for paediatric population. The Analyst 145:21, pages 6859-6867.
Crossref
Vahid Eslami, Morgan C. Lola, Steven C. Karceski, Jose E. Cavazos & Charles Ákos Szabó. (2020) Changing characteristics of epilepsy interventional clinical trials over the last decade: Clinicaltrials.Gov registry. Epilepsy Research 164, pages 106350.
Crossref
David E. Procaccini, Katie Lobner, Blair Anton & Sapna R. Kudchadkar. (2020) Melatonin Use in Hospitalized Children for Non‐Anesthetic Indications: A Systematic Review. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy 40:7, pages 692-703.
Crossref
Lucia Ruggieri, Donato Bonifazi, Annalisa Landi, Fedele Bonifazi, Franco Bartoloni, Mary Costello, Maria Grazia Felisi, Elke Gasthuys, Anila Godo, Federico Martinon Torres, David Nadal, Lieve Nuytinck, Francesca Rocchi, Mark Turner & Adriana Ceci. (2019) Survey by TEDDY European Network of Excellence for Paediatric Clinical Research demonstrates potential for Europe‐wide trials. Acta Paediatrica 109:3, pages 607-612.
Crossref
Alexis E. Horace, Negar Golchin, Elia M. Pestana Knight, Neal V. Dawson, Xuan Ma, James A. Feinstein, Hannah K. Johnson, Lawrence Kleinman & Paul M. Bakaki. (2019) A Scoping Review of Medications Studied in Pediatric Polypharmacy Research. Pediatric Drugs 22:1, pages 85-94.
Crossref
Federica Arienti, Claudia Pansieri, Chiara Pandolfini, Andrea Biondi & Maurizio Bonati. (2019) Globalization of pediatric research: pharmacological RCTs in Latin America. Italian Journal of Pediatrics 45:1.
Crossref
Antonio Y Hardan, Robert L Hendren, Michael G Aman, Adelaide Robb, Raun D Melmed, Kristen A Andersen, Rachel Luchini, Rezwanur Rahman, Sanjida Ali, X Daniel Jia, Madhuja Mallick, Jordan E Lateiner, Robert H Palmer & Stephen M Graham. (2019) Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies. Autism 23:8, pages 2096-2111.
Crossref
Nicole A. Wilson. (2019) CORR Insights®: Biomechanical Function and Size of the Anteromedial and Posterolateral Bundles of the ACL Change Differently with Skeletal Growth in the Pig Model. Clinical Orthopaedics & Related Research 477:9, pages 2175-2177.
Crossref
Laura Karas, Christine Y. Lu, Pankaj B. Agrawal & Maryam M. Asgari. (2019) The impact of the Orphan Drug Act on Food and Drug Administration-approved therapies for rare skin diseases and skin-related cancers. Journal of the American Academy of Dermatology 81:3, pages 867-877.
Crossref
Elizabeth J. Thompson, Huali Wu, Anil Maharaj, Andrea N. Edginton, Stephen J. Balevic, Marjan Cobbaert, Anthony P. Cunningham, Christoph P. Hornik & Michael Cohen-Wolkowiez. (2019) Physiologically Based Pharmacokinetic Modeling for Trimethoprim and Sulfamethoxazole in Children. Clinical Pharmacokinetics 58:7, pages 887-898.
Crossref
Jay J. H. Park, Ellie Siden, Ofir Harari, Louis Dron, Reham Mazoub, Virginia Jeziorska, Noor-E Zannat, Heather Gadalla, Kristian Thorlund & Edward J. Mills. (2020) Interventions to improve linear growth during exclusive breastfeeding life-stage for children aged 0-6 months living in low- and middle-income countries: a systematic review with network and pairwise meta-analyses. Gates Open Research 3, pages 1720.
Crossref
Jay J. H. Park, Ellie Siden, Ofir Harari, Louis Dron, Reham Mazoub, Virginia Jeziorska, Noor-E Zannat, Heather Gadalla, Kristian Thorlund & Edward J. Mills. (2019) Interventions to improve linear growth during exclusive breastfeeding life-stage for children aged 0-6 months living in low- and middle-income countries: a systematic review and network and pairwise meta-analyses. Gates Open Research 3, pages 1720.
Crossref
Nuno Torres, Daniel Martins, António J. Santos, Diana Prata & Manuela Veríssimo. (2018) How do hypothalamic nonapeptides shape youth’s sociality? A systematic review on oxytocin, vasopressin and human socio-emotional development. Neuroscience & Biobehavioral Reviews 90, pages 309-331.
Crossref
Sydney T. Grob & Jean M. Mulcahy Levy. (2017) Improving Diagnostic and Therapeutic Outcomes in Pediatric Brain Tumors. Molecular Diagnosis & Therapy 22:1, pages 25-39.
Crossref
Rita HumeniukDionna Green. (2015) Medical Countermeasures Development for Neonates. NeoReviews 16:12, pages e701-e707.
Crossref
Sam Salman, Daryl Bendel, Toong C. Lee, David Templeton & Timothy M. E. Davis. (2015) Pharmacokinetics of a Novel Sublingual Spray Formulation of the Antimalarial Drug Artemether in African Children with Malaria. Antimicrobial Agents and Chemotherapy 59:6, pages 3208-3215.
Crossref
D?rte Wolf & Joachim Otto. (2015) Efficacy and Safety of a Lidocaine Gel in Patients from 6 Months up to 8 Years with Acute Painful Sites in the Oral Cavity: A Randomized, Placebo-Controlled, Double-Blind, Comparative Study. International Journal of Pediatrics 2015, pages 1-6.
Crossref
Kevin E. Chapman, Yogendra H. Raol & Amy Brooks-Kayal. (2012) Neonatal seizures: controversies and challenges in translating new therapies from the lab to the isolette. European Journal of Neuroscience 35:12, pages 1857-1865.
Crossref
Frank M Balis & Elizabeth Fox. (2012) Challenges of developing new drugs for childhood cancers. Clinical Investigation 2:3, pages 291-300.
Crossref
Karel Allegaert. (2012) Clinical pharmacological studies in children: From exploratory towards confirmation driven methodology. World Journal of Clinical Pediatrics 1:2, pages 3.
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:

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:

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.