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Author Details

Robert M Nelson
The Ottawa Hospital, University of Ottawa
1990
107
24
PMIDPaper TitleJournal TitlePublished Year
36341541Strategies to facilitate adolescent access to medicines: Improving regulatory guidance.Clin Trials2023
36843283Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects.J Biopharm Stat2023
35006587Extrapolation as a Default Strategy in Pediatric Drug Development.Ther Innov Regul Sci2022
36045315The Role of Master Protocols in Pediatric Drug Development.Ther Innov Regul Sci2022
33811302Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children's Pediatric Innovation Research Forum.Ther Innov Regul Sci2021
32208075The Use of Pediatric Extrapolation to Avoid Unnecessary Pediatric Clinical Trials.Am J Bioeth2020
33168084Spinal muscular atrophy type III complicated by spinal superficial siderosis: a case report with molecular and neuropathological findings.Acta Neuropathol Commun2020
30787097The Potential Benefits of Research May Justify Certain Research Risks.Pediatrics2019
30736861Regulatory strategies for rare diseases under current global regulatory statutes: a discussion with stakeholders.Orphanet J Rare Dis2019
31084211Incorporating Innovative Techniques Toward Extrapolation and Efficient Pediatric Drug Development.Ther Innov Regul Sci2019
29466124A Framework for Evaluating a Minor's Involvement in Medical Decision Making.Am J Bioeth2018
29910527The Food and Drug Administration's Federal Review of a Pediatric Muscular Dystrophy Protocol.IRB2018
30204722Advancing HIV Biomedical Prevention Research for At-Risk Adolescents.J Acquir Immune Defic Syndr2018
27760875Spinal Muscular Atrophy Type I: Is It Ethical to Standardize Supportive Care Intervention in Clinical Trials?J Child Neurol2017
28987269Enrollment of Neonates in More Than One Clinical Trial.Clin Ther2017
28510297Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary.Clin Pharmacol Ther2017
28777661Minimal Risk in Pediatric Research: A Philosophical Review and Reconsideration.Account Res2017
28507222Meeting the goal of concurrent adolescent and adult licensure of HIV prevention and treatment strategies.J Med Ethics2017
286694472017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil.J Am Coll Cardiol2017
286634372017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil.Circ Cardiovasc Qual Outcomes2017
27040726Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.J Clin Pharmacol2016
27416322Reliable and developmentally appropriate study end points are needed to achieve drug development for treatment of pediatric pulmonary arterial hypertension.J Perinatol2016
25600385SUPPORT: Risks, Harms, and Equipoise.Hastings Cent Rep2015
30227031Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014.Ther Innov Regul Sci2015
26323417Ethical Considerations in Conducting Pediatric and Neonatal Research in Clinical Pharmacology.Curr Pharm Des2015
26095312Microdosing Studies in Children: A US Regulatory Perspective.Clin Pharmacol Ther2015
25856596Right job, wrong tool: a commentary on designing clinical trials for Ebola virus disease.Am J Bioeth2015
25944196The author replies.Hastings Cent Rep2015
25748271Tablet Computing in Clinical Training of Pediatric Residents.Telemed J E Health2015
24121142Alternate endpoints and clinical outcome assessments in pediatric ulcerative colitis registration trials.J Pediatr Gastroenterol Nutr2014
24866782Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 2: data extrapolation, trial design, and pharmacokinetics.J Pediatr Gastroenterol Nutr2014
24058304Parental permission and child assent in research on children.Yale J Biol Med2013
22367000Is there an objective way to compare research risks?J Med Ethics2012
22508918Factors related to voluntary parental decision-making in pediatric oncology.Pediatrics2012
22562947A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settings.J Med Ethics2012
21176882Research challenges in central nervous system manifestations of inborn errors of metabolism.Mol Genet Metab2011
21806428The concept of voluntary consent.Am J Bioeth2011
21806424Response to open peer commentaries on "the concept of voluntary consent".Am J Bioeth2011
21882114Ethical considerations in conducting pediatric research.Handb Exp Pharmacol2011
21693541Relationship of external influence to parental distress in decision making regarding children with a life-threatening illness.J Pediatr Psychol2011
21678206A relative standard for minimal risk is unnecessary and potentially harmful to children: lessons from the Phambili trial.Am J Bioeth2011
21402793The decision making control instrument to assess voluntary consent.Med Decis Making2011
20235861The challenges of collaboration for academic and community partners in a research partnership: points to consider.J Empir Res Hum Res Ethics2010
20945260An open letter to institutional review boards considering Northfield Laboratories' PolyHeme® trial.Am J Bioeth2010
20571419Ethical and regulatory considerations for the inclusion of adolescents in HIV biomedical prevention research.J Acquir Immune Defic Syndr2010
20133406Assessment of parental decision-making in neonatal cardiac research: a pilot study.J Med Ethics2010
20235862Nine key functions for a human subjects protection program for community-engaged research: points to consider.J Empir Res Hum Res Ethics2010
20235860Human subjects protections in community-engaged research: a research ethics framework.J Empir Res Hum Res Ethics2010
19194453Parental perception of time and decision-making in neonatal research.J Perinatol2009
19754231Challenges in measuring a new construct: perception of voluntariness for research and treatment decision making.J Empir Res Hum Res Ethics2009
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Collaborators

University of Rochester School of Medicine and Dentistry.
Co-authored papers 8
Children's Hospital of Philadelphia
Co-authored papers 7
Cincinnati Children's Hospital Medical Center, University of Cincinnati
Co-authored papers 5
The Kennedy Institute of Ethics, Georgetown University
Co-authored papers 4
Children's Hospital of Philadelphia
Co-authored papers 4
Children's National Hospital
Co-authored papers 4
Children's Hospital of Philadelphia
Co-authored papers 3
University of Utah
Co-authored papers 3
Co-authored papers 3
Center for Drug Evaluation and Research
Co-authored papers 3
Children's National Hospital
Co-authored papers 2
Children's Medical Center of Dallas
Co-authored papers 2
Emory University
Co-authored papers 2
University of Maryland School of Medicine
Co-authored papers 2
Boston Children's Hospital
Co-authored papers 2
Children's National Hospital, George Washington University School of Medicine
Co-authored papers 2
Children's Hospital of Philadelphia
Co-authored papers 2
University of Michigan Congenital Heart Center ann arbor
Co-authored papers 2
Heart Institute, Children's Hospital Colorado, University of Colorado
Co-authored papers 2
Co-authored papers 2
Duke University Medical Center
Co-authored papers 1
University of Toronto
Co-authored papers 1
Boston Children's Hospital, Harvard Medical School
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Center for Drug Evaluation and Research
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NIH Clinical Center
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Children's Hospital of Philadelphia
Co-authored papers 1
Hospital for Sick Children, University of Toronto
Co-authored papers 1
National Center for Advancing Translational Sciences, National Institutes of Health
Co-authored papers 1