Science & Research

Publications

PUBLICATIONS: 2003 - 2016

From the Office of Pediatric Therapeutics and FDA

A. PEER REVIEWED ARTICLES PUBLISHED:

Published (N=81) ; Accepted (N=3)

2016 (N=4)
  1. Medical Devices and Adolescents: Points to Consider. disclaimer iconJoy H. Samuels-Reid MD, Judith U. Cope, MD, MPH
    JAMA Pediatrics , September 12, 2016. doi:10.1001/jamapediatrics.2016.1351
    [Epub ahead of print]
  2. Reliable and Developmentally-appropriate Study Endpoints Are Needed to Facilitate Drug Development for Treatment of Pediatric Pulmonary Arterial Hypertension. Haihao Sun, MD, PhD, Norman Stockbridge, MD, Ronald L. Ariagno, MD Dianne Murphy, MD, Robert M. Nelson, MD, PhD, William Rodriguez, MD, PhD
    J. Perinatol. 2016 July 14. Doi: 10. 1038/jp.2016.103 [Epub ahead of print]
  3. A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013.disclaimer icon Egger GF, Wharton GT, Malli S, Temeck J, Murphy MD, Tomasi P
    Therapeutic Innovation & Regulatory Science, 1-9. May 2016
    DOI: 10.1177/2168479016646809
  4. Pharmacology Review: The Role of Biomarkers and Surrogate End Points in Drug Development for Neonatal Pulmonary Arterial Hypertension disclaimer icon
    Haihao Sun, MD, PhD; Norman Stockbridge, MD; Ronald L. Ariagno, MD; Dianne Murphy, MD
    NeoReviews. Feb 2016, 17 (2) e87-e92; DOI: 10.1542/neo.17-2-e87
Accepted (N=3)
  1. Spinal Muscular Atrophy Type I: Is It Ethical to Standardize Supportive Care Intervention in Clinical Trials?Richard S. Finkel, MD, Kathie M. Bishop, PhD, Robert M. Nelson, MD, PhD
    (Accepted in Journal of Child Neurology on July 26, 2016)
  2. Pediatric Crohn’s Disease Clinical Outcome Assessments and Biomarkers: Current State and Path Forward for Global Collaboration. Haihao Sun, MD, PhD; Richard Vesely, MD; Kerry Jo Lee, MD; Agnes Kline, MD; Mutsuhiro Ikima, MD; Andrew E. Mulberg, MD on behalf of the International Inflammatory Bowel Disease (i-IBD) Working Group.
    (Accepted in Journal of Pediatric Gastroenterology & Nutrition on May 18, 2016)
  3. Stratification, Hypothesis Testing, and Clinical Trial Simulation in Pediatric Drug Development. Ann W. McMahon, MD, MS, Kevin Watt, MD, MPH, Jian Wang, PhD, Dionna Green, MD, Ram Tiwari, PhD, and Gilbert Burckart, PharmD
    (Accepted in Therapeutic Innovation & Regulatory Science on May 3, 2016)
2015 (N=14)
  1. Pediatric Registries at the Food and Drug Administration: Design Aspects that Increase their Likelihood of Success. disclaimer icon Scott K. Winiecki, MD, M. Isabel Tejero-Taldo, MD, PhD, Debbie Avant, RPh, Dianne Murphy MD, Ann W. McMahon, MD, MS
    Pharmacoepidemiology and Drug Safety. 12/2015; DOI: 10.1002/pds.3939
  2. FDA’s Pediatric Advisory Committee Post-market Safety Monitoring of Drugs, Biologics and Vaccines, 2007-2013. Judith U. Cope, MD, MPH, Geoffrey L. Rosenthal, MD, PhD, Pamela Weinel, MS, MBA, RN, Amy Odegaard, MPH, Dianne M. Murphy, MD, FAAP
    Pediatrics. 2015 Nov 23 [Epub ahead of print]
  3. Applying 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. disclaimer icon Martin Offringa, Jonathan M. Davis, Mark A. Turner, Robert Ward, Sam Maldonado, Anne Zajicek, Daniel Benjamin Jr, Christina Bucci-Rechtweg, Robert M Nelson
    Therapeutic Innovation & Regulatory Science September 2015 49: 623-631
  4. Microdosing Studies in Children: A U.S. Regulatory Perspective.  Roth-Cline M
    Clin Pharmacol Ther. 2015 Sep;98 (3):232-3
  5. Infant formula and neurocognitive outcomes: impact of study end-point selection disclaimer icon. H Sun, P G Como, L C Downey D Murphy, R L Ariagno and W Rodriguez.
    Journal of Perinatology .2015 August 6. doi: 10.1038/jp.2015.87 [Epub ahead of print]
  6. Safety of octreotide in hospitalized infants.
    Testoni D, Hornik CP, Neely ML, Yang Q, McMahon AW, Clark RH, Smith PB; Best Pharmaceuticals for Children Act - Pediatric Trials Network Administrative Core Committee.
    Early Hum Dev. 2015 Jul; 91(7):387-92
  7. Pediatric Post-Marketing Safety Systems in North America: Assessment of the Current Status.
    Ann W. McMahon, MD, MS; Gerold T. Wharton, MS; Renan Bonnel, PharmD, MPH; Mary DeCelle, BS; Kimberley Swank, Pharm.D.; Daniela Testoni, MD, MHS; Judith U. Cope, MD, MPH; P. Brian Smith, MD, MPH, MHS; Eileen Wu, Pharm.D.; Reese H. Clark, MD; M. Dianne Murphy, MD
    Pharmacoepidemiology Drug Saf, 2015 Jun 22. doi: 10.1002/pds.3813 [Epub ahead of print]
  8. Well-defined and Reliable Clinical Outcome Assessments for Pediatric Crohn’s Disease: A Critical Need for Drug Development
    Haihao Sun, MD, PhD Elektra J. Papadopoulos, MD, MPH, Jeffrey S. Hyams, MD, Donna Griebel, MD; Jessica J. Lee, MD; Juli Tomaino, MD; and Andrew E. Mulberg, MD
    J Pediatr Gastroenterol Nutr. 2015 Jun;60(6):729-36
  9. A survey of neonatal pharmacokinetic and pharmacodynamic studies in pediatric drug development.
    Jian Wang, PhD, Debbie Avant, RPh, Dioanna Green, MD, Shirley Seo, PhD, Jeffrey Fisher, PhD, Andrew E. Mulberg, MD, Susan K. McCune, MD, Gilbert J. Burckart, PharmD
    Clin Pharmacol Ther. 2015 May 14. doi: 10.1002/cpt.149. [Epub ahead of print]
  10. Predicting Neonatal Pharmacokinetics from Prior Data Using Population Pharmacokinetic Modeling. disclaimer icon
    Jian Wang, PhD, Andrea N. Edginton, PhD, Debbie Avant, RPh, Gilbert J. Burckart, PharmD
    J Clin Pharmacol, April 19, 2015. DOI 10.1002/jcph.524
  11. Right job, wrong tool: a commentary on designing clinical trials for Ebola virus disease. disclaimer iconNelson RM, Roth-Cline M, Prohaska K, Cox E, Borio L, Temple R
    Am J Bioeth. 2015; 15 (4): 33-6
  12. Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports. disclaimer icon
    Judith U. Cope, MD, MPH, Gregory H. Reaman, MD, Joseph M. Tonning, MD, MPH
    Sarcoma, Vol. 2015, Article ID 948159, 11 pages, 2015. doi:10.1155/2015/948159.
  13. “SUPPORT: Risks, Harms, and Equipoise.”
    Robert M. Nelson
    Hastings Center Report 45, no. 1 (Jan- Feb 2015): 40-42. DOI:10.1002/hast.41
  14. Ethical considerations in conducting pediatric and neonatal research in clinical pharmacology. Roth-Cline M, Nelson RM.
    Curr Pharm Des. 2015; 21(39): 5619-35
  2014 (N=10)
  1. The Ethical Principle of Scientific Necessity in Pediatric Research. disclaimer icon
    Roth-Cline M, Nelson RM.
    American Journal of Bioethics December 2014; 14 (12):1
  2. FDA Implementation of the Expanded Access Program in the United Statesdisclaimer icon
    Roth-Cline M, Nelson RM.
    American Journal of Bioethics October 17, 2014: 11:14
  3. Blood Glucose Assessment in Youth before Starting a Second Generation Antipsychotic is Recommended but Rarely Performed. disclaimer icon
    Marsha A. Raebel, PharmD, Robert Penfold, PhD, Ann W. McMahon, MD, MS ,Marsha Reichman, PhD , Susan Shetterly, MS, Glenn Goodrich, MS, Susan Andrade, ScD, Christoph U. Correll, MD, and Tobias Gerhard, PhD
    Pediatrics (Published online October 6, 2014)
  4. Joining Forces: A Call for Greater Collaboration To Study New Medicines in Children and Adolescents with Type 2 Diabetes.
    Janina Karres PhD, Valerie Pratt MD, Jean-Marc Guettier MD, Jean Temeck MD, William V. Tamborlane MD, David Dunger MD PhD, Cristina Bejnariu MD1, Carine DeBeaufort MD PhD, Paolo Tomasi MD PhD
    Diabetes Care October 2014; 37: 2665
  5. Systemic Review of Drug Labeling Changes That Inform Pediatric Weight Gain.disclaimer icon
    Ingrid Kohlstadt, MD, MPH, M. Dianne Murphy, MD
    J J Neur Neurosci September 2014; 1(2);013
  6. Impact of Pediatric Exclusivity on Drug Labeling and Demonstrations of Efficacy .disclaimer icon
    Gerold T. Wharton, BA; Dianne Murphy, MD, Debbie Avant, RPh, John Goldsmith, PhD, Grace Chai, PharmD, William J. Rodriguez, MD, PhD, Eric L. Eisenstein, DBA
    Pediatrics (Published online July 14, 2014)
  7. Steps towards Harmonization for Clinical Development of Medicines in Pediatric Ulcerative Colitis – a Global Scientific Discussion.disclaimer icon
    Part 2: Data Extrapolation, Trial Design, and Pharmacokinetics
    Haihao Sun, MD, PhD, Richard Vesely, MD, Robert M Nelson, MD, PhD, Jan Taminiau, MD, Peter Szitanyi, MD, Maria Isaac, MD, Agnes Klein, MD, Shinobu Uzu, Donna Griebel, MD, and Andrew E. Mulberg, MD on behalf of the international Inflammatory Bowel disease (i-IBD) Working Group
    Journal of Pediatric Gastroenterology & Nutrition 2014 June 23 [Epub ahead of print]
  8. Steps towards Harmonization for Clinical Development of Medicines in Pediatric Ulcerative Colitis—a Global Scientific Discussion.disclaimer icon
    Part 1: Efficacy Endpoints and Disease Outcome Assessments
    Haihao Sun, MD, PhD, Richard Vesely, MD, Jan Taminiau,MD, Peter Szitanyi, MD,Maria Isaac, MD, Agnes Klein, MD, Shinobu Uzu, Donna Griebel, MD, Andrew E. Mulberg, MD on behalf of the International Inflammatory Bowel Disease (i-IBD) Working Group
    Journal of Pediatric Gastroenterology & Nutrition 2014 Jun 9 [Epub ahead of print]
  9. Pediatric Oncology Drug Shortages: A Multifaceted Problem.disclaimer icon
    Dianne Murphy, Gregory Reaman and Capt Valerie Jensen
    Pediatrics (Published online February 2, 2014)
  10. Alternate endpoints and clinical outcome assessments in pediatric ulcerative colitis registration trials.
    Sun H, Lee JJ, Papadopoulos EJ, Lee CS, Nelson RM, Sachs HC, Rodriguez WJ, Mulberg AE.
    J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):12-7
2013 (N=6)
  1. Drug Labeling and Exposure in Neonates.disclaimer icon
    Matthew M. Laughon, MD, Debbie Avant, RPh, Nidhi Tripathi, MD, Christoph Hornik, MD, Michael Cohen-Wolkowiez, MD, Reese Clark, MD, P. Brian Smith, MD, William Rodriguez, MD, PhD
    JAMA Pediatr (Published online December 9, 2013)
  2. Systematic Review of Alternate Endpoints and Clinical Outcome Assessments in Pediatric Ulcerative Colitis Registration Trials.
    Sun H, Lee JJ, Papadopoulos EJ, Lee CS, Nelson RM, Sachs HC, Rodriguez WJ, Mulberg AE.
    J Pediatr Gastroenterol Nutr 2013 Oct 10 [Epub ahead of print]
  3. Parental permission and child assent in research on children.
    Roth-Cline M, Nelson RM.
    Yale J Biol Med. 2013 Sep 20;86(3):291-301.
  4. Clinician uptake of obesity-related drug information: a qualitative assessment using continuing medical education activities.disclaimer icon
    Ingrid Kohlstadt and Gerold Wharton.
    Journal of Nutrition 2013, 12:44
  5. *Failed Pediatric Trials of Acute Migraine Treatments: Lessons Learned From a Systematic Review of Trial Data Submitted to the Foodand Drug Administration (FDA).disclaimer icon;
    Haihao Sun, MD, PhD, Eric Bastings, MD, Jean Temeck, MD, P. Brian Smith, MD MPH MHS, Angela Men, MD, Veneeta Tandon, PhD, Dianne Murphy, MD; William Rodriguez, MD, PhD
    JAMA Pediatrics March 2013; 167 (3): 243-249
  6. The Impact of the Pediatric Written Request Process on Drug Development in Childhood Cancer.disclaimer icon
    Kristen M.Snyder, MD, Gregory Reaman, MD, Debbie Avant, RPh, Richard Pazdur, MD
    Pediatric Blood & Cancer (Published online Jan 13, 2013)
2012 (N=10)
  1. The Globalization of Pediatric Clinical Trials.disclaimer icon
    Julia Dunne, MD, Dianne Murphy, MD, William Rodriguez, MD, PhD
    Pediatrics December 2012;130 (6): e1583 -e1591 (Published online November 5,2012)
  2. Pediatric Use of Insulin Pump Technology: A Retrospective Study of Adverse events in Children ages 1-12 Years.disclaimer icon
    Judith U. Cope, MD, MPH, Joy H. Samuels-Reid, MD, Audrey E. Morrison, RN, BSN.
    J Diabetes Sci Technol September 2012; 6(5):1053-1059**
  3. Trends of Outpatient Prescription Drug Utilization in U.S. Children, 2002 - 2010.disclaimer icon
    Grace Chai, Pharm D, Laura Governale, Pharm D, MBA, Ann W. McMahon, MD, MS, Judy Staffa, PhD, R Ph, Dianne Murphy, MD
    Pediatrics, 2012 June 18 [Epub ahead of print]
  4. Pediatric Devices and Adverse Events from A to Z: Understanding the Benefits and Risks.disclaimer icon
    Joy Samuels-Reid, MD, Brenda Lawrence, MD, Courtney Millin, PhD, Judith Cope, MD, MPH
    Expert Review of Medical Devices, June 2012; 9 (3): 275-282 **
  5. A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settings.disclaimer icon
    Bright Pl, Nelson RM
    J Med Ethics. 2012 May 5.[Epub ahead of print] **
  6. Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials.disclaimer icon
    Leong, R., Vieira, ML, Zhao, P., Mulugeta, Y., Lee, CS., Huang, SM., Burckart, GJ.
    Clinical Pharmacology & Therapeutics. 2012 May;91(5):926-31.
  7. Research Letter: Pediatric Information in Drug Product Labeling.disclaimer icon
    Aaron N. Sachs, BS, Debbie Avant, RPh, Catherine S. Lee, DrPH, William Rodriguez, MD, PhD, M. Dianne Murphy, MD
    JAMA May 2012; 307(18): 1914-1915
  8. Factors Related to Voluntary Parental Decision-Making in Pediatric Oncology.disclaimer icon
    Victoria A. Miller, PhD, Robert M. Nelson, MD, PhD
    Pediatrics April 2012; 129: 903-909
  9. Is there an objective way to compare research risks?disclaimer icon
    Rossi J, Nelson RM
    J Med Ethics. 2012 Feb 25. [Epub ahead of print] **
  10. What Orphan Drug Act has done lately for children with rare diseases: A 10-Year Analysis.disclaimer icon
    Chandana Thorat, BTech, Kui Xu, MD, PhD, Scott Freeman, PhD, Renan Bonnel, PharmD, MPH, Francesca Joseph, MD, M Phillips, PhD, DSc, Menfo Imoisili, MD, MPH
    Pediatrics Feb 2012/peds.2011-1798
2011 (N=2)
  1. An Analysis of the Effect of Age on Risks of Long-Acting Beta-2 Agonists.;disclaimer icon
    Ann W. McMahon, MD, MS, Mark S. Levenson, PhD, Bradley W. McEvoy, DrPH, Andrew D. Mosholder, MD, MPH, and Dianne Murphy, MD
    Pediatrics October 2011/peds.2010-1720
  2. Extrapolating of Adult and Other Data in Pediatric Drug Development Programs.disclaimer icon
    Julia Dunne, William Rodriguez, Dianne Murphy, Nhi Beasley, Gilbert Burckhart, Jane Filie, Linda Lewis, Hari Sachs, Philip Sheridan, Peter Starke and Lynne Yao
    Pediatrics October 2011; peds.2010-3487
2010 (N= 8)
  1. Globalization Facilitates Pediatric Drug Development in the 21st Century.
    Julia Dunne, Lala Margaryants, M. Dianne Murphy, Ann M. Myers, Debbie Avant and William J. Rodriguez
    Drug Information Journal 2010 : 44(06)
  2. Emergency Department (ED) Visits for Medical Device-Associated Adverse Events Among Children in United States.
    Wang C, Hefflin B, Cope JU, Gross T, Ritchie MB, Qi Y, Chu J.
    Pediatrics Aug 2010; 126: 247-259
  3. Ethical and Regulatory Considerations for the Inclusion of Adolescents in HIV Biomedical Prevention Research.disclaimer icon
    Nelson, Robert M MD, PhD; Lewis, Linda L MD; Struble, Kimberly PharmD; Wood, Susan F PhD
    J Acquir Immune Defic Syndr July 2010;54:S18–S24 **
  4. Nine key functions for a human subjects protection program for community-engaged research: points to consider.
    Ross LF, Loup A, Nelson RM, Botkin JR, Kost R, Smith GR, Gehlert S.
    J Empir Res Hum Res Ethics. Mar 2010;5(1):33-47 **
  5. The challenges of collaboration for academic and community partners in a research partnership: points to consider.
    Ross LF, Loup A, Nelson RM, Botkin JR, Kost R, Smith GR, Gehlert, S.
    J Empir Res Hum Res Ethics. Mar 2010;5(1):19-31 **
  6. Human subjects protections in community-engaged research: a research ethics framework.
    Ross LF, Loup A, Nelson RM, Botkin JR, Kost R, Smith GR, Gehlert S.
    J Empir Res Hum Res Ethics. Mar 2010;5(1):5-17 **
  7. *Cough in Pediatric Patients Receiving Angiotensin-Converting Enzyme Inhibitor Therapy or Angiotensin Receptor Blocker Therapy in Randomized Controlled Trials.
    Baker-Smith CM, Benjamin DK Jr, Califf RM, Murphy MD, Li JS, Smith PB.
    Clin Pharmacol Ther. 2010 Feb 3
  8. Assessment of parental decision-making in neonatal cardiac research: a pilot study.
    Nathan AT, Hoehn KS, Ittenbach RF, Gaynor JW, Nicolson S, Wernovsky G, Nelson RM.
    J Med Ethics. Feb 2010;36(2):106-110 **
2009 (N=6)
  1. Safety and Transparency of Pediatric Drug Trials.
    Daniel K. Benjamin Jr, MD, PhD, MPH; P. Brian Smith, MD, MHS; M. Jessica M. Sun, MD; M. Dianne Murphy, MD; Debbie Avant, RPh; Lisa Mathis, MD; William Rodriguez, MD; Robert M. Califf, MD; Jennifer S. Li, MD, MHS
    Arch Pediatr Adolesc Med. December 2009;163(12):1080-1086 **
  2. ACR Appropriateness Criteria on Developmental Dysplasia of the Hip—Child Expert Panel on Pediatric Imaging.
    Boaz K. Karmazyn, MD; Richard Gunderman, MD, PhD; Brian D. Coley, MD; Ellen R. Blatt, MD; Dorothy Bulas, MD; Lynn Fordham, MD, Daniel J. Podberesky, MD; Jeffrey Scott Prince, MD; Charles Paidas, MD; William Rodriguez, MD.
    Journal of the American College of Radiology (JACR), Volume 6 No. 8, August 2009, pgs 551-557 **
  3. Drug Therapy In Pediatrics: A Developing Field.
    Lisa Mathis, MD and William Rodriguez, MD.
    Dermatologic Therapy Journal, Volume 22, p. 257-261, May-June 2009 **
  4. Device Safety and Effectiveness in the Pediatric Population: A US FDA Perspective.
    Joy Samuels-Reid, Judith U. Cope, and Audrey E. Morrison
    Expert Rev Med. Devices 6(2), 131-135, March 2009 **
  5. Parental perception of time and decision-making in neonatal research.
    Hoehn KS, Nathan A, White LE, Ittenbach RF, Reynolds WW, Gaynor JW, Wernovsky G, Nicolson S, Nelson RM.
    J Perinatol. 2009 Jul;29(7):508-11 **
  6. Challenges in measuring a new construct: perception of voluntariness for research and treatment decision making.
    Miller VA, Reynolds WW, Ittenbach RF, Luce MF, Beauchamp TL, Nelson RM.
    J Empir Res Hum Res Ethics. 2009 Sep;4(3):21-31. **
2008 (N=14)
  1. Amoxicillin For Post-Exposure Inhalational Anthrax (Peia) In Pediatrics: Rationale For Dosing Recommendations.
    J. J. Alexander MD, MPH.; P. M. Colangelo, PharmD, PhD.; C. K. Cooper MD; R. Roberts MD; W. J. Rodriguez MD; Mary D. Murphy MD
    Pediatric Infectious Disease Journal, Volume 27, No. 11, November 2008
  2. *The economic returns of pediatric clinical trials of antihypertensive drugs.
    Carissa M. Baker-Smith, MD, MS, Daniel K. Benjamin Jr, MD, PhD, Henry G. Grabowski, PhD, Elizabeth D. Reid, BA, Barry Mangum, PharmD, John V. Goldsmith, PhD, M. Dianne Murphy, MD, Rex Edwards, BS, Eric L. Eisenstein, DBA, Jessica Sun, MD, Robert M. Califf, MD, and Jennifer S. Li, MD, MHS
    American Heart Journal Volume 156, Issue 4, October 2008, Pages 682-688
  3. Pediatric Drug Surveillance and the Food and Drug Administration's Adverse Events Reporting System: An Overview of Reports, 2003-2007.
    Rosemary Johann-Liang MD, Jo Wyeth Pharm D, Min Chen MS, MPH, and Judith Cope MD, MPH
    Pharmacoepidemiology and Drug Safety (2008), November, DOI:10.1002/pds.1679
  4. *Racial Difference in Blood Pressure Response to Angiotensin Converting Enzyme Inhibitors in Children: A Meta Analysis.
    Jennifer S. Li MD MHS, Carissa M. Baker-Smith MD, P. Brian Smith MD, Vic Hasselblad PhD, M. Dianne Murphy MD, Robert M. Califf MD, Daniel K. Benjamin Jr. MD PhD
    Clinical Pharmacology and Therapeutics, September 2008, Vol. 84, Issue 3, p.315-319
  5. *Safety Monitoring of Drugs Receiving Pediatric Marketing Exclusivity.
    Smith PB, Benjamin DK Jr, Murphy MD, Johann-Liang R, Iyasu S, Gould B, Califf RM, Li JS, Rodriguez W
    Pediatrics, Sept. 2008, Vol. 122, Issue 3. e 628-633
  6. Adolescent Use of Insulin and Patient Controlled Analgesia Pump Technology: A 10-year FDA Retrospective Study of Adverse Events.
    Judith U. Cope, MD, MPH1, Audrey E. Morrison, RN, BScN1, and Joy Samuels-Reid, MD, FAAP
    Pediatrics 2008; e1133-e1138, Sept. 2008
  7. *Racial differences in blood pressure response to angiotensin-converting enzyme inhibitors in children: a meta-analysis.
    Li JS, Baker-Smith CM, Smith PB, Hasselblad V, Murphy MD, Califf RM, Benjamin DK Jr.
    Clin Pharmacol Ther. 2008 Sep;84(3):315-9. Epub 2008 Jun 11. Review. Erratum in: Clin Pharmacol Ther. 2008 Nov;84(5):636
  8. *Pediatric Antihypertensive Trial Failures: Analysis of Endpoints and Dose Range.
    Daniel K. Benjamin, Jr., MD, PhD, MPH; P. Brian Smith, MD; Pravin Jadhav, PhD; Jogarao V. Gobburu, PhD; M. Dianne Murphy, MD; Victor Hasselblad, PhD; Carissa Baker-Smith, MD; Robert M. Califf, MD; and Jennifer S. Li, MD, MHS
    Hypertension 2008; 51; 834-840, March 10, 2008
  9. Improving Pediatric Dosing Through Pediatric Initiatives – What We Have Learned.
    William Rodriguez, M.D., Ph.D.; Arzu Selen, Ph.D.; Debbie Avant, R.Ph.; Chandra Chaurasia, Ph.D.; Terrie Crescenzi, R.Ph.; Gerlie Gieser, Ph.D.; Jennifer Di Giacinto, Pharm.D.; Shiew-Mei Huang, Ph.D.; Peter Lee, Ph.D.; Lisa Mathis, M.D.; Dianne Murphy, M.D.; Shirley Murphy, M.D.; Rosemary Roberts, M.D.; Hari Cheryl Sachs, M.D.; Sandra Suarez, Ph.D.; Veneeta Tandon, Ph.D.; and Ramana S. Uppoor, Ph.D.
    Pediatrics Vol. 121, Number 3, March 2008
  10. *Safety of Placebo Controls in Pediatric Hypertension Trials.
    Brian Smith MD MHS, Jennifer Li MD MHS, Dianne Murphy MD, Robert M. Califf and Daniel K Benjamin MD PhD MPH
    Hypertension 2008; 51; 829-833, February 19, 2008
  11. “Vertebroplasty and Kyphoplasty Are Associated with an Increased Risk of Secondary Vertebral Compression Fractures: A Population-based Cohort Study.”
    Mudano AS, Bian J, Cope JU, Curtis JR, Gross TP, Allison JJ,Kim Y, Briggs D, Melton , Juan Xi J, Saag KG.
    Osteoporosis International 2008 Sep 17
  12. Parent-child roles in decision-making about medical research. Ethics & Behaviordisclaimer icon (Special Issue: Ethical Issues in Intervention Research with Children and Adolescents).
    Miller VM, Reynolds WW and Nelson RM.
    Ethics & Behavior, 1532-7019, Volume 18, Issue 2, 2008, Pages 161 – 181
  13. The Children's Hospital of Philadelphia's experience with donation after cardiac death.
    Naim MY, Hoehn KS, Hasz RD, White LS, Helfaer MA, Nelson RM.
    Crit Care Med. 2008 Jun;36(6):1729-33
  14. Physicians' contact with families after the death of pediatric patients: a survey of pediatric critical care practitioners' beliefs and self-reported practices.
    Borasino S, Morrison W, Silberman J, Nelson RM, Feudtner C.
    Pediatrics. 2008 Dec ;122(6):e1174-8
2007 (N=1)
  1. *Economic Return of Clinical Trials Performed Under the Pediatric Exclusivity Program.
    Jennifer S. Li, MD, MHS, Eric L. Eisenstein, DBA, Henry G. Grabowski, PhD, Elizabeth D. Reid,, Barry Mangum, PharmD, Kevin A.. Schulman, MD, John V. Goldsmith, PhD, M. Dianne Murphy, MD Robert M. Califf, MD, Daniel K. Benjamin, Jr, MD, PhD
    JAMA, February 7, 2007-Vol 297, No. 5
2006 (N=3)
  1. *Peer-Reviewed Publication of Clinical Trials Completed for Pediatric Exclusivity.
    Daniel K. Benjamin, Jr, MD, PhD,Philip Brian Smith, MD,M. Dianne Murphy, MD, Rosemary Roberts, MD, Lisa Mathis, MD, Debbie Avant, RPh, Robert M. Califf, MD, Jennifer S. Li, MD, MHS.
    JAMA, September 13, 2006—Vol. 296, No. 10
  2. More Appropriate Clinical Trial Design for Drug Labels.
    McCune S, Mathis L, Cochetto D, Ball S and Rodriguez W.
    Drug Information Journal April 2006; 40:185-195
  3. *Criteria Supporting the Study of Drugs in the Newborn.
    Ward R, Benitz E, Benjamin D. Blackmon L., Giacoia G.,Huddack M., Lasky T., Rodriguez W and Selen A.
    Clinical Therapeutics September 2006; 28:1385-1398
2004 (N=1)
  1. US Food and Drug Administration approval of ciprofloxacin hydrochloride for management of postexposure inhalational anthrax.
    Meyerhoff A, Albrecht R, Meyer JM, Dionne P, Higgins K, Murphy D.
    Clin Infect Dis. 2004 Aug 1;39 (3):303-8. Epub 2004 Jul 8
2003 (N=2)
  1. Current regulatory policies regarding pediatric indications and exclusivity.
    Rodriguez WJ, Roberts R, Murphy D.
    J Pediatr Gastroenterol Nutr. 2003 Nov-Dec; 37 Suppl 1: S40-5
  2. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies.
    Roberts R, Rodriguez W, Murphy D, Crescenzi T.
    JAMA. 2003 Aug 20: 290 (7) 905-11.

B) BOOK or BOOK CHAPTERS:

Published (N=13)

  1. Pharmacovigilance in Pediatrics in Mann’s Pharmacovigilance 3rd edition.
    Dianne Murphy, Judith Cope, Solomon Iyasu. Editors: Elizabeth B. Andrews and Nicholas Moore. ISBN: 978-0-470-67104-7, Hardcover, 872 pages,
    Published by Wiley-Blackwell, June 2014
  2. Pediatric Drug Development: Concepts and Applications. 2nd Edition.
    Editors: Andrew E. Mulberg, Dianne Murphy, Julia Dunne, Lisa L. Mathis.
    Published by Wiley & Sons, August 2013
  3. Extrapolation.
    Dunne J, Rodriguez W, and Murphy D in Pediatric Drug Development: Concepts and Applications. 2nd Edition. Editors: Andrew E. Mulberg, Dianne Murphy, Julia Dunne, Lisa L. Mathis.
    Published by Wiley & Sons, August 2013
  4. Challenges Evaluating the Safety of Pediatric Therapeutic Agents in Trials and Post-Marketing Studies.
    McMahon AW, Feudtner C, Murphy D in Pediatric Drug Development: Concepts and Applications. 2nd Edition. Editors: Andrew E. Mulberg, Dianne Murphy, Julia Dunne, Lisa L. Mathis.
    Published by Wiley & Sons, August 2013
  5. Infection Control in the Child Care Center and Preschool. "Amebiasis" (p.91-94), "Cryptosporidia" (p.119-122), " Escherichia coli (Diarrhea)" (p. 138-142), and "Yersinia" (p.138-142),
    by Jantausch Barbara and Rodriguez William, edited by Dr. Leigh B. Grossman.
    ISBN: 978-1-936287-64-2, Paperback, 351 pages, Demos Medical Publishing, February 2012
  6. Ethical considerations in conducting pediatric research.
    Roth-Cline M, Gerson J, Bright P, Lee CS, Nelson RM.
    Pediatric Clinical Pharmacology. Hanb Exp Pharmacol 205: 219-44, Published by Springer, 2011
  7. United States Pediatric Legislation Impact on Pediatric Studies Pages 12-14 in Guide to Pediatric Drug Development and Clinical Research,
    Rodriguez William and Maldonado Sam Editors Klaus Rose and John N. van den Anker ISBN 978-3-8055-9362-5, Hardcover, 221 pages, June 2010, S. Karger AG, Basel
  8. Penicillins, Beta-Lactamase Inhibitors, Cephalopsporins, and Other Beta-Lactams, in Neonatal and Pediatric Pharmacology: Therapeutic Principles in Practice, Fourth Edition,
    by Sumathi Nambiar and William J. Rodriguez edited by Sumner J. Yaffe and Jacob V. Aranda.
    Published Nov 1, 2010
  9. Additional Protections for Children Enrolled in Clinical Investigations. Pages 81-102 in Pediatric Drug Development: Concepts and Applications,
    by Robert “Skip” Nelson” edited by Andrew E. Mulberg, Steven Silber, and John N. van den Anker.
    ISBN: 978-0-470-16929-2, Hardcover, 683 pages, April 2009, Wiley-Blackwell.
  10. Labeling of Pediatric Pain Medications In "Pain in Children: A Practical Guide for Primary Care,”
    Hari Cheryl Sachs, MD, FAAP, Debbie Avant, R.Ph, and William Rodriguez, MD, PhD, Editor Gary A. Walco, PhD and Kenneth R. Goldshneider, MD
    Published by Humana Press, July 2008
  11. Pharmacovigilance in Pediatrics.
    Solomon Iyasu, MD, MPH and Dianne Murphy, MD in Pharmacovigilance, 2nd Edition, Editors: R.D. Mann and Andrews.
    Published by Wiley & Sons, January 2007
  12. Pediatric Medical Device Use.
    Judith Cope, MD, MPH and Thomas Gross, MD, MPH.
    Chapter 15: Medical Device Epidemiology and Surveillance. Pgs 203-218. Editors:Brown SL, Bright RA, Tavris DR.
    Published by Wiley & Sons, Ltd., 2007.
  13. Ethics and the Pharmaceutical Industry.
    M. Dianne Murphy and Sara F. Goldkind
    Chapter 3: Regulatory and Ethical Challenges of Pediatric Research, Pgs 48-67
    Editors: Michael A. Santoro and Thomas M. Gorrie- Published by Cambridge University Press, 2007

C. COMMUNICATIONS:

Editorials

  1. Letter to the Editor: Re: Discontinuation and Nonpublication of Randomized Clinical Trials in Childrendisclaimer icon
    Mary Dianne Murphy, MD
    Pediatrics. August 24, 2016
  2. Letter to the Editor: Pediatric Product Development is Different: Extrapolation and Web posted Study Reviewsdisclaimer icon
    Dianne Murphy, MD, Lynne Yao, MD, Haihao Sun, MD, PhD
    BMJ October 10, 2015
  3. Outreach Initiative for FDA Pediatric Web Links. Completing a multi-year effort to have major pediatric texts and handbooks incorporate links to FDA-pediatric product information.
    AAP Red Book, Johns Hopkins Harriet Lane Handbook, and Nelson’s Pediatric Antimicrobial Therapy Pocket Book. August 8, 2014
     
  4. Letter to the Editor: Why Any Analysis of Infant Formula Effects on Infant Visual Acuity Performed Before the Age of 7 Years is Not Likely Predictive.disclaimer icon
    Wiley A. Chambers, MD, Dianne Murphy, MD, William Rodriguez, MD, PhD, Hiahao Sun, MD, PhD
    Pediatrics. February 11, 2013
  5. Time for a focus on pediatric friendly formulationsdisclaimer icon
    Mansoor A. Khan, PhD RPh and William Rodriguez, MD PhD
    Infectious Diseases in Children. June 2011
  6. Children Neglected in Clinical Drug Trials.disclaimer icon Perspective
    by Benjamin Ortiz, MD
    Infectious Diseases in Children. 2012 June; 24 (6)
  7. Letter to the Editor: The Globalization of Pediatric Trials: Should We be Worried? disclaimer icon
    Julia Dunne, Dianne Murphy, Gerold Wharton
    Pediatrics October 6, 2010

D. POSTERS:

  1. Lessons Learned from Literature and Randomized Clinical Trial (RCT) Review of Serious Adverse Events (SAE) in Children, using Lamotrigine as an Example.
    Haihao Sun, Renan A. Bonnel, Ann W McMahon.
    Presented on May 2, 2016, at the Pediatric Academic Society meeting in Baltimore, MD
  2. Databases Available for Pediatric Pharmacoepidemiology.
    Ann McMahon.
    Presented on August 22, 2015, at the Annual Meeting of the International Society of Pharmacoepidemiology (ISPE) in Boston, MA.
  3. Stratification, Hypothesis Testing, and Clinical Trial Simulation in Pediatric Drug Development.
    Ann McMahon.
    Presented on August 25, 2015, at at the Annual Meeting of the International Society of Pharmacoepidemiology (ISPE) in Boston, MA.
  4. Medication exposures and subsequent development of Ewing sarcoma: A review of FDA adverse event reports.
    Cope JU, Reaman G, Tonning J.
    Presented on April 18-22, 2015, at the American Association of Cancer Research Annual Meeting, Philadelphia, PA.
  5. Large sample size versus detailed data collection: Strengths of observational versus chart review studies for pediatric drug safety.
    McMahon AW, Wharton GT, Testoni D, Clark RH, Hornik CP, Smith PB, Abrams B, Damilano CP, DeLeon D, Lieu P, Yen L, Taketomo C, Thornton PS, Sood B, Doe E, Rodriguez W, Murphy MD
    Presented on May 3-5, 2014, Pediatric Academic Society (PAS) meeting in Vancouver, Canada.
  6. Efficacy Endpoint and Clinical Trials Are Needed for Pulmonary Arterial Hypertension (PAH) in Children and Neonates.
    Haihao Sun MD, Norman Stockbridge, MD, Dianne Murphy, MD; Ronald Ariagno, MD; William J. Rodriguez, MD, PhD; and Debbie Avant, RPh
    Presented on May 3-5, 2014, Pediatric Academic Society (PAS) meeting in Vancouver, Canada.
  7. How can pediatric pharmacoepidemiology make a difference to you: stake holder perspectives: Food and Drug Administration.
    McMahon AW.
    Presented in April 2014, Mid-year International Society for Pharmacoepidemiology Meeting, Rotterdam, The Netherlands.
  8. Safety of asthma drugs in children.
    McMahon AW.
    Presented in April 2014, Mid-year International Society for Pharmacoepidemiology Meeting, Rotterdam, The Netherlands.
  9. Need Validated Study Outcome Measures for Docosahexanoic and Arachidonic Acids (DHA & ARA) Supplemented Infant Formula Trials: Call to Tackle Non-Validated Endpoint Issues.
    Haihao Sun, MD, PhD; Peter Como, PhD; Brian Smith, MD, MPH, MHS; William J. Rodriguez, MD, PhD; and Dianne Murphy, MD
    Presented on March 21, 2014, Eastern Society for Pediatric Research (ESPR) meeting in Philadelphia, PA
  10. Pediatric Therapies: Post-marketing Safety Reviews.
    Judith U. Cope, MD, MPH, Dianne Murphy, MD, Amy Odegaard, MPH, Pamela Weinel, MS, MBA, RN
    Presented on May 5, 2013, Pediatric Academies Society (PAS) meeting in Washington D.C
  11. Off-Label Use of Octreotide in Infants.
    Ann W McMahon, Suzanne Treadway, Pamela Weinel, Cecilia P. Damilano, Phuong Lieu, Lilly Yen, Judith Cope, Marilyn Flack, Suzanne Rich and M.Dianne Murphy
    Presented on August 17, 2012 at the Annual Meeting of the International Society of Pharmacoepidemiology (ISPE) in Barcelona, Spain.
  12. Review of Alternate Endpoints and Activity Indices Used in the Pediatric Ulcerative Colitis Registration Trials.
    Haihao Sun, MD PhD, Catherine S Lee, DrPH, Jessica J Lee, MD, Robert M Nelson, MD PhD, Hari C Sachs, MD, William J Rodriguez, MD PhD and Andrew E Mulberg, MD
    Presented on April 30, 2012 Pediatric Academic Society (PAS) meeting in Boston.
  13. Pediatric Use of Insulin Pump Technology: A Food and Drug Administration Retrospective Study of Adverse Events in Children Ages 1-12 years.
    Judith U. Cope, MD, MPH, Joy H. Samuels-Reid, MD, Audrey E. Morrison, RN
    Presented on April 20-21, 2012 at International Clinical Diabetes and Technology meeting in Los Angeles.
  14. Extrapolating Efficacy, Maximizing the Use of Adult & Other Data in Pediatric Drug Development.
    Julia Dunne, William Rodriguez, Dianne Murphy, Nhi Beasley, Gilbert Burckhart, Jane Filie, Linda Lewis, Hari Sachs, Philip Sheridan, Peter Starke and Lynne Yao
    Presented on April 30, 2011, Pediatric Academic Society (PAS) meeting.

Work involving the Duke IPA faculty is identified by an *.

** A copy can be requested from Office of Pediatric Therapeutics.


 

 

 

 

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