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Addressing the Barriers to Pediatric Drug Development Workshop Summary (2008) / Chapter Skim
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5 Challenges and Opportunities for the Future
Pages 36-40

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From page 36...
... Murphy offered several suggestions for improving the system for pediatric drug research: • More transparency in research • Continued development of pediatric endpoints and assessment tools • Real-time inspections of pediatric trials • Continued development of juvenile animal models • Better approaches to assessing the long-term safety of drugs • Active surveillance systems focused on pediatric populations • More studies in neonates and premature infants Dr. Murphy asserted that pediatric drug development must become more global because pediatric populations are smaller than the adult 36
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From page 37...
... It needs to encompass adverse events as well as other outcomes and to quantify long-term benefit. Dr. Fleischman suggested that the only way to make postmarket surveillance feasible is to support the development of uniform electronic medical records with appropriate privacy protections.
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From page 38...
... Dr. Patricia Horsham, a member of the audience from the College of Physicians and Surgeons in Canada, noted that drug companies are approaching pediatricians in private practice to recruit patients for clinical trials so they will not have to deal with the stringent rules for academic research.
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From page 39...
... Many participants agreed that incentives work, but perhaps more are needed. Additional incentives worth exploring are limited liability, incentives to work on formulation and taste issues to improve pediatric patient adherence, and debt forgiveness for students entering academic careers in pediatrics and clinical investigation.
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From page 40...
... In addition to better training, increasing the numbers of trained pediatric clinical investigators is also important; the debt forgiveness for students incentive mentioned earlier could be helpful in this regard. Pediatric-specific adverse events must also be defined so that pediatricians and parents will know what to look for and how to manage events that occur.
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Key Terms

  • drug development
  • adverse events
  • pediatric populations
  • pediatric studies
  • pediatric drugs

  • pediatric research
  • clinical trials
  • drug studies
  • combining incentives
  • active surveillance

  • debt forgiveness
  • pediatric clinical
  • trained pediatric
  • pediatric patient
  • conducting pediatric

  • clinical drug
  • pediatric formulations
  • pediatric applications
  • improve pediatric
  • pediatric indication

  • move pediatric
  • medications properly
  • snodgrass responded
  • reviews adverse
  • postmarket surveillance

  • medical records
  • charitable contributions
  • participants discussed
  • proper auspices
  • drug safety


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