Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Clinical trials in children: problems and pitfalls.

R E Kauffman1

  • 1Children's Mercy Hospital and University of Missouri-Kansas City, 64108, USA. rkauffman@cmh.edu

Paediatric Drugs
|December 29, 2000
PubMed
Summary

New initiatives are boosting pediatric clinical trials, but ethical considerations and age-appropriate research designs are crucial. Ensuring children benefit equally from medical advances requires careful planning and ethical oversight in pediatric drug development.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Information at the point of care: effect on patient care and resource consumption.

Journal of healthcare information management : JHIM·2007
Same author

Clinical research involving children.

Bioethics forum·2002
Same author

Theophylline toxicokinetics in premature newborns.

Archives of pediatrics & adolescent medicine·2001
Same author

A randomized comparison of ketorolac tromethamine and morphine for postoperative analgesia in critically ill children.

Critical care medicine·2000
Same author

Rifapentine pharmacokinetics in adolescents.

The Pediatric infectious disease journal·1999
Same author

Essential drugs for infants and children: North American perspective.

Pediatrics·1999

Area of Science:

  • Pediatric Pharmacology
  • Clinical Trial Design
  • Regulatory Science

Background:

  • Recent US legislative and regulatory actions have significantly incentivized the development of new drugs for pediatric populations.
  • There is a growing global emphasis on pediatric pharmaceutical development, evidenced by international guidelines like those from the International Conference on Harmonisation.

Purpose of the Study:

  • To examine the impact of recent initiatives on pediatric clinical trials.
  • To highlight the ethical considerations and methodological adaptations necessary for pediatric research.
  • To advocate for the successful and ethical execution of clinical studies for the benefit of children.

Main Methods:

  • Analysis of trends in pediatric clinical trial initiation and growth.
  • Review of regulatory incentives and international guidelines impacting pediatric drug development.
  • Discussion of ethical imperatives and adaptive trial design principles for pediatric populations.

Main Results:

  • A notable increase in the number of pediatric clinical trials conducted in the US.
  • Growing international interest and harmonization efforts in pediatric pharmaceutical research.
  • Recognition of challenges faced by industry, regulators, and investigators in meeting increased demands.

Conclusions:

  • Ethical issues unique to children must be prioritized in the evolving landscape of pediatric clinical research.
  • The adult research model is not directly transferable to pediatric studies; age-appropriate protocols are essential.
  • Continued successful and ethical clinical studies in children are vital to ensure they benefit from therapeutic advancements.

Related Experiment Videos