Related Experiment Video

Updated: Aug 29, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
00:04

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Pediatric clinical trial experience: government, child, parent and physician's perspective

Juan C Salazar1

  • 1Department of Pediatrics, University of Connecticut Medical School, Hartford, USA. jsalaza@ccmckids.org

The Pediatric Infectious Disease Journal
|December 23, 2003
PubMed

Insights

Pediatric drug investigations through clinical trials are increasing due to legislation. Careful dialogue ensures children

Area of Science:

  • Pediatric pharmacology and clinical trial methodology.
  • Regulatory science and ethical considerations in human research.

Background:

  • Historically, clinical trials in pediatric populations have been significantly underrepresented compared to adults.
  • Limited pharmaceutical industry incentives previously hindered pediatric drug development.
  • Recent government legislation has spurred increased research into drug efficacy and safety for children.

Purpose of the Study:

  • To summarize diverse perspectives on conducting clinical trials in children.
  • To highlight the importance of ethical considerations and risk-benefit assessments in pediatric drug research.

Main Methods:

  • Review and synthesis of various viewpoints on pediatric clinical trials.
  • Examination of the roles of government, investigators, children, and guardians in the trial process.

Main Results:

  • Legislation in the late 1990s has promoted pediatric drug investigations.
  • Clinical trials in children yield crucial data on dosing, adverse reactions, and efficacy.
  • Effective trials necessitate open communication regarding benefits versus risks.

Conclusions:

  • Children now have greater access to novel medicines during development.
  • Protecting children from undue risk and ensuring their well-being remain paramount in clinical trials.
  • A collaborative approach involving all stakeholders is essential for ethical and successful pediatric drug development.

More Related Videos

Making MR Imaging Child's Play - Pediatric Neuroimaging Protocol, Guidelines and Procedure15:18

Making MR Imaging Child's Play - Pediatric Neuroimaging Protocol, Guidelines and Procedure

Published on: July 30, 2009

Related Concept Videos

Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
Pharmacokinetics in Pediatric Patients: Drug Distribution01:17

Pharmacokinetics in Pediatric Patients: Drug Distribution

Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight, compared...
Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses a challenge in...