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Related Concept Videos

Clinical Trials01:16

Clinical Trials

10.9K
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...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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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...
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Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

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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...
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Preclinical Development: Overview01:28

Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
6.1K
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

353
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...
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Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

276
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...
276

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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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EAP viewpoint on unpublished data from paediatric clinical trials.

L Schrier1, K Illy2, A Valiulis3

  • 1Department of Paediatrics, Willem Alexander Children's Hospital, Leiden University Medical Center, Leiden, The Netherlands. l.schrier@lumc.nl.

European Journal of Pediatrics
|September 7, 2017
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Summary

Publication bias in paediatric randomized controlled trials (RCTs) is a significant issue, delaying data sharing and potentially skewing treatment evidence. The European Academy of Paediatrics (EAP) advocates for timely, complete data dissemination to ensure ethical research and reliable clinical information.

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Area of Science:

  • Clinical Trials
  • Publication Ethics
  • Paediatric Research

Background:

  • Paediatric randomised controlled trials (RCTs) data publication is crucial for European children and healthcare providers.
  • Selective publication and reporting of paediatric RCTs are prevalent, with industry-sponsored trials facing delays and non-publication.
  • Publication bias leads to research inefficiencies, resource waste, and distorted evidence for paediatric treatments.

Purpose of the Study:

  • To highlight the problem of selective publication in paediatric RCTs.
  • To emphasize the ethical and practical implications of publication bias in paediatric research.
  • To advocate for improved data dissemination practices in paediatric clinical trials.

Main Methods:

  • Analysis of publication practices for paediatric randomised controlled trials.
  • Review of factors influencing the timeliness and completeness of trial data publication.
  • Assessment of the impact of publication bias on research integrity and resource allocation.

Main Results:

  • Paediatric RCTs data publication is often selective and delayed.
  • Industry-sponsored trials exhibit a higher likelihood of delayed or non-publication compared to other sponsors.
  • Publication bias negatively impacts research efficiency and the reliability of evidence-based paediatric medicine.

Conclusions:

  • The European Academy of Paediatrics (EAP) supports initiatives promoting public dissemination of paediatric clinical trial data.
  • EAP will enhance awareness of Good Publication Practice guidelines among European paediatricians and societies.
  • Addressing publication bias is essential for ethical research and evidence-based paediatric care.