Related Experiment Video

Updated: Nov 21, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

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

Published on: September 20, 2019

11.0K

The general data protection regulation, the clinical trial regulation and some complex interplay in paediatric

H W Dalrymple1

  • 1Centre For Pediatric Clinical Development, PRA Health Sciences, 500 South Oak Way, Green Park, Reading, RG2 6AD, UK. dalrympleharris@prahs.com.

European Journal of Pediatrics
|January 19, 2021
PubMed

Insights

Ensuring children's rights in clinical trials under the General Data Protection Regulation (GDPR) requires careful protocol drafting. This paper offers solutions for specific GDPR challenges in paediatric clinical trials.

Area of Science:

  • Clinical trial regulation
  • Paediatric research ethics
  • Data privacy law

Background:

  • The General Data Protection Regulation (GDPR) impacts clinical trial conduct.
  • Existing literature addresses GDPR in adult clinical trials.
  • Specific challenges of GDPR in paediatric trials remain underexplored.

Purpose of the Study:

  • To examine the impact of GDPR on paediatric clinical trials.
  • To identify unique GDPR considerations for minors in clinical research.
  • To propose practical approaches for ensuring children's rights under GDPR.

Main Methods:

  • Review of GDPR provisions relevant to clinical trials.
  • Analysis of age-related consent differences across jurisdictions.
  • Examination of protocol complexities in paediatric trials, including pregnancy scenarios.

Main Results:

  • Paediatric trials present distinct GDPR challenges compared to adult trials.
  • Discrepancies in age of consent for data privacy and trial participation exist.
  • Standard clinical trial protocols often fail to address specific GDPR requirements for minors.

Conclusions:

  • Conducting paediatric clinical trials in compliance with GDPR is feasible.
  • Careful protocol development is essential to navigate GDPR complexities.
  • The paper offers solutions for specific GDPR application scenarios in paediatric research.

Keywords:
CTRGDPRPaediatric clinical trials

More Related Videos

Working with Human Tissues for Translational Cancer Research07:48

Working with Human Tissues for Translational Cancer Research

Published on: November 26, 2015

10.2K
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

18.5K

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...
10.0K
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...
4.3K
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,...
130
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...
108
Preclinical Development: Overview01:28

Preclinical Development: Overview

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...
5.5K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
266