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Clinical Trials

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...

Pharmacokinetics in Pediatric Patients: Drug Metabolism

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...

Clinical Trials: Overview

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...

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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,...

Blinding

Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.

Pharmacokinetics in Pediatric Patients: Drug Distribution

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,...

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Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting

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Published on: June 6, 2020

Patient and Public Involvement in Paediatric Pragmatic Randomized Controlled Trials: A Mixed Methods Study.

Shelley Vanderhout^1,2, Shipra Taneja¹, Pascale Nevins³

¹Institute for Better Health, Trillium Health Partners, Mississauga, ON L5B 1B8, Canada.

Children (Basel, Switzerland)

|December 30, 2025

Summary

This summary is machine-generated.

Patient and public involvement (PPI) in paediatric pragmatic trials enhances research relevance and quality. However, insufficient resources and time pose challenges, necessitating greater investment in PPI partnerships.

Keywords:

patient and public involvement patient engagement pragmatic trials

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Area of Science:

Clinical Trials
Paediatric Research
Health Services Research

Background:

Patient and public involvement (PPI) can improve the relevance and impact of pragmatic trials.
The extent and nature of PPI in paediatric pragmatic trials are not well understood.
This study investigates PPI in paediatric pragmatic trials and researchers' experiences.

Purpose of the Study:

To examine the prevalence and nature of PPI in paediatric pragmatic trials.
To identify lessons learned from researchers involved in PPI in paediatric trials.
To understand the perceived impacts and challenges of PPI in this context.

Main Methods:

Mixed-methods study combining an online survey and semi-structured interviews.
Targeted MEDLINE search to identify published paediatric pragmatic trials.
Descriptive statistics and qualitative thematic analysis of collected data.

Main Results:

56% of surveyed authors reported PPI in their paediatric pragmatic trials.
PPI was associated with more feasible interventions, higher research quality, and improved recruitment.
Challenges included insufficient resources, time, and training for developing PPI relationships.

Conclusions:

PPI is congruent with the goals of pragmatic trials, enhancing research quality and dissemination.
Paediatric researchers recognize the value of PPI for trial impact.
Increased institutional and funding support is crucial for successful PPI partnerships in paediatric research.