Related Experiment Videos
Safety in paediatric clinical trials--a 7-year review
H M Sammons1, C Gray, H Hudson
1Academic Division of Child Health, The Medical School, University of Nottingham, Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3DT, UK. Helen.sammons@nottingham.ac.uk
Acta Paediatrica (Oslo, Norway : 1992)
|March 1, 2008
Summary
This study reviewed pediatric clinical trials, finding that 11% had moderate or severe adverse drug reactions (ADRs). Safety monitoring committees (SMCs) are crucial for all pediatric clinical trials to ensure patient safety.
Area of Science:
- Pediatric Clinical Trials
- Drug Safety Monitoring
- Adverse Drug Reactions
Background:
- The safety of pediatric clinical trials has been understudied.
- Understanding safety monitoring and adverse drug reactions (ADRs) in children is critical.
Purpose of the Study:
- To investigate safety monitoring practices in pediatric clinical trials.
- To determine the incidence and severity of adverse drug reactions (ADRs) in children.
Main Methods:
- Literature review of Medline Database for therapeutic clinical trials in children (1996-2002).
- Analysis of papers to identify safety monitoring and adverse events (AEs) or ADRs.
Main Results:
- 739 trials reviewed; only 2% had safety monitoring committees (SMCs).
- 71% reported AEs, 20% reported serious AEs; 36.5% reported ADRs, with 11% moderate/severe.
- 6 trials terminated due to toxicity (all had SMCs); 11% of trials reported deaths.
Conclusions:
- Approximately 11% of pediatric clinical trials experience moderate to severe ADRs.
- Implementation of safety monitoring committees (SMCs) is recommended for all pediatric clinical trials.
Related Concept Videos
01:26Pharmacokinetics 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...
01:16Clinical 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...
There are four phases in a clinical trial. A phase one...
01:23Pharmacokinetics 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...
01:17Pharmacokinetics 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...
01:24Pharmacokinetics 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...
01:11Clinical 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...