The ‘Little Adults’ Myth: Why Pediatric Trials Are a Different Ball Game
When it comes to clinical trials, children are not just ‘small adults.’ This article provides a comprehensive look into the unique challenges and ethical considerations that come with pediatric trials.
The Source Article Details
Clinical trials in children by Pathma D Joseph et al. in 2015.
Cited By: 217 (Updated: December 4, 2023)
The Source Article's Abstract
The Source Article References
- An update on the therapeutic orphan by Wilson JT, 1999 in Pediatrics
- Editorial comment: therapeutic orphans by Shirkey H, 1999 in J Pediatr
- Is pediatric labeling really necessary? by Christensen ML, 1999 in Pediatrics
- From the E-ferol tragedy by Balistreri WF, 1986 in Pediatrics
- Clinical trial disclosure: global overview and implications of new laws and guidelines by Thomas-Urban KB, 2010 in Drug Inf J
- European and non-European paediatric clinical trials by Deal G, 2009 in Regul Rapportteur
- Clinical research in pediatric nephrology: challenges, and strategies to address them by Foster BJ, 2009 in J Nephrol
- Parents' attitudes to randomised controlled trials involving children by Caldwell PHY, 2003 in J Pediatr
- Readability of pediatric biomedical research informed consent forms by Tarnowski KJ, 2007 in Pediatrics
- Pediatric clinical trials: a worldview by Smit-Marshall P, 2010 in Appl Clin Trials
- Paediatric clinical research manual by Brooke A, 2006 in Arch Dis Child
Citing the Source Article (APA)
Joseph, P.D., Craig, J.C., Caldwell, P.H.Y. (2015). Clinical trials in children. British journal of clinical pharmacology, 79(3), 357-369. 10.1111/bcp.12305
Why Pediatric Trials Are Essential
Children have been historically underrepresented in clinical trials, leading to a lack of data that could improve their healthcare. The article emphasizes the significant advances in child health that have resulted from pediatric trials, such as the near-eradication of polio.
However, the article also points out that the number of pediatric trials has not seen a proportional increase over the years despite children making up about 27% of the world’s population.
Unique Challenges in Pediatric Trials
- Physiological Differences: Children metabolize medicines differently, leading to unexpected responses and adverse effects.
- Ethical Concerns: The ethical considerations are more complex, especially regarding informed consent and the use of placebos.
- Funding: Pediatric trials often rely on non-profit organizations for funding, as the pharmaceutical industry is less inclined to invest.
Implications for the Medical Profession
The article calls for a more robust approach to pediatric trials, emphasizing the need for specialized methodologies and ethical frameworks. It also highlights the importance of international collaboration to pool data and resources.
Given the unique challenges and high stakes, the medical community must prioritize pediatric trials to ensure children benefit from the latest medical advancements.
We’ve delved into the complexities and necessities of pediatric trials. What are your thoughts on this? Are we doing enough to include children in the narrative of medical research?
Feel free to leave a comment below.