Navigation Links
Experts call for increased neonatal inclusion in pediatric drug trials
Date:10/25/2012

Cincinnati, OH, October 25, 2012 -- Clinical drug trials are a vital part of pharmaceutical manufacturers gaining approval for use by the U.S. Food and Drug Administration. A Commentary scheduled for publication in The Journal of Pediatrics assesses the issues surrounding the lack of clinical trials on medications used by children, most notably neonates, and how drug manufacturers and academic researchers could work together to create clinical trials that would benefit this underrepresented population.

Henry Akinibi, MD, and colleagues from Cincinnati Children's Hospital Medical Center and the University of Cincinnati believe that the lack of clinical drug trials for neonates is caused by many factors, including additional regulatory requirements, no adult equivalents of many neonatal diseases to gain a starting point, lack of financial incentives for pharmaceutical companies, and the unique physiology of neonates. As a result, many doctors prescribe adult-approved drugs for children in off-label and unapproved uses; unfortunately, without clinical trials, the safety of this practice often is unknown and could place neonates at risk for unknown complications.

Throughout the years, the federal government has created legislation in an attempt to gather more information on the medications prescribed for children; the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act were made permanent by Congress in August 2012. These types of legislation have led to over 400 pediatric drug-labeling changes since 1998. Because neonates were addressed in only 6% of these changes, they continue to be at risk for receiving ineffective medications, incorrect dosages, and developing unanticipated complications. Although these new laws now include a requirement that pharmaceutical manufacturers submit plans for pediatric studies at certain times in the drug-approval process (e.g., Phase 2), they do not require a neonatal inclusion. This is important because drawing conclusions from the results of drug trials in older children and applying them to neonates is not ideal and continues to leave this population at risk.

Indisputably, unstudied medications for neonates have played a major role in the positive outcomes and increased viability for infants born prematurely, and, overall, recent laws have resulted in great strides in pediatric trials. However, the neonatal population still lags in inclusion. Of over 120,000 studies at the National Institutes of Health clinical trials repository, only 0.6% involves neonates; in total, only 3.4% of all registered pediatric studies involve neonates. Open communication and cooperative sharing between industry and academics are integral components to ensuring that drugs are safe and effective for all populations. According to the first author of the article, Jason R. Wiles MD, "Inclusion of neonatologists and neonatal pharmacologists in study designs, and early in the drug development process, would make data generated from such studies more relevant and useful."


'/>"/>
Contact: Becky Lindeman
journal.pediatrics@cchmc.org
513-636-7140
Elsevier Health Sciences
Source:Eurekalert

Related medicine news :

1. Experts convene to address major cause of childhood illness and death
2. 4,000 analytics experts come to Phoenix for INFORMS Annual Meeting
3. Swallowed Toothpicks Can Lead to Big Trouble, Experts Warn
4. Lights off? International experts call attention to dangers of exposure to light at night
5. Put Traffic Safety on Back-to-School To-Do List: Experts
6. Experts Offer Tips to Help Keep Fall Sports Injury Free
7. Experts recommend screening adults for hypertriglyceridemia every five years
8. Alzheimers experts from Penn Summit provide strategic roadmap to tackle the disease
9. Experts warn that e-cigarettes can damage the lungs
10. Snoring Kids Should Be Screened for Sleep Apnea: Experts
11. Add Hurricane Menu to Your Storm Prep, Experts Say
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... , ... Ellevate Network, the leading network for professional women, brought together some ... at their inaugural Summit in New York City in June. The event was livestreamed ... over 3 million. To watch the Mobilize Women video, click here . ...
(Date:10/13/2017)... ... 13, 2017 , ... Coveros, a leader in agile coaching ... contract by the Center for Medicare and Medicaid Services (CMS). The Enterprise Agile ... of Agile methodologies in a consistent and high value manner across CMS programs. ...
(Date:10/12/2017)... ... 12, 2017 , ... CitiDent and San Francisco dentists, Dr. ... Oventus O2Vent technology. As many as 18 million Americans are estimated to suffer ... Oral appliances can offer significant relief to about 75 percent of people with ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... The American ... Excellence to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium ... 8. , In honor of Morris F. Collen, a pioneer in the field of ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader ... a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were ... 11, 2017. , The annual award competition recognizes editorial and design excellence across a ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... , Oct. 11, 2017  Hill-Rom Holdings, Inc. ("Hill-Rom") ... Surgical facility in Las Piedras, Puerto Rico ... and blades. ... the facility sustained minor structural damage, temporary loss of ... Repairs have been completed, manufacturing operations have resumed, and ...
(Date:10/4/2017)... , Oct. 4, 2017  South Korean-based healthcare product ... training aide "cprCUBE" on Kickstarter. The device will educate ... cardiac arrests with better efficiency compared to the dated ... real-time feedback on efficacy of the compression for a ... has a goal to raise $5,000. ...
(Date:10/2/2017)...  AllianceRx Walgreens Prime, the combined central specialty pharmacy ... benefit manager Prime Therapeutics LLC (Prime), today officially began ... unveiling of new signage at its headquarters in ... a few other company-owned facilities across the country. This ... of whom will begin to see the AllianceRx Walgreens ...
Breaking Medicine Technology: