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 inclusi
'/>"/>

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

Page: 1 2

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:1/22/2015)... (PRWEB) January 23, 2015 The U.S. ... R.Ph., DICVP, Director of Clinical Pharmacy Services at North ... the recipient of the 2015 Beal Award for Distinguished ... USP has relied on the contributions of volunteer experts ...
(Date:1/22/2015)... 22, 2015 Woodloch Pines, an all-inclusive ... selected by TripAdvisor as the number one best large hotel ... in the world for their annual Travelers’ Choice Awards. ... . The website is home to millions of unbiased and ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 The Incredible Bulk ... Ben Pakulski to increase lean muscle by up to 30lbs ... caught the attention of HealthyandFitZone.com’s Stan Stevenson, prompting an investigative ... it is a step-by-step, scientific diet formula that allows the ...
(Date:1/22/2015)... New York, New York (PRWEB) January 22, 2015 ... ( http://www.vaginalmeshlawsuit2015.com/ ) in the U.S. District Court, Southern District ... against C.R. Bard, Inc. in that proceeding’s first bellwether trial. ... defense request for a new trial after finding that C.R. ...
(Date:1/22/2015)... Autocarinsurancebest.com has released a new blog post ... insurance policy . , Auto insurance quotes help many ... no longer necessary to call an agent or visit an ... on a single website: http://autocarinsurancebest.com/ . , Every business ...
Breaking Medicine News(10 mins):Health News:Gigi Davidson, Pioneer in Veterinary Pharmacy and Leader in Pharmacy Compounding, honored with USP’s Beal Award for Dedication to Public Health 2Health News:Gigi Davidson, Pioneer in Veterinary Pharmacy and Leader in Pharmacy Compounding, honored with USP’s Beal Award for Dedication to Public Health 3Health News:Gigi Davidson, Pioneer in Veterinary Pharmacy and Leader in Pharmacy Compounding, honored with USP’s Beal Award for Dedication to Public Health 4Health News:TripAdvisor Names Woodloch Pines Best Hotel for Families in America 2Health News:TripAdvisor Names Woodloch Pines Best Hotel for Families in America 3Health News:The Incredible Bulk: Review Examining Ben Pakulski’s Brand New Bulking Muscle Building Diet Program Released 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 3Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 4Health News:Commercial Auto Insurance Provides Several Important Features! 2
... Initiative for Online Users to Learn about Each Candidate,s Health ... ... Miami, FL (PRWEB) August 28, 2008 -- ... provider search, announced today the launch of "HealthDecision ,08: Obama ...
... and March of Dimes Volunteer to take part in ... From Hell,s,Kitchen to a kitchen near you: Chef ... March of Dimes Signature Chef Auctions open to the ... of Dimes first national celebrity chef,spokesperson. In this role, ...
... Replidyne, Inc.,(Nasdaq: RDYN ) today announced ... headcount by approximately 80% to 5 employees in,actions ... 2008 and October,2008. As a result of these ... its investigational agent for the,treatment of Clostridium difficile ...
... VaxGen,Inc. (OTC Bulletin Board: VXGN), a biopharmaceutical ... the filing of its,quarterly report on Form 10-Q ... 2008., (Logo: http://www.newscom.com/cgi-bin/prnh/19991112/VAXGENLOGO ), VaxGen ... and,investment securities as of June 30th, 2008, or ...
... make insulin-resistant proteins, study says , , WEDNESDAY, Aug. 27 (HealthDay ... to those in lean people, a new study shows. ... a group of researchers from the Temple University School of ... lean and six obese people. , They found significant differences ...
... study finds , , WEDNESDAY, Aug. 27 (HealthDay News) -- ... dose chemotherapy lived longer and better by adding the ... , The finding could make multiple myeloma, a cancer ... a lethal disease. And it would be particularly valuable ...
Cached Medicine News:Health News:HealthCare.com Launches HealthDecision '08: Obama and McCain on Health Care 2Health News:HealthCare.com Launches HealthDecision '08: Obama and McCain on Health Care 3Health News:Chef Rock to Rock Signature Chefs Auctions(R) Nationwide 2Health News:Replidyne Announces Restructuring of Operations 2Health News:VaxGen Provides Financial Update Following the Filing of Its 10-Q for Second Quarter With SEC; Results Include $8.5 Million Charge in Respect of Manufacturing Plant Asset Impairment 2Health News:VaxGen Provides Financial Update Following the Filing of Its 10-Q for Second Quarter With SEC; Results Include $8.5 Million Charge in Respect of Manufacturing Plant Asset Impairment 3Health News:Combination Therapy Helps to Combat Myeloma 2Health News:Combination Therapy Helps to Combat Myeloma 3
(Date:1/22/2015)... , Jan. 22, 2015  Amgen (NASDAQ: AMGN ) ... year 2014 financial results on Tuesday, Jan. 27, 2015, after the ... by a conference call with the investment community at 2 p.m. ... A. Bradway , chairman and chief executive officer, and other members ...
(Date:1/22/2015)... 22, 2015  Profil Institute for Clinical Research, Inc., a ... announced today a new textbook,  Translational Research Methods for ... a leading global scientific publisher. The textbook ... for use in early phase clinical studies of new ...
(Date:1/22/2015)... , Jan. 22, 2015 Research and Markets ... "Infectious Disease Diagnostics Market by Product, Application, Technology, ... to their offering. , The infectious disease ... 7.9% to reach $18,156.2 million by 2019 from $12,422.8 ...
Breaking Medicine Technology:Amgen Announces Webcast of 2014 Fourth Quarter and Full Year Financial Results 2New Textbook "Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development" Provides Critical Review Of Current And Emerging Clinical Investigation Methods 2New Textbook "Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development" Provides Critical Review Of Current And Emerging Clinical Investigation Methods 3Global Infectious Disease Diagnostics (Instruments, Reagents, Services, Software) Market - Forecast to 2019 2Global Infectious Disease Diagnostics (Instruments, Reagents, Services, Software) Market - Forecast to 2019 3
... 5 ResMed Inc. (NYSE: RMD ), a ... medical equipment, announced today that it has acquired Laboratoires ... the Narval O.R.M.(TM), an innovative mandibular repositioning device (MRD) ... obstructive sleep apnea (OSA), especially for those with mild ...
... following letter is being released by CEL-SCI Corporation (NYSE ... Shareholders: , After FDA had communicated several weeks ago that ... proposed H1N1 treatment for hospitalized H1N1 patients, we have received ... mind, we have asked one of our outside collaborators, Ken ...
Cached Medicine Technology:ResMed Acquires Laboratoires Narval 2ResMed Acquires Laboratoires Narval 3CEL-SCI Corporation Releases Letter to Shareholders 2CEL-SCI Corporation Releases Letter to Shareholders 3CEL-SCI Corporation Releases Letter to Shareholders 4CEL-SCI Corporation Releases Letter to Shareholders 5CEL-SCI Corporation Releases Letter to Shareholders 6CEL-SCI Corporation Releases Letter to Shareholders 7
... AngioSpeed VH series, it is ... 2 independent C-arms and image ... dedicated for Cardiovascular and Angiography. ... perform the examinations for cerebral, ...
This catheter is intended for ultrasound examination of coronary intravascular pathology ONLY. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary i...
Rubidium Rb 82 Generator. ,The only generator-based Positron Emission Tomography agent reimbursed for the evaluation of coronary artery disease....
Kit for the Preparation of Technetium Tc 99m Teboroxime...
Medicine Products: