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:3/3/2015)... Today is International Ear Care Day, ... occasion to applaud and promote the launch of Make ... Organization (WHO) for stemming the threat of noise-induced hearing ... people to practice safe listening when they recreate, be ... sporting events, or engaging in other forms of entertainment. ...
(Date:3/3/2015)... The number of couples experiencing infertility in Canada ... increases to 50% by the time a woman is ... et al. Estimating the prevalence of infertility in Canada. ... reproductive endocrinologist and co-director at Olive Fertility Centre, and ... and founder of Acubalance Wellness Centre will be speaking ...
(Date:3/3/2015)... 2015 -- vRad ( Virtual Radiologic ), the nation’s ... Arlene Sussman, MD, a highly regarded breast imaging and ... explore how telemedicine best practices allow for the access ... virtually anywhere. Click here to register for ... 4, 2015 at 1:00 pm CT. , Hospitals must ...
(Date:3/3/2015)... Dallas, Texas (PRWEB) March 03, 2015 ... will serve as chairman of the upcoming Dallas Rhinoplasty ... 2015. The three day symposium, which is attended by ... designed to provide surgeons with detailed information on current ... and revision rhinoplasty surgery . , The ...
(Date:3/3/2015)... 3, 2015) (PRWEB) March 03, 2015 ... an innovator in the travel industry for the past ... expansion plan. To fulfill his vision for the future ... 400 fun, exciting and well-compensated positions as travel sales ... news sales center planned for the Boynton Beach, Florida ...
Breaking Medicine News(10 mins):Health News:ASHA Applauds Launch of New WHO Campaign 2Health News:New Treatment Approach Helps Boost Chance of Pregnancy; Information Seminar at Olive Fertility Center 2Health News:New Treatment Approach Helps Boost Chance of Pregnancy; Information Seminar at Olive Fertility Center 3Health News:New Treatment Approach Helps Boost Chance of Pregnancy; Information Seminar at Olive Fertility Center 4Health News:Latest vRad Webinar: Building World-Class Breast Imaging Services Virtually Anywhere with Telemedicine Best Practices 2Health News:Latest vRad Webinar: Building World-Class Breast Imaging Services Virtually Anywhere with Telemedicine Best Practices 3Health News:Latest vRad Webinar: Building World-Class Breast Imaging Services Virtually Anywhere with Telemedicine Best Practices 4Health News:Dr. Rod Rohrich to Chair 32nd Annual Dallas Rhinoplasty Symposium 2Health News:Dr. Rod Rohrich to Chair 32nd Annual Dallas Rhinoplasty Symposium 3Health News:First Class Vacations, Inc. Expansion Plan Creates 400 Jobs In South Florida 2Health News:First Class Vacations, Inc. Expansion Plan Creates 400 Jobs In South Florida 3
... doses of daily caffeine during pregnancy whether from ... an increased risk of miscarriage, according a new study ... controlled, for the first time, pregnancy-related symptoms of nausea, ... the determination of caffeines true effect on miscarriage risk. ...
... DALLAS Jan. 21, 2008 Findings by UT ... the potential benefits and side effects of the drug ... In todays online issue of Cancer, UT ... Institutes Prostate Cancer Prevention Trial, or PCPT. The trial, ...
... 1.5 million Americans, most of them women, suffer from ... the bodys own tissue. This week marks a significant ... the online publication of four new studies identifying genes ... Mary K.Crow, M.D., associate chief of the division of ...
... To Make Global Inroads ... on Decreasing Deaths from the Disease, DALLAS, Jan. 20 ... network of breast cancer survivors and,activists, this week welcomes a ... for a five-day intensive training of,trainers session called Course for ...
... route and available for comment, STAMFORD, Conn., Jan. ... medical supplies to Kenya in response,to the upheaval following ... over 600 people have been killed and over 250,000,have ... is due to,arrive on Saturday (January 19) and will ...
... added pressure on joints, study suggests , , FRIDAY, ... with osteoarthritis may also play a role in determining ... The findings, which included an analysis of the genomes ... a number of reasons, said study co-leader Goncalo Abecasis, ...
Cached Medicine News:Health News:New Kaiser Permanente study fortifies caffeine's link to miscarriage 2Health News:New Kaiser Permanente study fortifies caffeine's link to miscarriage 3Health News:Pros, cons of drug proven to prevent prostate cancer should be considered, researchers recommend 2Health News:NEJM editorial on significance and limitations of new lupus gene expression research 2Health News:NEJM editorial on significance and limitations of new lupus gene expression research 3Health News:NEJM editorial on significance and limitations of new lupus gene expression research 4Health News:Susan G. Komen for the Cure Sharing Grassroots Advocacy Knowledge With International Representatives in Intensive Dallas Training Session 2Health News:Susan G. Komen for the Cure Sharing Grassroots Advocacy Knowledge With International Representatives in Intensive Dallas Training Session 3Health News:Genes Linked to Height Also Tied to Osteoarthritis Risk 2
(Date:3/3/2015)... AUSTIN, Texas , March 3, 2015  UnaliWear ... that provides advanced support for seniors that guards against ... The new wearable – the Kanega ... of its kind to use an easy speech interface ... update medical information without human input. ...
(Date:3/3/2015)... , March 3, 2015 Konica Minolta ... announced today a new, integrated portable X-ray ... solution is now available with a larger integrated console, ... mounted system offers a larger viewing area to simplify ... provides additional space for accessories and storage, along with ...
(Date:3/3/2015)... , March 3, 2015 Frost ... recognized world-class manufacturing companies and individual leaders ... Awards. Logo - http://photos.prnewswire.com/prnh/20150303/179222LOGO ... intensifying global competition and accelerating, technology-driven change, ... themselves by embracing breakthrough innovation and enabling ...
Breaking Medicine Technology:UnaliWear's Wearable For Seniors Extends Independence With Advanced Technology 2Konica Minolta Medical Imaging and Shimadzu Medical Systems USA Introduce MobileArt Evolution EFX AeroDR-i with 17" Touch Monitor to Simplify Operation 2Konica Minolta Medical Imaging and Shimadzu Medical Systems USA Introduce MobileArt Evolution EFX AeroDR-i with 17" Touch Monitor to Simplify Operation 32015 Manufacturing Leadership Award Winners Announced 22015 Manufacturing Leadership Award Winners Announced 32015 Manufacturing Leadership Award Winners Announced 42015 Manufacturing Leadership Award Winners Announced 52015 Manufacturing Leadership Award Winners Announced 6
... UCB, Inc. today announced an agreement with the U.S. ... investigation into the marketing and promotion of Keppra®, an anti-epileptic ... subject of this investigation occurred more than six years ago, ... with the United States since learning of the investigation in ...
... hoc analysis from the RECOVER study (Randomized Evaluation of ... that patients with Parkinson,s disease who used Neupro® (rotigotine ... mood/cognition, such as taking interest in surroundings and getting ... presented from a one year open label follow-up of ...
Cached Medicine Technology:UCB, Inc. Resolves Investigation of Past Keppra® Marketing and Promotional Activities 2Post Hoc Analysis from RECOVER Study Examined Effects of Neupro® (Rotigotine Transdermal System) on Surrogate Markers of Mood and Anhedonia in Parkinson's Disease 2Post Hoc Analysis from RECOVER Study Examined Effects of Neupro® (Rotigotine Transdermal System) on Surrogate Markers of Mood and Anhedonia in Parkinson's Disease 3Post Hoc Analysis from RECOVER Study Examined Effects of Neupro® (Rotigotine Transdermal System) on Surrogate Markers of Mood and Anhedonia in Parkinson's Disease 4Post Hoc Analysis from RECOVER Study Examined Effects of Neupro® (Rotigotine Transdermal System) on Surrogate Markers of Mood and Anhedonia in Parkinson's Disease 5Post Hoc Analysis from RECOVER Study Examined Effects of Neupro® (Rotigotine Transdermal System) on Surrogate Markers of Mood and Anhedonia in Parkinson's Disease 6
... Ultra device consists of a non-compliant balloon ... mounted longitudinally on its outer surface. When ... the atherotomes score the plaque, creating initiation ... to as Atherotomy, allows dilatation of the ...
... Millar Mikro-Tip pressure intravascular catheters provide ... method of measuring pressures in the ... thromboresistant Mikro-Tip catheters are ideal for ... range in size from 2 to ...
... pressure intravascular catheters provide a simple, ... measuring pressures in the heart or ... catheters are ideal for high fidelity ... size from 2 to 7 French ...
... Millar Mikro-Tip pressure intravascular catheters provide ... method of measuring pressures in the ... thromboresistant Mikro-Tip catheters are ideal for ... range in size from 2 to ...
Medicine Products: