The Principle of Equipoise in Pediatric Drug Trials

2014 ◽  
Vol 17 (1) ◽  
pp. 17-21 ◽  
Author(s):  
Kim Chau ◽  
Gideon Koren
Keyword(s):  
Drug Trials ◽  
Pediatric Drug

Limited Capacity in US Pediatric Drug Trials

2011 ◽  
Vol 13 (2) ◽  
pp. 119-124 ◽  
Author(s):  
Richard Wasserman ◽  
Alison Bocian ◽  
Donna Harris ◽  
Eric Slora
Keyword(s):  
Limited Capacity ◽  
Drug Trials ◽  
Pediatric Drug

Poor Formulation Information in Published Pediatric Drug Trials

PEDIATRICS ◽  
2005 ◽  
Vol 116 (4) ◽  
pp. e559-e562 ◽  
Author(s):  
J. F. Standing
Keyword(s):  
Drug Trials ◽  
Pediatric Drug

Pediatric Drug Trials

2010 ◽  
Vol 6 (4) ◽  
pp. 300-301
Author(s):  
Maren S. Mayhew
Keyword(s):  
Drug Trials ◽  
Pediatric Drug

Challenges in conducting pediatric drug trials

2000 ◽  
Vol 106 (3) ◽  
pp. S125-S127 ◽  
Author(s):  
Cheston M. Berlin
Keyword(s):  
Drug Trials ◽  
Pediatric Drug

PEDIATRIC DRUG TRIALS IN CHINA

2015 ◽  
Vol 101 (1) ◽  
pp. e1.12-e1
Author(s):  
Guo-Xiang Hao ◽  
Xiao-Ling Wang ◽  
A-Dong Shen ◽  
Evelyne Jacqz-Aigrain ◽  
Wei Zhao
Keyword(s):  
Drug Development ◽  
Pediatric Population ◽  
Drug Trials ◽  
The European Union ◽  
Trial Registry ◽  
Pediatric Drug ◽  
Population Number ◽  
Pediatric Drug Development ◽  
Number Of Patients ◽  
Registry Database

Background and objectiveThe introduction of the Pediatric Regulation by the European Union, together with the renewal of the Pediatric Rule by the US Food and Drug Administration on the requirements for pediatric labeling made it mandatory for sponsors to develop drugs for the pediatric population and promotes the pediatric drug trials in Europe and US. However, very little is known about the situation of pediatric drug trials in other countries, particularly in China, home to nearly 300 millions children. In order to support the global research in pediatric drug development and clarify the specific characteristics of pediatric drugs trials in China, we analyzed the drug trials registered in the Chinese Clincial Trial Registry database.MethodsThe pediatric drug trials registered in Chinese Clincial Trial Registry database between 2007 and 2014 were analyzed. The following information was extracted from the database by two authors: type of the trial, registered time, drug name, inclusion and exclusion criteria, population, number of patients, and sponsor.ResultsAmong all (4786) trials registered, 729 trials (15.2%) involved the pediatric population, and only 308 trials (6.4%) were pediatric drug trials. From 2007 to 2013 pediatric drug trials increased from 3 to 121. There were 66 pediatric drug trials including Chinese traditional medicine.ConclusionOur results demonstrated for the first time the situation of pediatric drug trials in China. Consistent with the initiatives of promoting pediatric drug development in Europe and US, the pediatric drug trial in China made a significant progress after 2012. The pediatric drug legislation is urgently needed in China.

Changing the Outcomes of Pediatric Drug Trials: APNs Making a Difference

2013 ◽  
Vol 27 (3) ◽  
pp. 222-225 ◽  
Author(s):  
Michelle Dickey ◽  
Peggy Clark
Keyword(s):  
Drug Trials ◽  
Pediatric Drug ◽  
Making A Difference

scholarly journals Pediatric Drug Trials Facing Some Obstacles

2005 ◽  
Vol 97 (23) ◽  
pp. 1720-1721 ◽  
Author(s):  
Joel B. Finkelstein
Keyword(s):  
Drug Trials ◽  
Pediatric Drug

PEDIATRIC DRUG TRIALS: Challenge to FDA's Authority May End Up Giving It More

Science ◽  
2002 ◽  
Vol 296 (5569) ◽  
pp. 820-821 ◽  
Author(s):  
E. Marshall
Keyword(s):  
Drug Trials ◽  
Pediatric Drug
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