Unknown

Dataset Information

0

Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.

ABSTRACT: Recent regulatory initiatives in the United States of America and Europe have transformed the paediatric clinical trials landscape by significantly increasing capital investment and paediatric trial volume. The purpose of this manuscript was to review the impact of these initiatives on the paediatric cardiovascular trials landscape when compared with other paediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major paediatric cardiovascular trials so as to inform the optimal design and conduct of future trials in the field.

SUBMITTER: Hill KD 

PROVIDER: S-EPMC4591024 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

Json Xml
altmetric image

Publications

Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.

Hill Kevin D KD   Henderson Heather T HT   Hornik Christoph P CP   Li Jennifer S JS  

Cardiology in the young 20150801

Recent regulatory initiatives in the United States of America and Europe have transformed the paediatric clinical trials landscape by significantly increasing capital investment and paediatric trial volume. The purpose of this manuscript was to review the impact of these initiatives on the paediatric cardiovascular trials landscape when compared with other paediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major paediatric cardiovas  ...[more]

Similar Datasets

Unknown Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012.
| S-EPMC6248195 | biostudies-literature
Unknown Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.
| S-EPMC6526087 | biostudies-literature
Unknown Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012-2018.
| S-EPMC7572516 | biostudies-literature
Unknown Patient-Reported Outcomes in Pediatric Cancer Registration Trials: A US Food and Drug Administration Perspective.
| S-EPMC8755487 | biostudies-literature
Unknown Publication bias in antipsychotic trials: an analysis of efficacy comparing the published literature to the US Food and Drug Administration database.
| S-EPMC3308934 | biostudies-literature
Unknown Under-representation of elderly in clinical trials: An analysis of the initial approval documents in the Food and Drug Administration database.
| S-EPMC6422639 | biostudies-literature
Unknown Communication of Survival Data in US Food and Drug Administration-Approved Labeling of Cancer Drugs.
| S-EPMC8276121 | biostudies-literature
Unknown Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration.
| S-EPMC7296449 | biostudies-literature
Unknown Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.
| S-EPMC4804566 | biostudies-literature
Unknown Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.
| S-EPMC2586350 | biostudies-literature