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ClinicalTrials.gov and Drugs@FDA: A comparison of results reporting for new drug approval trials

BACKGROUND: Pharmaceutical companies and other trial sponsors must submit certain trial results to ClinicalTrials.gov. The validity of these results is unclear. PURPOSE: To validate results posted on ClinicalTrials.gov against publicly-available FDA reviews on Drugs@FDA. DATA SOURCES: ClinicalTrials...

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Bibliografski detalji
Izdano u:Ann Intern Med
Glavni autori: Schwartz, Lisa M., Woloshin, Steven, Zheng, Eugene, Tse, Tony, Zarin, Deborah A.
Format: Artigo
Jezik:Inglês
Izdano: 2016
Teme:
Online pristup:https://ncbi.nlm.nih.gov/pmc/articles/PMC5028264/
https://ncbi.nlm.nih.gov/pubmed/27294570
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.7326/M15-2658
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