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. 2014 Sep;174(9):1518-20.
doi: 10.1001/jamainternmed.2014.3438.

Publication of pivotal efficacy trials for novel therapeutic agents approved between 2005 and 2011: a cross-sectional study

James W Smithy  1 , Nicholas S Downing  1 , Joseph S Ross  2
Affiliations

Publication of pivotal efficacy trials for novel therapeutic agents approved between 2005 and 2011: a cross-sectional study

James W Smithy et al. JAMA Intern Med. 2014 Sep.
No abstract available

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Conflict of interest statement

Conflicts of interest: Mr. Smithy reports that he owns a small number of shares of the following pharmaceutical companies: small number of shares of Bristol Myers Squibb, Gilead, Johnson and Johnson, and Roche. Dr. Ross reports that he is a member of a scientific advisory board for FAIR Health, Inc.

References

    1. Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005–2012. JAMA. 2014;311(4):368–377. - PMC - PubMed
    1. Lee K, Bacchetti P, Sim I. Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis. PLoS Med. 2008;5(9):e191. - PMC - PubMed
    1. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252–260. - PubMed
    1. Ross JS, Gross CP, Krumholz HM. Promoting Transparency in Pharmaceutical Industry-Sponsored Research. Am J Public Health. 2012;102(1):72–80. - PMC - PubMed
    1. U.S. National Library of Medicine, U.S. National Institutes of Health, U.S. Department of Health and Human Services. ClinicalTrials.gov: Advanced Search. Available at: http://clinicaltrials.gov/ct2/search/advanced. Accessed October 30, 2013.

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