Literature DB >> 25070357

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

James W Smithy1, Nicholas S Downing1, Joseph S Ross2.   

Abstract

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Year:  2014        PMID： 25070357      PMCID： PMC4221247          DOI： 10.1001/jamainternmed.2014.3438

Source DB:  PubMed          Journal:  JAMA Intern Med        ISSN： 2168-6106            Impact factor:   21.873


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  4 in total

1.  Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.

Authors:  Nicholas S Downing; Jenerius A Aminawung; Nilay D Shah; Harlan M Krumholz; Joseph S Ross
Journal:  JAMA       Date:  2014 Jan 22-29       Impact factor: 56.272

2.  Promoting transparency in pharmaceutical industry-sponsored research.

Authors:  Joseph S Ross; Cary P Gross; Harlan M Krumholz
Journal:  Am J Public Health       Date:  2011-11-28       Impact factor: 9.308

3.  Selective publication of antidepressant trials and its influence on apparent efficacy.

Authors:  Erick H Turner; Annette M Matthews; Eftihia Linardatos; Robert A Tell; Robert Rosenthal
Journal:  N Engl J Med       Date:  2008-01-17       Impact factor: 91.245

4.  Publication of clinical trials supporting successful new drug applications: a literature analysis.

Authors:  Kirby Lee; Peter Bacchetti; Ida Sim
Journal:  PLoS Med       Date:  2008-09-23       Impact factor: 11.069
  4 in total
  8 in total

1.  Number of citations 1 year after publication of trial results and their relation to medicines regulatory approval.

Authors:  Rafael Dal-Ré
Journal:  Br J Clin Pharmacol       Date:  2016-01-14       Impact factor: 4.335

2.  Publication and Reporting of the Results of Postmarket Studies for Drugs Required by the US Food and Drug Administration, 2009 to 2013.

Authors:  Marisa L Cruz; Jing Xu; Mwango Kashoki; Peter Lurie
Journal:  JAMA Intern Med       Date:  2017-08-01       Impact factor: 21.873

3.  Review of clinical trial settings of drugs commonly used in primary care and approved between 2005 and 2012.

Authors:  Jason R Crossley; Tina P Tan; Keisha Herbin Smith; Joseph S Ross; Daniel J Merenstein
Journal:  J Gen Intern Med       Date:  2018-09       Impact factor: 5.128

4.  Time to publication of oncology trials and why some trials are never published.

Authors:  Paul B Chapman; Nathan J Liu; Qin Zhou; Alexia Iasonos; Sara Hanley; George J Bosl; David R Spriggs
Journal:  PLoS One       Date:  2017-09-21       Impact factor: 3.240

5.  Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study.

Authors:  Joshua D Wallach; Oriana Ciani; Alison M Pease; Gregg S Gonsalves; Harlan M Krumholz; Rod S Taylor; Joseph S Ross
Journal:  BMC Med       Date:  2018-03-21       Impact factor: 8.775

6.  Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis.

Authors:  Joshua D Wallach; Alexander C Egilman; Sanket S Dhruva; Margaret E McCarthy; Jennifer E Miller; Steven Woloshin; Lisa M Schwartz; Joseph S Ross
Journal:  BMJ       Date:  2018-05-24

Review 7.  Association of the FDA Amendment Act with trial registration, publication, and outcome reporting.

Authors:  Adam T Phillips; Nihar R Desai; Harlan M Krumholz; Constance X Zou; Jennifer E Miller; Joseph S Ross
Journal:  Trials       Date:  2017-07-18       Impact factor: 2.279

8.  Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study.

Authors:  Constance X Zou; Jessica E Becker; Adam T Phillips; James M Garritano; Harlan M Krumholz; Jennifer E Miller; Joseph S Ross
Journal:  Trials       Date:  2018-10-23       Impact factor: 2.279
  8 in total

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