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Items: 1 to 20 of 144

1.

Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.

Rising K, Bacchetti P, Bero L.

PLoS Med. 2008 Nov 25;5(11):e217; discussion e217. doi: 10.1371/journal.pmed.0050217. Erratum in: PLoS Med. 2009 Jan;6(1). doi: 10.1371/journal.Pmed.1000017.

2.

Participation of women and sex analyses in late-phase clinical trials of new molecular entity drugs and biologics approved by the FDA in 2007-2009.

Poon R, Khanijow K, Umarjee S, Fadiran E, Yu M, Zhang L, Parekh A.

J Womens Health (Larchmt). 2013 Jul;22(7):604-16. doi: 10.1089/jwh.2012.3753. Epub 2013 Jun 14.

3.

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

Lee K, Bacchetti P, Sim I.

PLoS Med. 2008 Sep 23;5(9):e191. doi: 10.1371/journal.pmed.0050191.

4.

Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses.

Hart B, Lundh A, Bero L.

BMJ. 2012 Jan 3;344:d7202. doi: 10.1136/bmj.d7202.

PMID:
22214754
5.

Central site monitoring: results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection.

Lindblad AS, Manukyan Z, Purohit-Sheth T, Gensler G, Okwesili P, Meeker-O'Connell A, Ball L, Marler JR.

Clin Trials. 2014 Apr;11(2):205-17. doi: 10.1177/1740774513508028. Epub 2013 Dec 2.

PMID:
24296321
6.

Participation of women in clinical trials for new drugs approved by the food and drug administration in 2000-2002.

Yang Y, Carlin AS, Faustino PJ, Motta MI, Hamad ML, He R, Watanuki Y, Pinnow EE, Khan MA.

J Womens Health (Larchmt). 2009 Mar;18(3):303-10. doi: 10.1089/jwh.2008.0971.

PMID:
19243271
7.

Reporting Bias in Clinical Trials Investigating the Efficacy of Second-Generation Antidepressants in the Treatment of Anxiety Disorders: A Report of 2 Meta-analyses.

Roest AM, de Jonge P, Williams CD, de Vries YA, Schoevers RA, Turner EH.

JAMA Psychiatry. 2015 May;72(5):500-10. doi: 10.1001/jamapsychiatry.2015.15.

PMID:
25806940
8.

Association of trial registration with the results and conclusions of published trials of new oncology drugs.

Rasmussen N, Lee K, Bero L.

Trials. 2009 Dec 16;10:116. doi: 10.1186/1745-6215-10-116.

9.

Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.

Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE.

JAMA. 2014 Jan 22-29;311(4):378-84. doi: 10.1001/jama.2013.282542.

PMID:
24449316
10.
11.

A Review of Patient-Reported Outcome Labeling in the United States (2011-2015).

Gnanasakthy A, Mordin M, Evans E, Doward L, DeMuro C.

Value Health. 2017 Mar;20(3):420-429. doi: 10.1016/j.jval.2016.10.006. Epub 2016 Dec 2.

PMID:
28292487
12.

Demographics of clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA From 2010 to 2012.

Eshera N, Itana H, Zhang L, Soon G, Fadiran EO.

Am J Ther. 2015 Nov-Dec;22(6):435-55. doi: 10.1097/MJT.0000000000000177.

PMID:
25621972
13.

Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions.

Page MJ, McKenzie JE, Kirkham J, Dwan K, Kramer S, Green S, Forbes A.

Cochrane Database Syst Rev. 2014 Oct 1;(10):MR000035. doi: 10.1002/14651858.MR000035.pub2.

PMID:
25271098
14.
15.
16.

FDA advisory committees and the new drug approval process.

Kaitin KI, Melville A, Morris B.

J Clin Pharmacol. 1989 Oct;29(10):886-90.

PMID:
2592579
17.

Timing of pivotal clinical trial results reporting for newly approved medications varied by reporting source.

Withycombe B, Ovenell M, Meeker A, Ahmed SM, Hartung DM.

J Clin Epidemiol. 2016 Sep;77:78-83. doi: 10.1016/j.jclinepi.2016.04.007. Epub 2016 Apr 22.

PMID:
27108488
18.
19.

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

Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R.

N Engl J Med. 2008 Jan 17;358(3):252-60. doi: 10.1056/NEJMsa065779.

20.

Exploratory analyses of efficacy data from schizophrenia trials in support of new drug applications submitted to the US Food and Drug Administration.

Khin NA, Chen YF, Yang Y, Yang P, Laughren TP.

J Clin Psychiatry. 2012 Jun;73(6):856-64. doi: 10.4088/JCP.11r07539. Epub 2012 May 15. Review.

PMID:
22687813

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