PMID- 26226103
OWN - NLM
STAT- MEDLINE
DCOM- 20160609
LR  - 20160129
IS  - 1878-5921 (Electronic)
IS  - 0895-4356 (Linking)
VI  - 70
DP  - 2016 Feb
TI  - Changes to registration elements and results in a cohort of Clinicaltrials.gov 
      trials were not reflected in published articles.
PG  - 26-37
LID - S0895-4356(15)00365-0 [pii]
LID - 10.1016/j.jclinepi.2015.07.007 [doi]
AB  - OBJECTIVES: To assess effectiveness of legislative initiatives to stimulate 
      public registration of trial results, we assessed adherence to protocol and 
      results reporting, changes to registry, and publication data for randomized 
      controlled trials (RCTs) after introduction of Food and Drug Administration 
      Amendment Act (FDAAA). STUDY DESIGN AND SETTING: Observational study of a cohort 
      of ClinicalTrials.gov registered FDAAA-covered RCTs found through 
      ClinicalTrials.gov between 2009 and 2012 and data from corresponding 
      publications. WHO Minimum Data Set items were abstracted by one author and 
      verified by the other author. RESULTS: Among 81 eligible trials, most were 
      industry-funded, with a drug intervention in parallel assignment. Secondary 
      outcomes at the initial and last registration were omitted for 17% and 19.7% of 
      RCTs, respectively. RCT registration changes mostly involved scientific title 
      (18.8%). Inclusion criteria omission was most common (88%) in publications. 
      Inferential statistical methods for primary and secondary outcomes matched 
      between registry and publication for 53.4% and 28.6% of RCTs, respectively. 
      Serious and other adverse events (AEs) that were absent for 23.8% and 4.8% of 
      RCTs, respectively, were published as nonoccurring. CONCLUSION: Discrepancies 
      remain relatively high between registered and published outcomes, particularly 
      regarding registered omissions in publications and concomitant reporting, nature 
      of statistical method used, and reporting of AEs. This seriously undermines 
      transparency of clinical trials and needs immediate attention of all stakeholders 
      in health research.
CI  - Copyright (c) 2016 Elsevier Inc. All rights reserved.
FAU - Pranic, Shelly
AU  - Pranic S
AD  - Department of Research in Biomedicine and Health, University of Split School of 
      Medicine, Soltanska 2, Split 21000, Croatia; Department of Public Health, 
      University of Split School of Medicine, Soltanska 2, Split 21000, Croatia. 
      Electronic address: shelly.pranic@mefst.hr.
FAU - Marusic, Ana
AU  - Marusic A
AD  - Department of Research in Biomedicine and Health, University of Split School of 
      Medicine, Soltanska 2, Split 21000, Croatia.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20150729
PL  - United States
TA  - J Clin Epidemiol
JT  - Journal of clinical epidemiology
JID - 8801383
SB  - IM
MH  - Drug Evaluation
MH  - Editorial Policies
MH  - Financing, Government
MH  - Guideline Adherence
MH  - Humans
MH  - Information Dissemination/*methods
MH  - Internet
MH  - *Periodicals as Topic
MH  - Publication Bias
MH  - Publishing/*standards/statistics & numerical data
MH  - Randomized Controlled Trials as Topic/*standards
MH  - Registries/*standards/statistics & numerical data
MH  - Research Report/*standards
MH  - Research Support as Topic
MH  - United States
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - Bias (epidemiology)
OT  - Databases
OT  - Drug side effects
OT  - Factual
OT  - Randomized controlled trials as topic
OT  - Reporting
EDAT- 2015/08/01 06:00
MHDA- 2016/06/10 06:00
CRDT- 2015/07/31 06:00
PHST- 2015/03/21 00:00 [received]
PHST- 2015/07/06 00:00 [revised]
PHST- 2015/07/20 00:00 [accepted]
PHST- 2015/07/31 06:00 [entrez]
PHST- 2015/08/01 06:00 [pubmed]
PHST- 2016/06/10 06:00 [medline]
AID - S0895-4356(15)00365-0 [pii]
AID - 10.1016/j.jclinepi.2015.07.007 [doi]
PST - ppublish
SO  - J Clin Epidemiol. 2016 Feb;70:26-37. doi: 10.1016/j.jclinepi.2015.07.007. Epub 
      2015 Jul 29.