PMID- 30081071
OWN - NLM
STAT- MEDLINE
DCOM- 20190919
LR  - 20190919
IS  - 1878-5921 (Electronic)
IS  - 0895-4356 (Linking)
VI  - 104
DP  - 2018 Dec
TI  - Clinical trials on drug-drug interactions registered in ClinicalTrials.gov 
      reported incongruent safety data in published articles: an observational study.
PG  - 35-45
LID - S0895-4356(18)30213-0 [pii]
LID - 10.1016/j.jclinepi.2018.07.017 [doi]
AB  - OBJECTIVE: To assess safety data of trials on drug-drug interactions (DDIs) 
      reported in ClinicalTrials.gov and published in journal articles, since DDIs are 
      a growing concern. STUDY DESIGN AND SETTING: In an observational study of 
      clinical trials retrieved by the search term "drug-drug interaction(s)," we 
      collected the information on registration and on adverse events (AEs) from 
      ClinicalTrials.gov and corresponding publications. Trials were included if they 
      primarily investigated DDIs, had a National Clinical Trial identifier, and were 
      closed and completed by October 16, 2015. Publication data were extracted until 
      March 2017. RESULTS: Among 1,110 eligible trials, most were in phase 1 (76.8%), 
      industry-funded (68.8%), and started before registration (56.9%). Results were 
      not reported in the registry for 86.8% and not published for 68.1% trials. 
      Published AE data were completely identical to the data submitted to 
      ClinicalTrials.gov for only 15.6% trials. Among 64 trials with results reported 
      both in ClinicalTrials.gov and publications, 34.4% published concordant number 
      for other AEs. CONCLUSION: Discrepancies that emerge from incomplete or changed 
      reporting of AEs in publications emphasize the need to amend and enforce 
      regulatory requirements for timely and complete submission of results, clearer AE 
      reporting for trials focusing on DDIs, and regular assessment of the congruence 
      of AE data submitted to ClinicalTrials.gov and scientific journals during the 
      publication process.
CI  - Copyright (c) 2018 Elsevier Inc. All rights reserved.
FAU - Juric, Diana
AU  - Juric D
AD  - Department of Pharmacology, University of Split School of Medicine, Split, 
      Croatia. Electronic address: diana.juric@mefst.hr.
FAU - Pranic, Shelly
AU  - Pranic S
AD  - Department of Public Health, University of Split School of Medicine, Split, 
      Croatia; Department of Research in Biomedicine and Health, University of Split 
      School of Medicine, Split, Croatia.
FAU - Tokalic, Ruzica
AU  - Tokalic R
AD  - Department of Research in Biomedicine and Health, University of Split School of 
      Medicine, Split, Croatia.
FAU - Milat, Ana Marija
AU  - Milat AM
AD  - Department of Pharmacology, University of Split School of Medicine, Split, 
      Croatia.
FAU - Mudnic, Ivana
AU  - Mudnic I
AD  - Department of Pharmacology, University of Split School of Medicine, Split, 
      Croatia.
FAU - Pavlicevic, Ivancica
AU  - Pavlicevic I
AD  - Department of Family Medicine, University of Split School of Medicine, Split, 
      Croatia.
FAU - Marusic, Ana
AU  - Marusic A
AD  - Department of Research in Biomedicine and Health, University of Split School of 
      Medicine, Split, Croatia.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20180803
PL  - United States
TA  - J Clin Epidemiol
JT  - Journal of clinical epidemiology
JID - 8801383
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Clinical Trials as Topic
MH  - *Drug Interactions
MH  - Humans
MH  - *Publications
MH  - Registries
MH  - Research Design
OTO - NOTNLM
OT  - Adverse events
OT  - Bias
OT  - Clinical trials on drug-drug interaction as topic
OT  - Databases
OT  - Drug interaction
OT  - Reporting
EDAT- 2018/08/07 06:00
MHDA- 2019/09/20 06:00
CRDT- 2018/08/07 06:00
PHST- 2018/03/12 00:00 [received]
PHST- 2018/07/26 00:00 [revised]
PHST- 2018/07/31 00:00 [accepted]
PHST- 2018/08/07 06:00 [pubmed]
PHST- 2019/09/20 06:00 [medline]
PHST- 2018/08/07 06:00 [entrez]
AID - S0895-4356(18)30213-0 [pii]
AID - 10.1016/j.jclinepi.2018.07.017 [doi]
PST - ppublish
SO  - J Clin Epidemiol. 2018 Dec;104:35-45. doi: 10.1016/j.jclinepi.2018.07.017. Epub 
      2018 Aug 3.