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Pregled bibliografske jedinice broj: 1002177

Clinical trials on drug-drug interactions registered in ClinicalTrials.gov reported incongruent safety data in published articles: an observational study


Jurić, Diana; Pranić, Shelly; Tokalić, Ružica; Milat, Ana Marija; Mudnić, Ivana; Pavličević, Ivančica; Marušić, Ana
Clinical trials on drug-drug interactions registered in ClinicalTrials.gov reported incongruent safety data in published articles: an observational study // Journal of clinical epidemiology, 104 (2018), 35-45 doi:10.1016/j.jclinepi.2018.07.017 (međunarodna recenzija, članak, znanstveni)


CROSBI ID: 1002177 Za ispravke kontaktirajte CROSBI podršku putem web obrasca

Naslov
Clinical trials on drug-drug interactions registered in ClinicalTrials.gov reported incongruent safety data in published articles: an observational study

Autori
Jurić, Diana ; Pranić, Shelly ; Tokalić, Ružica ; Milat, Ana Marija ; Mudnić, Ivana ; Pavličević, Ivančica ; Marušić, Ana

Izvornik
Journal of clinical epidemiology (0895-4356) 104 (2018); 35-45

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
Clinical trials on drug-drug interaction as topic ; Drug interaction ; Databases ; Reporting ; Adverse events ; Bias

Sažetak
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.

Izvorni jezik
Engleski



POVEZANOST RADA


Citiraj ovu publikaciju

Jurić, Diana; Pranić, Shelly; Tokalić, Ružica; Milat, Ana Marija; Mudnić, Ivana; Pavličević, Ivančica; Marušić, Ana
Clinical trials on drug-drug interactions registered in ClinicalTrials.gov reported incongruent safety data in published articles: an observational study // Journal of clinical epidemiology, 104 (2018), 35-45 doi:10.1016/j.jclinepi.2018.07.017 (međunarodna recenzija, članak, znanstveni)
Jurić, D., Pranić, S., Tokalić, R., Milat, A., Mudnić, I., Pavličević, I. & Marušić, A. (2018) Clinical trials on drug-drug interactions registered in ClinicalTrials.gov reported incongruent safety data in published articles: an observational study. Journal of clinical epidemiology, 104, 35-45 doi:10.1016/j.jclinepi.2018.07.017.
@article{article, year = {2018}, pages = {35-45}, DOI = {10.1016/j.jclinepi.2018.07.017}, keywords = {Clinical trials on drug-drug interaction as topic, Drug interaction, Databases, Reporting, Adverse events, Bias}, journal = {Journal of clinical epidemiology}, doi = {10.1016/j.jclinepi.2018.07.017}, volume = {104}, issn = {0895-4356}, title = {Clinical trials on drug-drug interactions registered in ClinicalTrials.gov reported incongruent safety data in published articles: an observational study}, keyword = {Clinical trials on drug-drug interaction as topic, Drug interaction, Databases, Reporting, Adverse events, Bias} }
@article{article, year = {2018}, pages = {35-45}, DOI = {10.1016/j.jclinepi.2018.07.017}, keywords = {Clinical trials on drug-drug interaction as topic, Drug interaction, Databases, Reporting, Adverse events, Bias}, journal = {Journal of clinical epidemiology}, doi = {10.1016/j.jclinepi.2018.07.017}, volume = {104}, issn = {0895-4356}, title = {Clinical trials on drug-drug interactions registered in ClinicalTrials.gov reported incongruent safety data in published articles: an observational study}, keyword = {Clinical trials on drug-drug interaction as topic, Drug interaction, Databases, Reporting, Adverse events, Bias} }

Časopis indeksira:


  • Current Contents Connect (CCC)
  • Web of Science Core Collection (WoSCC)
    • Science Citation Index Expanded (SCI-EXP)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE


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