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Changes to registration elements and results in a cohort of Clinicaltrials.gov trials were not reflected in published articles (CROSBI ID 639784)

Prilog sa skupa u zborniku | sažetak izlaganja sa skupa | domaća recenzija

Pranic, Shelly ; Marusic, Ana Changes to registration elements and results in a cohort of Clinicaltrials.gov trials were not reflected in published articles. 2016

Podaci o odgovornosti

Pranic, Shelly ; Marusic, Ana

engleski

Changes to registration elements and results in a cohort of Clinicaltrials.gov trials were not reflected in published articles

Objective: 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 clinical trials (RCT) 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. Methods: We extracted WHO Minimum Data Set items and study characteristics from ClinicalTrials.gov from the initial to last registration and from corresponding publications. We assessed discrepancies between the two data sources. Data were abstracted by one and verified by another author. Results: Among 81 eligible trials, most were industry-funded, with a drug intervention in parallel assignment. Secondary outcomes at 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 that were absent for 23.8% and 4.8% of RCTs, respectively, were published as non-occurring. 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 adverse events. This seriously undermines transparency surrounding clinical trials and their results. Stakeholders, administrators, and regulatory officials in health research need to focus on improving data reporting from clinical trials.

randomized controlled trials as topic; databases factual; drug side effects

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Podaci o prilogu

2016.

objavljeno

Podaci o matičnoj publikaciji

Podaci o skupu

The Eighth Croatian Cochrane Symposium

poster

09.05.2016-09.05.2016

Split, Hrvatska

Povezanost rada

Temeljne medicinske znanosti, Javno zdravstvo i zdravstvena zaštita