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

Autori
Pranic, Shelly ; Marusic, Ana

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Skup
The Eighth Croatian Cochrane Symposium

Mjesto i datum
Split, Hrvatska, 09.05.2016

Vrsta sudjelovanja
Poster

Vrsta recenzije
Domaća recenzija

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

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Temeljne medicinske znanosti, Javno zdravstvo i zdravstvena zaštita

POVEZANOST RADA