Naslov
Late-registered randomized controlled trials in anesthesiology did not completely report results and adverse events data in ClinicalTrials.gov: a cross-sectional study

Autori
Vuković, Igor ; Pranić, Shelly

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

ISBN
0-000-00000-0

Skup
7th World Conference on Research Integrity

Mjesto i datum
Cape Town, Južnoafrička Republika, 29.05.2022. - 01.06.2022

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
ClinicalTrials.gov ; Trial registration ; Anesthesiology ; Randomized Controlled Trial ; Results reporting ; Adverse events reporting

Sažetak
Objective: Clinical trials that fail to report results within one year according to mandates endanger data credibility. We aimed to investigate the consistency and timeliness of reporting of results and adverse events in anesthetic drug randomized controlled trials (RCTs) between ClinicalTrials.gov and corresponding publications. Method: We searched for RCTs on 25 anesthetic drugs in ClinicalTrials.gov between 2009 and 2017 and retrieved corresponding full-text publications. For primary outcomes, discrepant key data elements, results, adverse events and time from trial completion to publication were reported as frequencies. Chi-square test and binomial logistic regression assessed differences in discrepant reporting of trial characteristics. Results: We selected 39 RCTs. As many as 21 (53.8%) of them demonstrated some discrepancy in results reporting. Serious adverse events were consistently reported in 36 (92.3%) trials, while other adverse events were consistently reported in only 13 (33.3%). Trials in our study that failed to comply with registration regulations provided discrepant results data more frequently than ones that registered on time (85.7% vs 36%, p<0.001). These trials also reported adverse events less consistently (odds ratio (OR), confidence interval (CI) 7.42 1.07-51.32). Regarding the months elapsed from the primary completion date of trials and the date of acceptance of publications, we found significant differences ; non-industry trials published sooner than industry trials and phase III trials published later than phase II or IV ones (p<0.001). Conclusion: Our novel study identified anesthesiology trials that registered after the deadline with significantly higher rates of discrepancies in results and adverse events reporting. These results emphasize the necessary role of peer-reviewers, editors, and journal administrators to check the validity of trial data and overall integrity of its research methodology.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti, Javno zdravstvo i zdravstvena zaštita, Integrativna bioetika (prirodne, tehničke, biomedicina i zdravstvo, biotehničke, društvene, humanističke znanosti), Biotehnologija u biomedicini (prirodno područje, biomedicina i zdravstvo, biotehničko područje)

POVEZANOST RADA