BackgroundAll randomized-controlled trials (RCTs) are required to follow high methodological standards. In this study, we aimed to assess the methodological quality of published cardiovascular clinical research trials in a representative sample of RCTs published in 2017.MethodsCochrane Central Register of Controlled Trials was used to identify cardiovascular clinical research trials with adult participants published in 2017. Overall, 250 (10%) RCTs were randomly selected from a total of 2,419 studies. Data on general trial characteristics were extracted and the risk of bias (RoB) was determined.ResultsOverall, 86% of RCTs have reported at least one statistically significant result, with the primary outcome significant in 69%, treatment favored in 55%, and adverse events reported in 68%. Less than one-third (29%) of trials were overall low RoB, while the other two-thirds were rated unclear (40%) or with high RoB (31%). Sequence generation, allocation concealment, and selective reporting were the domains most often rated with high RoB. Drug trials were more likely to have low RoB than non-drug trials. Significant differences were found in RoB for the allocation concealment and blinding of participants and personnel between industry-funded and non-industry-funded trials, with industry-funded trials more often rated at low RoB.ConclusionAlmost two-thirds of RCTs in the field of cardiovascular disease (CVD) research, were at high or unclear RoB, indicating a need for more rigorous trial planning and conduct. Prospective trial registration is a factor predicting a lower risk of bias.
Objectives The aim of our current study was to analyze whether important measures of methodological quality and reporting of randomized controlled trials published in the field of cardiovascular disease research changed over time. Further aim was to investigate whether there was an improvement over time in the ability of these trials to provide a good estimate of the true intervention effect. Methods We conducted two separate searches in the Cochrane Central Register of Controlled Trials (CENTAL) database to identify cardiovascular clinical research trials published in either 2012 or 2017. Randomized controlled trials (RCTs) trials in cardiovascular disease research with adult participants were eligible to be included. We randomly selected 250 RCTs for both publication year 2012 and 2017. Trial characteristics, data on measures of methodological quality and reporting were extracted and risk of bias for each trial was assessed. Results As compared to 2012 in 2017 there were significant changes in important measures of methodological quality and reporting, including an improvement in the reporting of the presence of a data monitoring committee (42.0% vs. 34.4%), and a positive tendency of registering cardiovascular disease research RCTs in clinical trial registries (83.6% vs. 72.0%). On the other hand, we also observed that significantly fewer RCTs reported sample size calculation (60.4% vs. 98.4%) in 2017 as compared to 2012. RCTs in 2017 were more likely to have low overall RoB than in 2012 (29.2% vs. 21.2%). However, the 5-year-change was not clearly in the direction of improvement for all RoB domains. In 2017 multicenter trials, drug trials and registered trials were also more likely to have a low overall RoB, than single center, non-drug on non-registered trials. In 2012 specific trial characteristics had not yet a significant impact on overall RoB. Conclusion: As compared to 2012 in 2017 there were significant improvement in some, but not all the important measures of methodological quality. Although more trials in the field of cardiovascular disease research had a lower overall RoB in 2017, the improvement over time was not consistently perceived in all RoB domains.
Background Clinical research should provide reliable evidence to clinicians, health policy makers, and researchers. The reliability of evidence will be assured once study planning, conducting, and reporting of results are transparent. The present research investigates publication rates, time until publication, and characteristics of clinical trials on medicinal products associated with timely publication of results, measures of scientific impact, authorship, and open access publication. Methods Clinical trials authorized in Hungary in 2012 were followed until publication and/or June 2020. Corresponding scientific publications were searched via clinical trial registries, PubMed (MEDLINE), and Google. Results Overall, 330 clinical trials were authorized in 2012 of which 232 trials were completed for more than 1 year in June 2020. The proportion of industry initiation was high (97%). Time to publication was 21 (22) months [median (IQR)]. Time to publication was significantly shorter when trials involved both European and non-European countries (26 vs 69 months [median]; hazard ratio = 0.38, 95% CI 0.22–0.66, p< 0.001), and were registered in both EU CTR and clinicaltrials.gov (27 vs 88 months; hazard ratio = 0.24, 95% CI 0.11–0.54; p< 0.001) based on survival analyses. A significant amount (24.1%) of unpublished clinical trial results were accessible in a trial register. The majority of available publications were published “open access” (70.93%). A minority of identified publications had a Hungarian author (21.5%). Conclusions We encourage academic researchers to plan, register and conduct trials on medicinal products. Registries should be considered as an important source of information of clinical trial results. Publications with domestic co-authors contribute to the research output of a country. Measurable domestic scientific impact of trials on medicinal products needs further improvement.
Background: Clinical research should provide reliable evidence to clinicians, health policy makers and researchers, which is only possible once the results are made transparently available. The present research aims to investigate factors influencing publication rates, time and characteristics of clinical trials on medicinal products and to assess the degree of accessibility of trial results on a country level.Methods: Clinical trials authorized in Hungary in the year of 2012 were followed until publication and/or June 2020. Corresponding scientific publications were searched via clinical trial registries, Pubmed (MEDLINE) and Google.Results: Out of 330 clinical trials authorized in 2012, a total of 232 trials were completed for more than 1 year in June 2020. The proportion of industry-initiation was high (97%). Time to publication was 21 (22) months [median (IQR)]. Time to publication was significantly shorter when trials involved both European and non-European countries (p<0.001), and when registered in both EU CTR and clinicaltrials.gov (p<0.001) based on survival analyses. A significant amount (24.1%) of unpublished clinical trial results were accessible in a trial register. A total of 70.93% of available publications were published “open access”.Publications with domestic co-authors contribute to the research output of a country. In our study only 21.5% of the identified publications had a Hungarian author.Conclusions: We encourage academic researchers to plan, register and conduct trials on medicinal products. Registries should be considered as an important source of information of clinical trials results. Measurable domestic scientific impact of trials on medicinal products need further improvement.
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