Baldi Ileana, Lanera Corrado, Berchialla Paola, Gregori Dario
Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padova, Italy.
Department of Clinical and Biological Sciences, University of Torino, Torino, Italy.
BMJ Open. 2017 Jun 15;7(6):e013482. doi: 10.1136/bmjopen-2016-013482.
To present a snapshot of experimental cardiovascular research with a focus on geographical and temporal patterns of early termination due to poor accrual.
The Aggregate Analysis of ClinicalTrials.gov (AACT) database, reflecting ClinicalTrials.gov as of 27 March 2016.
The AACT database was searched for all cardiovascular clinical trials that started from January 2006 up to December 2015.
Thirteen thousand and seven hundred twenty-nine cardiovascular trials were identified. Of these, 8900 (65%) were classified as closed studies. Globally, 11% of closed trials were terminated. This proportion varied from 9.6% to 14% for trials recruiting from Europe and Americas, respectively, with a slightly decreasing trend (p=0.02) over the study period. The most common reason for trials failing to complete was poor accrual (41%). Intercontinental trials exhibited lower figures of poor accrual as the reason for their early stopping, as compared with trials recruiting in a single continent (28% vs 44%, p=0.002).
Poor accrual significantly challenges the successful completion of cardiovascular clinical trials. Findings are suggestive of a positive effect of globalisation of cardiovascular clinical research on the achievement of enrolment goals within a reasonable time frame.
呈现实验性心血管研究的概况，重点关注因入组不佳导致提前终止的地理和时间模式。
ClinicalTrials.gov汇总分析（AACT）数据库，反映截至2016年3月27日的ClinicalTrials.gov情况。
在AACT数据库中搜索2006年1月至2015年12月启动的所有心血管临床试验。
共识别出13729项心血管试验。其中，8900项（65%）被归类为已结束研究。在全球范围内，11%的已结束试验被终止。从欧洲和美洲招募的试验中，这一比例分别为9.6%和14%，在研究期间呈略微下降趋势（p=0.02）。试验未能完成的最常见原因是入组不佳（41%）。与在单个大陆招募的试验相比，洲际试验因入组不佳而提前终止的比例较低（28%对44%，p=0.002）。
入组不佳对心血管临床试验的成功完成构成重大挑战。研究结果表明心血管临床研究全球化对在合理时间框架内实现入组目标具有积极作用。
