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10.1136/bmjopen-2016-013482

http://scihub22266oqcxt.onion/10.1136/bmjopen-2016-013482
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suck abstract from ncbi


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pmid28619765
      BMJ+Open 2017 ; 7 (6 ): e013482
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  • Early termination of cardiovascular trials as a consequence of poor accrual: analysis of ClinicalTrials gov 2006-2015 #MMPMID28619765
  • Baldi I ; Lanera C ; Berchialla P ; Gregori D
  • BMJ Open 2017[Jun]; 7 (6 ): e013482 PMID28619765 show ga
  • OBJECTIVES: To present a snapshot of experimental cardiovascular research with a focus on geographical and temporal patterns of early termination due to poor accrual. SETTING: The Aggregate Analysis of ClinicalTrials.gov (AACT) database, reflecting ClinicalTrials.gov as of 27 March 2016. DESIGN: The AACT database was searched for all cardiovascular clinical trials that started from January 2006 up to December 2015. RESULTS: 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). CONCLUSIONS: 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.
  • |*Biomedical Research [MESH]
  • |*Cardiovascular Diseases [MESH]
  • |*Clinical Trials as Topic [MESH]
  • |*Global Health [MESH]
  • |Databases, Factual [MESH]
  • |Early Termination of Clinical Trials/*statistics & numerical data [MESH]
  • |Humans [MESH]
  • |International Cooperation [MESH]
  • |Research Design [MESH]


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