Abstract 10902: Association Between Funding Sources and the Scope and Outcomes of Cardiovascular Clinical Trials: A Systematic Review
Introduction: Limited data are available exploring trends and influence of funding sources on cardiovascular clinical trials scope and outcomes.
Methods: We abstracted data from all phase II to IV cardiovascular clinical trials from 2001 to 2012 published in the 8 highest Web of Science impact factor journals using both a PubMed database and manual journal search.
Results: Of the 1,224 trials evaluated, 581 (47.5%) were funded by industry, 273 (22.3%) by universities or other non-profit organizations, 159 (13%) by governments, 127 (10.4%) were jointly funded, and 84 (6.9%) did not report funding source. Proportion of industry and government funded trials trended down, while the proportion of non-profit and jointly-funded trials increased over time (P<0.001; Figure). Non-profit trials had the highest enrollment rates (P<0.001), while industry trials (44.1%) more commonly evaluated new therapies vs. placebo compared with other funding sources (P<0.001; Table). Positive outcomes were more likely to be reported by industry (65.6%) and non-profit (66.3%) trials compared to government (50.3%) or jointly-funded (45.7%) trials (P<0.001). After accounting for major trial characteristics, industry-funded (OR 2.37; 95% CI 1.61-3.49) and non-profit (OR 1.91; 95% CI 1.24-2.94) studies were more likely to report favorable outcomes compared with government-sponsored trials.
Conclusions: Funding sources of cardiovascular clinical trials are associated with various aspects of trial conduct and outcomes. Further research is required to explore the systematic influence of funding mechanisms on contemporary cardiovascular clinical trials.
Author Disclosures: M. Vaduganathan: None. A. Samman-Tahhan: None. L. Papadimitriou: None. V.V. Georgiopoulou: None. S.J. Greene: None. A.P. Kalogeropoulos: None. E. Peterson: Research Grant; Significant; Eli Lilly & Company, Janssen Pharmaceuticals, Inc.. Consultant/Advisory Board; Modest; Boehringer Ingelheim, Bristol-Myers Squibb, Janssen Pharmaceuticals, Inc., Pfizer, Genentech Inc. G.C. Fonarow: Consultant/Advisory Board; Modest; Medtronic, Amgen, Johnson & Johnson, Bayer, Boston Scientific. Research Grant; Significant; NIH. Consultant/Advisory Board; Significant; Novartis. M. Gheorghiade: Other; Modest; Abbott, Astellas, AstraZeneca, Bayer, Cardiorentis, CorThera, Cytokinetics, CytoPherx, DebioPharm, Errekappa Terapeutici, GlaxoSmithKline, Ikaria, Intersection Medical, Johnson & Johnson, Medtronic, Merck, Novartis, Ono Pharma, Otsuka, Palatin Technologies, Pericor Therapeutics, Protein Design, Sanofi-Aventis, Sigma Tau, Solvay, Sticares InterACT, Takeda, Trevena. J. Butler: Research Grant; Modest; National Institutes of Health, European Union. Consultant/Advisory Board; Modest; Amgen, Bayer, BG Medicine, Celladon, Gambro, GE Healthcare, Harvest, Medtronic, Ono Pharma, Stemedica, Trevena.
- © 2015 by American Heart Association, Inc.