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THE IMPACT OF CONFLICTS OF INTEREST ON ADJUDICATION AND OUTCOMES IN CARDIOVASCULAR CLINICAL TRIALS
A132.E1237 JACC March 9, 2010 Volume 55, issue 10A
QUALITY OF CARE AND OUTCOMES ASSESSMENT THE IMPACT OF CONFLICTS OF INTEREST ON ADJUDICATION AND OUTCOMES IN CARDIOVASCULAR CLINICAL TRIALS ACC Poster Contributions Georgia World Congress Center, Hall B5 Sunday, March 14, 2010, 9:30 a.m.-10:30 a.m.
Session Title: Outcomes Research: Appropriateness and Clinical Trials Reporting Abstract Category: Appropriateness, Pay for Performance, Cost of Care Presentation Number: 1031-181 Authors: Ricardo Esquitin, Ashish Aneja, Kshitij A. Shah, Louai Razzouk, Devin M. Mann, Joseph S. Ross, Rupa Iyengar, Irfan U. Wali, Verghese Mathew, Michael E. Farkouh, Mount Sinai School of Medicine, New York, NY, MetroHealth Medical Center Campus of Case Western Reserve University, Cleveland, OH Background: The influence of investigators’ conflicts of interest on the outcomes of cardiovascular trials has become relevant to the current debate on escalating healthcare costs in the US. Evaluating the implications of competing financial interests on high impact cardiovascular publications has not been well documented. Methods: We conducted a systematic pubmed search for original consecutive cardiovascular (CV) articles in the New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), and Lancet between January 2000 and April 2008 as part of the Clinical Trials Reporting Database (CTRD). Articles were analyzed for self-reported financial disclosures (speaker’s bureau, consulting, stock ownership, or employment by sponsor) and whether investigators were directly involved in event adjudication. Results were then compared with the likelihood of a statistically significant primary outcome. Results: Of the 567 CV publications reviewed, 540 reported a funding source. Of these, 273 were entirely industry funded, 53 NIH-sponsored, and 214 a combination of industry and non-profit organizations (non-NIH government, and clinical research networks). A significant financial disclosure was reported in 276 articles, of which 52% were speaker’s bureau, 62% were consultants, 26% owned stock, 36% were sponsor employed, and 10% had other forms of financial disclosures. Of those disclosing a financial conflict of interest, 59.6% (n=183) demonstrated a benefit of the investigational therapy, as compared to 57.5% of the publications without a financial conflict of interest (P =0.668). Of the 191 studies with event adjudication reported, 169 were independently adjudicated and 22 studies were not. A significant primary outcome was found in 58.6% of those independently adjudicated vs. 50% of those that were not (p=0.496). Conclusion: Financial conflicts of interest and lack of independent adjudication of clinical events involving the authors of cardiovascular trials were found not to impact the likelihood of a statistically significant finding in favor of the investigational therapy in pivotal clinical trials.
QUALITY OF CARE AND OUTCOMES ASSESSMENT THE IMPACT OF CONFLICTS OF INTEREST ON ADJUDICATION AND OUTCOMES IN CARDIOVASCULAR CLINICAL TRIALS ACC Poster Contributions Georgia World Congress Center, Hall B5 Sunday, March 14, 2010, 9:30 a.m.-10:30 a.m.
Session Title: Outcomes Research: Appropriateness and Clinical Trials Reporting Abstract Category: Appropriateness, Pay for Performance, Cost of Care Presentation Number: 1031-181 Authors: Ricardo Esquitin, Ashish Aneja, Kshitij A. Shah, Louai Razzouk, Devin M. Mann, Joseph S. Ross, Rupa Iyengar, Irfan U. Wali, Verghese Mathew, Michael E. Farkouh, Mount Sinai School of Medicine, New York, NY, MetroHealth Medical Center Campus of Case Western Reserve University, Cleveland, OH Background: The influence of investigators’ conflicts of interest on the outcomes of cardiovascular trials has become relevant to the current debate on escalating healthcare costs in the US. Evaluating the implications of competing financial interests on high impact cardiovascular publications has not been well documented. Methods: We conducted a systematic pubmed search for original consecutive cardiovascular (CV) articles in the New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), and Lancet between January 2000 and April 2008 as part of the Clinical Trials Reporting Database (CTRD). Articles were analyzed for self-reported financial disclosures (speaker’s bureau, consulting, stock ownership, or employment by sponsor) and whether investigators were directly involved in event adjudication. Results were then compared with the likelihood of a statistically significant primary outcome. Results: Of the 567 CV publications reviewed, 540 reported a funding source. Of these, 273 were entirely industry funded, 53 NIH-sponsored, and 214 a combination of industry and non-profit organizations (non-NIH government, and clinical research networks). A significant financial disclosure was reported in 276 articles, of which 52% were speaker’s bureau, 62% were consultants, 26% owned stock, 36% were sponsor employed, and 10% had other forms of financial disclosures. Of those disclosing a financial conflict of interest, 59.6% (n=183) demonstrated a benefit of the investigational therapy, as compared to 57.5% of the publications without a financial conflict of interest (P =0.668). Of the 191 studies with event adjudication reported, 169 were independently adjudicated and 22 studies were not. A significant primary outcome was found in 58.6% of those independently adjudicated vs. 50% of those that were not (p=0.496). Conclusion: Financial conflicts of interest and lack of independent adjudication of clinical events involving the authors of cardiovascular trials were found not to impact the likelihood of a statistically significant finding in favor of the investigational therapy in pivotal clinical trials.