clinical trials, financial conflicts of interest, oncology, CMS Open Payments
Purpose: Because financial conflicts of interest (FCOIs) may potentially influence patient care, hospital drug formularies, and treatment guidelines, it is important that these are disclosed. The purpose of this observational study was to quantify the changes in FCOI among U.S.-based academic authors in industry-sponsored oncology trials after a high-impact publication.
Methods: A list of all U.S.-based academic authors (authors) of industry-sponsored solid tumor clinical trials published between August 1, 2014, and December 31, 2015, in 6 high-impact journals (New England Journal of Medicine, Nature, Science, Lancet Oncology, Journal of Clinical Oncology, and Cancer Discovery) was assembled. Studies were limited to solid tumor oncology trials. After all authors were identified, direct and research funding was tabulated from CMS Open Payments for the year prior (Ypre) and the first 3 years following publication (Y1, Y2, Y3) in the high-impact journal. Summary statistics were tabulated and repeated-measures linear mixed-effects regression models were fit to examine changes after publication.
Results: A total of 102 publications with a total of 620 authors were identified. No FCOI was declared by 11, 12, 21, and 24 authors in Ypre, Y1, Y2, and Y3, respectively. In Ypre, Y1, Y2, and Y3: median FCOI for direct payments was $16,702 (range: $0–$3,180,356), $20,830 (range: $0–$3,180,356), $22,031 (range: $0–$920,746), and $21,356 (range: $0–$920,707), respectively; while median research funding was $559,202 (range: $0–$19,973,818), $505,031 (range $0–$19,920,452), $502,726 (range: $0–$15,729,776), and $497,342 (range: $0–$43,036,716), respectively. There were nonsignificant increases in total direct payments and total direct payments received from the sponsor (P > 0.0125 for both) and statistically significant decreases in total associated research funding and total research funding from the research sponsor in Y1, Y2, and Y3 as compared to Ypre (P < 0.0001 for both).
Conclusions: After publication of an industry-sponsored solid tumor clinical trial in a high-impact journal, authors had statistically significant decreases in research funding FCOI in the first 3 years postpublication compared to the year prior.
Cambridge CL, Gatof ES, Weiss GJ, Davis RB. Financial conflicts of interest change after a high-impact clinical trial publication in oncology. J Patient Cent Res Rev. 2020;7:249-54. doi: 10.17294/2330-0698.1735
October 30th, 2019
January 15th, 2020