Ivanov Alexander, Kaczkowska Beata A, Khan Saadat A, Ho Jean, Tavakol Morteza, Prasad Ashok, Bhumireddy Geetha, Beall Allan F, Klem Igor, Mehta Parag, Briggs William M, Sacchi Terrence J, Heitner John F
Department of Medicine, NewYork-Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States of America.
PLoS One. 2017 Jan 20;12(1):e0170056. doi: 10.1371/journal.pone.0170056. eCollection 2017.
Over the past three decades, industry sponsored research expanded in the United States. Financial incentives can lead to potential conflicts of interest (COI) resulting in underreporting of negative study results.
We hypothesized that over the three decades, there would be an increase in: a) reporting of conflict of interest and source of funding; b) percentage of randomized control trials c) number of patients per study and d) industry funding.
Original articles published in three calendar years (1988, 1998, and 2008) in The Lancet, New England Journal of Medicine and Journal of American Medical Association were collected.
Studies were reviewed and investigational design categorized as prospective and retrospective clinical trials. Prospective trials were categorized into randomized or non-randomized and single-center or multi-center trials. Retrospective trials were categorized as registries, meta-analyses and other studies, mostly comprising of case reports or series. Study outcomes were categorized as positive or negative depending on whether the pre-specified hypothesis was met. Financial disclosures were researched for financial relationships and profit status, and accordingly categorized as government, non-profit or industry sponsored. Studies were assessed for reporting COI.
1,671 original articles were included in this analysis. Total number of published studies decreased by 17% from 1988 to 2008. Over 20 year period, the proportion of prospective randomized trials increased from 22 to 46% (p < 0.0001); whereas the proportion of prospective non-randomized trials decreased from 59% to 27% (p < 0.001). There was an increase in the percentage of prospective randomized multi-center trials from 11% to 41% (p < 0.001). Conversely, there was a reduction in non-randomized single-center trials from 47% to 10% (p < 0.001). Proportion of government funded studies remained constant, whereas industry funded studies more than doubled (17% to 40%; p < 0.0001). The number of studies with negative results more than doubled (10% to 22%; p<0.0001). While lack of funding disclosure decreased from 35% to 7%, COI reporting increased from 2% to 84% (p < 0.0001).
Improved reporting of COI, clarity in financial sponsorship, increased publication of negative results in the setting of larger and better designed clinical trials represents a positive step forward in the scientific publications, despite the higher percentage of industry funded studies.
在过去三十年中，美国由行业资助的研究有所增加。经济激励可能导致潜在的利益冲突，从而造成负面研究结果报告不足。
我们假设，在这三十年中，以下方面会有所增加：a）利益冲突和资金来源的报告；b）随机对照试验的比例；c）每项研究的患者数量；d）行业资助。
收集了发表于《柳叶刀》《新英格兰医学杂志》和《美国医学会杂志》三个历年（1988年、1998年和2008年）的原创文章。
对研究进行审查，并将研究设计分类为前瞻性和回顾性临床试验。前瞻性试验分为随机或非随机以及单中心或多中心试验。回顾性试验分为登记研究、荟萃分析和其他研究，主要包括病例报告或病例系列。根据预先设定的假设是否得到满足，将研究结果分类为阳性或阴性。研究财务披露情况，以了解财务关系和盈利状况，并据此分类为政府、非营利或行业资助。评估研究中利益冲突的报告情况。
本分析纳入了1671篇原创文章。从1988年到2008年，发表研究的总数下降了17%。在20年期间，前瞻性随机试验的比例从22%增加到46%（p<0.0001）；而前瞻性非随机试验的比例从59%下降到27%（p<0.001）。前瞻性随机多中心试验的比例从11%增加到41%（p<0.001）。相反，非随机单中心试验从47%减少到10%（p<0.001）。政府资助研究的比例保持不变，而行业资助研究增加了一倍多（从17%增至40%；p<0.0001）。结果为阴性的研究数量增加了一倍多（从10%增至22%；p<0.0001）。虽然资金披露缺失的情况从35%降至7%，但利益冲突报告从2%增至84%（p<0.0001）。
尽管行业资助研究的比例较高，但在科学出版物中，利益冲突报告的改善、资金赞助的明确、在规模更大且设计更好的临床试验中负面结果的更多发表代表了向前迈出的积极一步。
