临床医生在向加拿大泛癌症药物审查机构提交申请时的财务利益冲突：一项描述性研究。
Financial conflicts of interest of clinicians making submissions to the pan-Canadian Oncology Drug Review: a descriptive study.
机构信息
School of Health Policy & Management, York University, Toronto, Ontario, Canada.
出版信息
BMJ Open. 2019 Jul 26;9(7):e030750. doi: 10.1136/bmjopen-2019-030750.
OBJECTIVES
This study examines financial conflict of interest (FCOI) of clinicians who made submissions to the pan-Canadian Oncology Drug Review (pCODR), the arm of the Canadian Agency for Drugs and Technology in Health that recommends whether oncology drug indications should be publicly funded. Final reports from pCODR published between October 2016 and February 2019 were examined.
DESIGN
Descriptive study.
DATA SOURCES
Website of pCODR.
INTERVENTIONS
None.
PRIMARY AND SECONDARY OUTCOMES
The primary outcome is the number of submissions declaring FCOI. Secondary outcomes are the number of times where clinicians agreed and disagreed with preliminary recommendation from pCODR and the association between the distribution of individual clinicians' FCOI and pCODR's funding recommendations.
RESULTS
There were 46 drug indication reports from pCODR. Clinicians made 261 submissions. Clinicians declared they received payments from companies 323 times and named 38 different companies making those payments a total of 500 times. Financial conflicts with drug companies were declared in 176 (66.3%) of all submissions. In 21 (45.7%) of the 46 drug indications, 50% or more of the clinicians had a conflict with the company making the drug. Clinicians commented on 37 preliminary recommendations. In all 25 where pCODR recommended funding or conditional funding, the clinicians either agreed or agreed in part. pCODR recommended that the drug indication not be funded 12 times and 9 times clinicians disagreed with that recommendation. The distribution of clinician responses was statistically significantly different depending on whether pCODR recommended funding/conditional funding or do not fund p<0.0001 (Fisher exact test). The distribution of clinicians' FCOI differed depending on whether the recommendation was fund/conditional fund or do not fund p=0.027 (Fisher exact test).
CONCLUSION
Financial conflicts with pharmaceutical companies are widespread among experts making submissions to the pCODR.
目的
本研究考察了向加拿大药品和技术评估机构（CADTH）下属的加拿大肿瘤药物综合评价机构（pCODR）提交申请的临床医生的财务利益冲突（FCOI）情况，该机构负责建议是否对肿瘤药物适应证进行公共资助。研究分析了 2016 年 10 月至 2019 年 2 月期间公布的 pCODR 的最终报告。
设计
描述性研究。
资料来源
pCODR 网站。
干预措施
无。
主要和次要结局
主要结局是申报 FCOI 的申请数量。次要结局是临床医生同意和不同意 pCODR 初步建议的次数，以及个别临床医生 FCOI 的分布与 pCODR 资助建议之间的关系。
结果
pCODR 共有 46 个药物适应证报告，临床医生提交了 261 份申请。临床医生申报他们从公司获得了 323 次付款，共涉及 38 家不同的公司，总计 500 次。在所有 261 份申请中，有 176 份（66.3%）申报了与制药公司的财务冲突。在 46 种药物适应证中的 21 种（45.7%），有 50%或更多的临床医生与生产该药物的公司存在冲突。临床医生对 37 项初步建议发表了评论。在所有 25 项 pCODR 建议资助或有条件资助的情况下，临床医生要么完全同意，要么部分同意。pCODR 建议不资助适应证 12 次，临床医生 9 次不同意该建议。根据 pCODR 是否建议资助/有条件资助或不资助，临床医生的反应分布存在统计学显著差异（p<0.0001，Fisher 精确检验）。根据建议是资助/有条件资助还是不资助，临床医生的 FCOI 分布也存在统计学显著差异（p=0.027，Fisher 精确检验）。
结论
向 pCODR 提交申请的专家与制药公司存在广泛的财务利益冲突。
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