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演讲者、小组成员和主持人在血液学和肿瘤学 FDA 研讨会上的财务利益冲突。

Financial conflicts of interest among presenters, panellists and moderators at haematology and oncology FDA workshops.

机构信息

Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.

出版信息

Eur J Clin Invest. 2024 Jun;54(6):e14184. doi: 10.1111/eci.14184. Epub 2024 Feb 26.

Abstract

OBJECTIVE

To assess the characteristics and financial conflicts of interest of presenters, panellists and moderators at haematology and oncology workshops held jointly with or hosted by the US FDA.

SETTING

We included information on all publicly available haematology or oncology FDA workshop agendas held between 1 January 2018 and 31 December 2022.

EXPOSURE

General and research payments reported on Open Payments, industry funding to patient advocacy organizations reported on their webpages or 990 tax forms and employment in both pharmaceutical and regulatory settings.

RESULTS

Among physicians eligible for payments, 78% received at least one payment from the industry between 2017 and 2021. The mean general payment amount was $82,170 for all years ($16,434 per year) and the median was $14,906 for all years ($2981 per year). Sixty-nine per cent of patient advocacy speakers were representing organizations that received financial support from the pharmaceutical industry. Among those representing regulatory agencies or pharmaceutical companies, 16% had worked in both settings during their careers.

CONCLUSIONS AND RELEVANCE

Our findings in this cross-sectional study show a majority of US-based physician presenters at haematology and oncology workshops held jointly with members of the US FDA have some financial conflict of interest with the pharmaceutical industry. These findings support the need for clear disclosures and suggest that a more balanced selection of presenters with fewer conflicts may help to limit bias in discussions between multiple stakeholders.

摘要

目的

评估在美国食品和药物管理局(FDA)联合举办或主办的血液学和肿瘤学研讨会上演讲者、小组成员和主持人的特征和财务利益冲突。

背景

我们纳入了 2018 年 1 月 1 日至 2022 年 12 月 31 日期间所有公开的血液学或肿瘤学 FDA 研讨会议程信息。

暴露情况

公开支付报告的一般和研究付款、网页或 990 税务表格报告的行业对患者倡导组织的资助以及制药和监管领域的就业情况。

结果

在有资格获得报酬的医生中,78%在 2017 年至 2021 年期间至少从行业获得了一次报酬。所有年份的一般支付金额平均为 82170 美元(每年 16434 美元),中位数为所有年份的 14906 美元(每年 2981 美元)。69%的患者倡导演讲者代表的组织从制药行业获得了财政支持。在代表监管机构或制药公司的人中,16%的人在职业生涯中同时在这两个领域工作过。

结论和相关性

在这项横断面研究中,我们发现大多数在美国举行的血液学和肿瘤学研讨会的演讲者与美国 FDA 成员一起,与制药行业存在一定程度的财务利益冲突。这些发现支持明确披露的必要性,并表明选择具有较少冲突的平衡代表性讲者可能有助于限制多方利益相关者之间讨论的偏见。

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