Industry ties and evidence in public comments on the FDA framework for modifications to artificial intelligence/machine learning-based medical devices: a cross sectional study.
Industry ties and evidence in public comments on the FDA framework for modifications to artificial intelligence/machine learning-based medical devices: a cross sectional study.
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行业联系和关于FDA人工智能/机器学习医疗设备修改框架的公开评论中的证据：一项横断面研究。
DOI：
10.1136/bmjopen-2020-039969
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发表时间：
2020-10-14
期刊：
影响因子：
2.9
通讯作者：
Carr AJ
中科院分区：
文献类型：
--
作者：
Smith JA;Abhari RE;Hussain Z;Heneghan C;Collins GS;Carr AJ
旨在确定与行业的财务关系的程度和披露，以及在对美国食品药品监督管理局（FDA）监管框架的评论中使用科学证据，以修改基于人工智能/机器学习（AI/ML）的软件作为医疗器械（SaMD）。横断面研究。我们检索了2019年4月2日至2019年8月8日期间关于FDA“修改基于人工智能/机器学习（AI/ML）的医疗器械软件（SaMD）的拟议监管框架-讨论文件和反馈请求”的所有公开评论。与行业有财务联系的各方提交的文章比例，披露这些联系，引用科学文章，引用系统性综述和荟萃分析，并使用系统性过程识别相关文献。我们分析了就拟议框架提交的125条意见。79条（63%）评论来自有财务联系的缔约方; 36条（29%）评论不清楚，只有10条（8%）评论可以确认没有财务联系。在任何非行业提交者的评论中，都没有披露任何财务关系。绝大多数提交的评论（86%）没有引用任何科学文献，只有4%引用了系统综述或荟萃分析，没有评论表明使用了系统过程来识别相关文献。与工业界的财务联系很常见，而且没有披露，科学证据，包括系统性审查和荟萃分析，很少被引用。为了确保监管框架最好地服务于患者利益，FDA应强制要求在评论中披露潜在的利益冲突（包括财务关系），鼓励使用科学证据，并鼓励非冲突方的参与。
To determine the extent and disclosure of financial ties to industry and use of scientific evidence in comments on a US Food and Drug Administration (FDA) regulatory framework for modifications to artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD). Cross-sectional study. We searched all publicly available comments on the FDA ‘Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)—Discussion Paper and Request for Feedback’ from 2 April 2019 to 8 August 2019. The proportion of articles submitted by parties with financial ties to industry, disclosing those ties, citing scientific articles, citing systematic reviews and meta-analyses, and using a systematic process to identify relevant literature. We analysed 125 comments submitted on the proposed framework. 79 (63%) comments came from parties with financial ties; for 36 (29%) comments, it was not clear and the absence of financial ties could only be confirmed for 10 (8%) comments. No financial ties were disclosed in any of the comments that were not from industry submitters. The vast majority of submitted comments (86%) did not cite any scientific literature, just 4% cited a systematic review or meta-analysis and no comments indicated that a systematic process was used to identify relevant literature. Financial ties to industry were common and undisclosed, and scientific evidence, including systematic reviews and meta-analyses, were rarely cited. To ensure regulatory frameworks best serve patient interests, the FDA should mandate disclosure of potential conflicts of interest (including financial ties) in comments, encourage the use of scientific evidence, and encourage engagement from non-conflicted parties.
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影响因子：
6.6
作者：
Pham-Kanter, Genevieve
通讯作者：
Pham-Kanter, Genevieve
影响因子：
3.3
作者：
Hayes, Michael J.;Prasad, Vinay
通讯作者：
Prasad, Vinay
影响因子：
3.7
作者：
Zargar, Nasim;Carr, Andrew
通讯作者：
Carr, Andrew
影响因子：
82.9
作者：
He, Jianxing;Baxter, Sally L.;Zhang, Kang
通讯作者：
Zhang, Kang
DOI：
10.1136/bmj.k4997
发表时间：
2018-11-25
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Lenzer, Jeanne
通讯作者：
Lenzer, Jeanne