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. 2020 Oct 14;10(10):e039969.
doi: 10.1136/bmjopen-2020-039969.

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

James Andrew Smith  1   2 , Roxanna E Abhari  3 , Zain Hussain  4 , Carl Heneghan  5 , Gary S Collins  3   6 , Andrew J Carr  3   2
Affiliations

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

James Andrew Smith et al. BMJ Open. .

Abstract

Objectives: 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).

Design: Cross-sectional study.

Setting: 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.

Main outcome measures: 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.

Results: 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.

Conclusions: 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.

Keywords: health policy; medical law; public health.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: JAS reports personal fees from Biolacuna, personal fees from IP Asset Ventures, outside the submitted work; and he is part of the Carr Group at the University of Oxford, which is developing medical devices. He receives funding from the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). CH reports that he has received expenses and fees for his media work and expenses from the WHO. He has received financial remuneration from an asbestos case. He receives expenses for teaching EBM and is also paid for his GP work in NHS out of hours. He is Director of the CEBM at the University of Oxford, Editor in Chief of BMJ Evidence-Based Medicine and an NIHR Senior Investigator. AJC reports grants from Novartis, outside the submitted work. In addition, AJC has a patent for Oxford Yarn issued, and a patent for Oxford Patch issued.

References

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