Financial interests and evidence in public comments on the FDA framework for modifications to artificial intelligence/machine learning-based medical devices
By
James Andrew Smith,
Roxanna E Abhari,
Zain Hussain,
Carl Heneghan,
Gary Collins,
Andrew J Carr
Posted 14 Dec 2019
medRxiv DOI: 10.1101/2019.12.11.19013953
The US Food and Drug Administration (FDA) has proposed a regulatory framework for modifications to artificial intelligence/machine learning-based software as a medical device (SaMD). We analysed the 125 non-duplicate and non-spam public comments on the proposed framework and found that industry and other parties with a potential financial interest contributed a minimum of 63% of comments and that the absence of a conflict of interest could be confirmed in only 8%. Despite the FDAs stated commitment to using scientific evidence in the rule-making process, 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 whether a systematic process was used to identify relevant literature. We recommend that the FDA requires disclosure of conflicts of interest in comments in the future. As the framework continues to be modified, engagement from non-conflicted parties and better use of scientific evidence may help to ensure the development of a regulatory system that best promotes patient interests.
Download data
- Downloaded 528 times
- Download rankings, all-time:
- Site-wide: 97,960
- In health policy: 255
- Year to date:
- Site-wide: 185,171
- Since beginning of last month:
- Site-wide: 127,953
Altmetric data
Downloads over time
Distribution of downloads per paper, site-wide
PanLingua
News
- 27 Nov 2020: The website and API now include results pulled from medRxiv as well as bioRxiv.
- 18 Dec 2019: We're pleased to announce PanLingua, a new tool that enables you to search for machine-translated bioRxiv preprints using more than 100 different languages.
- 21 May 2019: PLOS Biology has published a community page about Rxivist.org and its design.
- 10 May 2019: The paper analyzing the Rxivist dataset has been published at eLife.
- 1 Mar 2019: We now have summary statistics about bioRxiv downloads and submissions.
- 8 Feb 2019: Data from Altmetric is now available on the Rxivist details page for every preprint. Look for the "donut" under the download metrics.
- 30 Jan 2019: preLights has featured the Rxivist preprint and written about our findings.
- 22 Jan 2019: Nature just published an article about Rxivist and our data.
- 13 Jan 2019: The Rxivist preprint is live!