Dataset Information

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.

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.

SUBMITTER: Smith JA

PROVIDER: S-EPMC7559037 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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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.

Smith James Andrew JA Abhari Roxanna E RE Hussain Zain Z Heneghan Carl C Collins Gary S GS Carr Andrew J AJ

BMJ open 20201014 10

<h4>Objectives</h4>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).<h4>Design</h4>Cross-sectional study.<h4>Setting</h4>We searched all publicly available comments on the FDA 'Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine L ...[more]

PMID: 33055121

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Project description:ImportanceContemporary approaches to artificial intelligence (AI) based on deep learning have generated interest in the application of AI to breast cancer screening (BCS). The US Food and Drug Administration (FDA) has approved several next-generation AI products indicated for BCS in recent years; however, questions regarding their accuracy, appropriate use, and clinical utility remain.ObjectivesTo describe the current FDA regulatory process for AI products, summarize the evidence used to support FDA clearance and approval of AI products indicated for BCS, consider the advantages and limitations of current regulatory approaches, and suggest ways to improve the current system.Evidence reviewPremarket notifications and other publicly available documents used for FDA clearance and approval of AI products indicated for BCS from January 1, 2017, to December 31, 2021.FindingsNine AI products indicated for BCS for identification of suggestive lesions and mammogram triage were included. Most of the products had been cleared through the 510(k) pathway, and all clearances were based on previously collected retrospective data; 6 products used multicenter designs; 7 products used enriched data; and 4 lacked details on whether products were externally validated. Test performance measures, including sensitivity, specificity, and area under the curve, were the main outcomes reported. Most of the devices used tissue biopsy as the criterion standard for BCS accuracy evaluation. Other clinical outcome measures, including cancer stage at diagnosis and interval cancer detection, were not reported for any of the devices.Conclusions and relevanceThe findings of this review suggest important gaps in reporting of data sources, data set type, validation approach, and clinical utility assessment. As AI-assisted reading becomes more widespread in BCS and other radiologic examinations, strengthened FDA evidentiary regulatory standards, development of postmarketing surveillance, a focus on clinically meaningful outcomes, and stakeholder engagement will be critical for ensuring the safety and efficacy of these products.

Dataset Information

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.

Publications

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.

Similar Datasets

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