Of 125 public comments submitted to the FDA on how best to regulate AI software as a medical device, nearly two-thirds came from parties with financial ties to industry, according to a study running in BMJ Open.
What’s more, the vast majority of those weighing in—108 commenters, or 86% of the field—cited no published research.
Interestingly, submitters who had a financial interest in the outcome of the process were no more likely to post evidence-free remarks than those with no apparent vested interest.
Also noteworthy: The study was conducted in the U.K.
Lead author James Andrew Smith and colleagues at the University of Oxford arrived at the findings by analyzing all publicly available comments made on the FDA document, which was open for input from April 2 to August 8 of 2019.
The document’s title was “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device (SaMD)—Discussion Paper and Request for Feedback.”
Additional findings from the Oxford team:
- For 36 comments (29%), the presence or absence of financial ties could not be confirmed.
- The absence of a financial tie could be confirmed in only 10 comments (8%).
- Just 4% cited a systematic review or meta-analysis.
- No comments indicated that a systematic process was used to identify relevant literature.
Calling the prevalence of financial ties to industry among commenters “high,” Smith and colleagues comment in their discussion that 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.”
In a news release sent by Oxford, co-author Gary Collins, a professor of medical statistics, says the team was “concerned by the lack of scientific evidence used in comments, and the dominance of industry over academic commenters, despite AI/machine learning being a very active area of research. But we hope our findings will bring the FDA proposal to the attention of academics and encourage more of them to participate in the next round of feedback on the framework, and other regulatory frameworks, where academic input could be valuable.”
The study is available in full for free.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.