Research: Many digital health startups lack clinical trials, regulatory records

According to a Research published in JMIR.

The analysis examined digital health companies using the Rock Health Digital Health Grants Database, FDA data on 510(k), De Novo, and pre-market approval records. schools, the number and type of clinical trials listed on The researchers then assigned a “clinical endurance” score to each company, the total number of regulatory filings, and the weighted clinical trials.

Of the 224 startups included in the study, 98 had a clinical robustness score of 0, while 45 received a score of five or higher. The mean score was 2.5, with 1.8 clinical trials and 0.8 regulatory records, and the mean score was one.

Companies aimed at diagnosing the condition had the highest average score of 2.8, followed by treatment-focused companies of 2.2, and finally prevention startups, with score is 1.9.

Startups selling their products to employers received an average clinical durability score of 3.1, compared with 2.7 for vendors, 2.2 for consumers. and 2.0 for the payer.

The researchers also examined the companies’ public statements, or qualitative claims about clinical, economic, and commitment outcomes. The average number of claims by companies was 1.3, with 43% of companies not claiming. The study also notes that startups that sell to employers make more clinical, economic, and engagement claims than companies that sell to other types of customers, like consumers, suppliers and payers.

Overall, the study did not find any correlation between clinical solidity and the number of claims, robustness and total funding, or clinical solidity and start-up age.

The study’s authors write: “Despite hundreds of digital health companies targeting a multitude of needs across the entire care process, the clinical effectiveness and public communication of claims are warranted. remains low in most areas.” “These results represent a significant opportunity for companies to differentiate, and customers demand better validation of the products and services they purchase.”


The study’s authors, some of whom were members of the Rock Health research team, noted some limitations to the analysis, such as the potential for omitting clinical trials or records, and deciding intended to include only Venture-backed companies have raised more than $2 million.

They suggest that future studies could use condition-specific measures of effectiveness that could be standardized across clinical domains to provide a clearer picture of impact.

While the analysis showed many startups lacked clinical solidity, it found that 20% of startups received a score of five or more, showing the core of tried-and-tested products. high experience. However, the low number of companies with low scores demonstrates that many venture capital-backed startups lack clinical evidence.

“Although this subpopulation may herald progress, the lack of clinical validation is significant for nearly half of digital health companies (44% have a high score),” the researchers wrote. clinical durability of 0) highlights a major flaw in today’s healthcare technology”.

“The lack of an overall correlation between a company’s total venture capital investment and its clinically solid score also highlights a significant disparity in how potentially companies are appreciated in today’s market (i.e. no correlation between clinical impact and source of funds) However, it is possible that funding amounts reflect predicted future value rather than present value in. “

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