Lack of clinical evidence “major gap” in digital health: a study

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Brief information about diving:

  • Most digital healthcare companies have a low level of “clinical stability” as measured by the number of their regulatory documents and clinical trials, according to paper published in the Journal of Medical Internet Research.
  • Researchers from Rock Health and Johns Hopkins University analyzed the activities of 224 companies, which together have raised $ 8.2 billion since 2011 to determine their clinical rigor. The average score on the stability scale was one, reflecting the fact that almost half of the companies did not have regulatory documents or clinical trials to their names.
  • Researchers presented the low results for clinical stability as evidence of a “major gap in health technology”, adding that there is a “significant opportunity” for companies that differentiate through a stricter approach.

Diving Insight:

Funding for US digital healthcare companies grew last year despite the findings of surveys little clinical validation and a lack of solid evidence that digital health solutions are effective, according to Rock Health, a seed fund that tracks space. Rock Health noted that digital health companies have raised more than $ 29 billion in 2021up from $ 15 billion in 2020 and $ 8 billion in 2019, although funding levels began to decline in early 2022.

To understand the clinical rigor of digital healthcare companies, the researchers looked at 224 companies in the Rock Health Business Database. The companies had an average age of 7.7 years. About half of the companies offered treatment, and a similar part had diagnostic solutions. A smaller group of 25 companies proposed prevention solutions.

Researchers have calculated the clinical stability of companies by summing up the market applications they have made to the FDA and the clinical trials they have sponsored or collaborated with. The mean score for clinical stability is 2.5. This figure was supported by 1.8 clinical trials on which companies worked on average, and withdrawn from a small group of businesses that performed well.

One-fifth of companies have a clinical stability score of five or higher. Six percent scored 10 or more. However, the largest group of companies, 44%, do not have regulatory documents or clinical trials. The presence of a large group of companies with a score of zero explains the fact that the average score was one.

Another part of the study looks at claims identified as unique quantitative statements about the results of products that companies make on their websites. Again, researchers found little activity. The average number of claims is 1.3, which reflects the almost equal division of clinical, economic and commitment claims.

The researchers found no link between clinical stability and the number of clinical claims. Thirty-two companies have made one or more clinical claims, even though they have zero clinical stability score. Similarly, the study did not establish a link between clinical stability and overall funding. This lack of link between funding and stability has attracted the attention of researchers.

“The lack of an overall correlation between the company’s overall risk financing and its assessment of clinical stability similarly underscores a significant asymmetry in the way companies are potentially assessed in today’s market (ie no correlation between clinical impact and funding). However, it is possible that the amounts of funding reflect the future expected value and not the current value, “the authors write.

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