The Disparity of Clinical Evidence in Digital Health Companies

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The Disparity of Clinical Evidence in Digital Health Companies

Overview

A few days ago, the Journal of Medical Internet Research published a paper that discusses the clinical robustness of digital health startups. They found a staggeringly low level of clinical robustness.

Another analysis conducted by Rock Health and Johns Hopkins University assessed the activity of 224 companies to objectify their clinical rigor. Note that these companies have collectively raised $8.2 billion since 2011. The same thing was found; these companies have a low score of clinical robustness.

Even worse, half of these companies had no clinical trials or regulatory findings to their name.

In conclusion, researchers described the low score of clinical robustness as “a major gap in healthcare technology.”

They also noted that companies that adopt a more rigorous approach to clinical evidence can differentiate themselves from the competition.

The clinical robustness and validation of digital health companies

Last year, the funding for digital health companies peaked in the United States. This is despite the fact that several studies questioned the clinical robustness and validation of these companies.

In 2021 alone, digital health firms raised approximately $29 billion. This marks a $15 billion increase from 2020. It’s important to note that funding levels slightly dropped as of 2022. 

Researchers at Rock Health took a look at 224 companies with an average of 7.7 years. 

Here is a breakdown of what these companies do:

  • Around half offer therapeutic solutions
  • Another half offers diagnostic solutions
  • Around 25 companies offer preventive solutions

To assess their clinical robustness, researchers had two criteria. The first is how many market applications these companies made to the Food and Drug Administration (FDA). The second is the number of clinical trials they sponsored or collaborated on. The average clinical robustness score for all companies was 2.5.

On average, each company worked on 1.8 clinical trials. However, the reality is far from this figure. A small band of businesses was actually the one that boosted this number due to their high clinical scores.

Around 1/5 of the companies scored 5 or higher on the scale of clinical robustness. Another 6% of companies scored 10 or higher. Surprisingly, 44% of companies had no records of clinical trials or regulatory filings. These digital health firms scored 0 on the clinical robustness scale.

The second part of the study – Marketed claims

The second part of the study inspected the claims made by these companies. By claims, we are talking about quantitative statements about the outcomes of the products made by these companies on their websites. Once again, researchers found a low average number of claims of around 1.3. 

The breakdown of this number is almost equal between clinical, economic, and engagement claims.

When searching for any correlation between clinical claims and clinical robustness, there was none. In fact, 32 companies made at least one clinical claim, even though they have a clinical robustness score of 0.

What’s surprising, however, is the lack of correlation between total funding and clinical robustness. In other words, companies were receiving a huge amount of money despite lacking any clinical evidence to support their products.

The authors wrote that “the lack of overall correlation between a company’s total venture funding and its clinical robustness score similarly highlighted a significant asymmetry in how companies are potentially valued in today’s marketplace (i.e., no correlation between clinical impact and funding). However, it is possible that funding amounts reflect future anticipated value rather than current value.”

Takeaway message

The lack of clinical evidence created a major gap in digital health companies. This serves as a significant opportunity for startups willing to adopt a more rigorous clinical approach.

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