Study: Many Digital Health Startups Lack Clinical Trials, Regulatory Filing

Many enterprise-supported digital health startups are not clinically robust, as measured by the number of regulatory filings and clinical trials, Published in the study JMIR.

The analysis examined digital health organizations using the Rock Health Digital Health Venture Funding Database, 510 (k), De Novo and Premarket Approval Filing, and the number and type of clinical trials listed on ClinicalTrials.gov. The researchers then assigned a “clinical firmness” score for each company, weighing the number of regulatory filings and clinical trials equally.

Of the 224 startups included in the study, 98 had a clinical firmness score of 0, with 45 receiving five or more. The average score was 2.5, including 1.8 clinical trials and 0.8 regulatory filings, and the median score was a.

The companies with the highest average scores were 2.8, followed by medical-centric companies with a score of 2.2 and finally prevention startups with a score of 1.9.

Startups that sell their products to employers have an average clinical firmness score of 3.1, with 2.7 for providers, 2.2 for consumers, and 2.0 for providers.

Researchers have also examined public claims made by companies or qualitative statements about clinical, economic and engagement outcomes. The average number of claims of the company was 1.3, where 43% of the companies made zero claims. The study further noted that startups sold to employers demanded more clinical, economic, and engagement than companies sold to other customer types, such as consumers, payers, and payers.

Overall, the study found no relationship between clinical perseverance and number of claims, persistence and total funding, or clinical perseverance and startup age.

The authors of the study wrote, “Despite hundreds of digital health organizations noticing the myriad needs across the continuity of care, clinical perseverance and public relations of demand are in many cases low,” the study authors wrote. “These results provide a significant opportunity for companies to differentiate themselves and demand greater legitimacy for customers for the products and services they purchase.”

Why it matters

The study authors, some of whom are members of the Rock Health research team, noted a number of limitations to the analysis, such as the possibility of missing a filing or clinical trial, and the decision to include Only Entrepreneur-backed companies that have raised more than $ 2 million

They suggest that future studies may use condition-specific metrics for effectiveness that may be standardized in clinical areas to provide a clear picture of the effect.

Although the analysis found that many startups lack clinical perseverance, it found that 20% of startups received a score of five or higher, offering a core of highly tested products. Nevertheless, the number of companies with low scores has shown that many enterprise-supported startups lack clinical evidence.

“While this sub-population may indicate progress, the lack of meaningful clinical validity for almost half of digital health companies (44% had a clinical strength score of 0) highlights a large gap in healthcare technology today,” the researchers wrote.

“The lack of an overall relationship between the company’s total enterprise funding and its clinical soundness score similarly highlights a significant discrepancy in how companies are potentially valued in today’s market (i.e., no relationship between clinical impact and funding). Reflects future expectations. “

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