Purpose: To perform an analysis of trends and characteristics of Sepsis studies registered in ClinicalTrials.gov (CTG).

Methods: The clinical studies related to sepsis registered on ClinicalTrials.gov (CTG) from September 27, 2007 to June 30, 2023, were identified using Advanced Search feature in ClinicalTrials.gov. The search terms also included bloodstream infections and toxemia. Trial characteristics were assessed by relative frequency calculations. Odds ratio and 95% confidence intervals were determined for the key characteristics.

Results: September 27, 2007 to June 30, 2023, a total of 3,88,228 studies were registered in CTG, Of these, around 0.68% (2,628 studies) were conducted for sepsis disease, There were 56.01% (1472 studies) interventional and 43.99% (1156) observational studies. While comparing the proportion of Interventional studies in sepsis to the overall studies registered in CTG it was found that the proportion of interventional studies in sepsis was lower (OR 0.39; 95 % CI: 0.3618 to 0.4224; P < 0.0001). On further assessment, the proportion of registry studies in sepsis was higher compared to overall studies registered in CTG (OR 1.73; 95 % CI: 0.3618 to 0.4224; P < 0.0001).

In sepsis, a total of 438 studies (16.67%) received funding from the industry, while 142 studies (5.4%) were funded by the National Institute of Health (NIH) and other U.S Federal agencies (FA). Majority of the studies, 78.86% (485) were funded by all others, including individuals, universities, research organizations etc. The proportion of sepsis studies funded by the industry and the NIH and other FA were lower in comparison with the all studies registered in CTG, with the industry funding 28.91% and the NIH funding 7.36%. Of all registered studies. Out of ongoing 615 studies in sepsis, 13.82% (85) studies are funded by the industry, 8.29% (51) were funded by the NIH and other U.S Federal agencies, and 78.86% (485) studies are funded by all others. Interestingly, there was slight decrease in the proportion of ongoing studies (indicator of recent studies) funded by the industry in comparison with all registered studies for sepsis (13.82 % vs 16.67 %), however, this difference was not statistically significant (OR 0.8; 95 % CI 0.6239 to 1.0306 and P = 0.0846), However, there was a significant increase in the funding rates by NIH and FA (OR 1.58; 95 % CI 1.1350 to 2.2081 and P < 0.0001). Overall rates of studies funded by others remained similar between the all the sepsis studies and the ongoing sepsis studies.

The proportion of early phase studies, phase 1 (OR 0.3627; 95 % CI: 0.3012 to 0.4367; P < 0.0001) and phase 2 (OR 0.6581; 95 % CI: 0.5800 to 0.7466; P < 0.0001) were significantly lower compared to all clinical studies registered in CTG. Interestingly, proportion of late- phase clinical studies, both phase 3 (OR 1.2154; 95 % CI: 1.0668 to 1.3846; P = 0.0034) and phase 4 (OR 1.1927; 95 % CI: 1.0668 to 1.3846; P = 0.0184) were significantly higher compared to all studies registered in CTG.

Conclusion: There were fewer intervention trials in the context of sepsis when compared with all clinical studies registered in CTG. Additionally, funding from the industry and NIH and FA was also lower in sepsis studies compared to overall studies. Further, overtime proportion of the studies funded by industry is reduced though not statistically. Reflection of this is seen in low number of early phase studies. A detailed analysis of the studies with trends and outcomes will be discussed in the main article.

No relevant conflicts of interest to declare.

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2023
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