(1419) Characteristics and Funding of Trials in Sepsis Registered on CTG From September 2007 to June 2023

Sunday, January 21, 2024

9:45 AM – 10:45 AM MT

Location: Connections Central - RST 04

First Author(s)

Neil Sheth (he/him/his)

Research Scholar
n/a

Co-Author(s)

AT

Akanksha Togra, N/A

Resident Physician
Texas Tech University of health sciences El Paso
El Paso, Texas, United States
SM

Satish Maharaj, N/A

Assistant Professor Department of hematology and oncology
Texas Tech University of health sciences El Paso, United States

Introduction:

Purpose: To perform analysis of characteristics, funding by the industry and the NIH of sepsis trials registered in CTG.

Methods: Trials for sepsis on CTG identified using the advanced search feature adding toxemia, infection as search terms and Trial characteristics were assessed by relative frequency calculations. Odds ratio and 95% confidence intervals were determined

Results: A total of 3,909,77 studies were registered in CTG during our time frame. Of these, 0.68%(2,652 studies) were conducted for sepsis. 55.92% were interventional and 44.08% observational studies. The proportion of interventional studies in sepsis was lower than overall(OR 0.4;95 % CI: 0.3618 to 0.4224;P < 0.0001). Also, registry studies were performed in higher number for sepsis than overall(OR 1.75;95 % CI:1.4515to2.1009;P < 0.0001)
441 studies(16.67%) received funding from the industry, 142 studies(5.35%) were funded by the NIH and other U.S FA. 78.92% were funded by all others. Studies funded by the industry and NIH/FA were lower in comparison with the all studies registered in CTG with the industry funding 28.86% and the NIH funding 7.34%. Out of ongoing 628 studies in sepsis, 13.89%(86) studies are funded by the industry, 8.12%(51) were funded by the NIH and other U.S Federal agencies, and 79.1%(485) studies are funded by all others. Ongoing studies funded by industry were lower than those among all registered studies for sepsis(13.82 %;16.67 %), however, this difference was not statistically significant(OR 0.8;95 % CI 0.6239 to 1.0306;P = 0.0846), There was a significant increase in the funding rates by NIH and FA(OR 1.58;95 % CI 1.1350 to 2.2081;P < 0.0001)
The proportion of early phase, 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 studies registered in CTG. Interestingly, proportion 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 in CTG.

Conclusions: Interventional trials in sepsis have been lesser in number. Industry funding is also lower in sepsis trials and has been reducing over time though not statistically. Reflection of this is seen in low number of early phase studies.