P0002 - Characteristics of Chronic Pancreatitis Clinical Studies Registered in ClinicalTrials.gov Between September, 2007 and May 31, 2023 - A Cross-Sectional Analysis

Akanksha Togra, MBBS, MD¹, Neil Sheth, MBBS, MS², Zhi Cheng, MD^3
1Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, Maharashtra, India; ²Bombay Hospital Institute of Medical Sciences, Mumbai, Maharashtra, India; ³Oklahoma University, Las Vegas, NV

Introduction: Managing chronic pancreatitis is an important unmet medical need. Current study aims to analyze trends and characteristics of chronic pancreatitis (CP) studies registered in ClinicalTrials.gov (CTG).

Methods: All CP studies registered on CTG from September 27, 2007 - May 31, 2022 were identified using Advanced Search feature in CTG. Study characteristics were assessed through relative frequency calculations. Odds ratio and 95% confidence intervals were determined.

Results: Of the 3,85,717 studies registered in CTG during this period, a total of 178 (0.046%) clinical studies were registered for CP. There were 111 (62.6%) interventional studies and 67 (37.4%) observational CP studies. Patient registry studies constituted 7 (3.9%). Interestingly, only one registry study has been completed during this period.
In CP, total 45 (25.3%) studies were funded by the industry, 23 (12.9%) by the National Institute of Health (NIH) and other U.S Federal agencies (FA), and 112 studies (62.9%) were funded by others which included individuals, universities, research organizations etc. Out of ongoing 55 studies in CP, total 7 (12.7%) studies are funded by industry, 11 (20%) are funded by the NIH/ FA, and 37 (67.3%) studies are funded by others. There is more than 50% decrease in the proportion of ongoing studies (indicator of recent studies) funded by the industry in comparison with already completed studies, this difference was significant (OR:0.344, X₂=4.53; p< =0.05). Further, we assessed studies completed and discontinued including terminated, withdrawn and unknown status. NIH/ FA funded studies had completion rates were 83.3% compared to 76.3% for industry sponsored and 52.7% for other sponsored. Discontinuation rates were 16.7% for NIH/ FA funded as compared to 23.7% for industry sponsored and 47.3% studies sponsored by others. Studies were more likely to be completed if funded by NIH (OR 0.365; X₂= 4.53; p< 0.05) or industry (OR 0.3458; X₂= 4.92; p< 0.05) when compared with other funding sources.
A detailed analysis of various types of studies with phases, intervention type and trends was also conducted and will be presented.

Discussion: Number of clinical trials in CP are limited. There are very few Registry studies. Number of studies for CP has increased recently, however, proportion of studies contributed by industry has decreased over time. Studies funded by NIH, FA and Industry have better study completion rates, whereas discontinuation rates were much higher for studies sponsored by all others.


Disclosures:


Akanksha Togra, MBBS, MD¹, Neil Sheth, MBBS, MS², Zhi Cheng, MD³. P0002 - Characteristics of Chronic Pancreatitis Clinical Studies Registered in ClinicalTrials.gov Between September, 2007 and May 31, 2023 - A Cross-Sectional Analysis, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.