Su1082 Changing Trends in the Characteristics of Gastroenterology Clinical Trials: 2000-2014

Abstract

Sinha Amitasha ,Anand Rohit,Hasan Sayeedul ,Kumar Alok ,Dutta Sudhir K Background: ClinicalTrials.gov is a unique database started in 2000 by National Institutes of Health to register all federally and industry sponsored clinical trials. While prior studies have reported descriptive study of cardiovascular, mental health and oncologic disorders, however to date there is no study on changing trends in the distribution and characteristics of (GI) disorders. Objective: To assess for changes in trends of clinical trials in diseases, registered in the ClinicalTrials.gov database. Since GI trials overlap with oncology. In the current study we included only non-cancer GI trials. Methods: The ClinicalTrials.gov was queried for all trials on non-cancer disorders using terms gastrointestinal NOT cancer on July 11,2014. The content of the registered trials was assessed for disease, intervention, type of trial, funding source and size. Differences in characteristics of clinical trials over time were also assessed using Cochrane Armitage test for trend. Results: A total of 8038 clinical trials dedicated to GI disorders were examined. 110 trials were excluded as they were not related to GI diseases, leaving a total of 7928 trials with a mean number of 39,690 participants in these trials. The number of ongoing clinical trials significantly increased from 115 in year 2000 to 949 in year 2013 (p<0.001), with 96% of total trials registered 2005 onwards. Clinical trials on liver diseases was consistently the top ranked GI disease over the last 10 years accounting for 40% of total trials to date, of which nearly 2/3rds were clinical trials dedicated to viral hepatitis (B,C). The top 3 areas of clinical investigations in non-hepatic GI disorders were: inflammatory bowel disease, gastro-esophageal disorders and cystic fibrosis. NIH/Federal funding has also significantly decreased over the last decade (p<0.001). The size of the federally funded studies was significantly larger than non-federally funded studies (358,054 vs14,672, p<0.01). While IBS (p=0.05) and infectious enterocolitis (p<0.001) were significantly associated with more federal funding, pancreaticobiliary diseases mainly received non-federal funding. During this period non-industry organizations and universities have provided support for 50% of the total trials, while industry supported 36% of the clinical trials as federal funding has diminished. Therapeutic intervention accounted for 54% of the total number of trials. Conclusion: Ours study suggests major shifts in funding trends for clinical trials in USA in the last 15 years. Major changes include reduction in federal support and significant increase in non-federal and industry support for clinical trials.