Clinical Trial Risk in Hepatitis C: Endpoint Selection and Drug Action
Joint Authors
Feld, Jordan J.
Tillie, Nicole A.
Parker, Jayson L.
Source
Canadian Journal of Gastroenterology and Hepatology
Issue
Vol. 2016, Issue 2016 (31 Dec. 2016), pp.1-7, 7 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2016-03-30
Country of Publication
Egypt
No. of Pages
7
Main Subjects
Abstract EN
Background and Aims.
This study analyzed the risk of clinical trial failure of new drugs for hepatitis C between January 1998 and January 2015.
Methods.
Hepatitis C drug development trials that were in phases I–III of clinical trial testing were obtained from the publicly accessible clinical trial repository and other publicly available databases.
Drug compounds were excluded from the study if they began their phase I testing before 1998, if they were not industry sponsored, or if they treated secondary complications of hepatitis C.
Clinical trial success rates were analyzed in comparison to industry expectations.
Further analysis was conducted on the molecule classifications, the mechanisms of action, and the trial endpoints.
Results.
One hundred and twenty-three unique drug compounds were found to fulfill the inclusion criteria, eight of which had FDA approval.
The overall cumulative pass rate for hepatitis C drugs was 20%, which is double the industry expectation rate.
Viral inhibitor small molecule drugs significantly reduced the risk of drug failure during clinical trials compared to other mechanisms of action.
Conclusion.
On average, one in every five drugs that began clinical testing will be approved for market.
Viral inhibitor small molecule drugs are the most promising and hold the least risk.
American Psychological Association (APA)
Tillie, Nicole A.& Parker, Jayson L.& Feld, Jordan J.. 2016. Clinical Trial Risk in Hepatitis C: Endpoint Selection and Drug Action. Canadian Journal of Gastroenterology and Hepatology،Vol. 2016, no. 2016, pp.1-7.
https://search.emarefa.net/detail/BIM-1099901
Modern Language Association (MLA)
Tillie, Nicole A.…[et al.]. Clinical Trial Risk in Hepatitis C: Endpoint Selection and Drug Action. Canadian Journal of Gastroenterology and Hepatology No. 2016 (2016), pp.1-7.
https://search.emarefa.net/detail/BIM-1099901
American Medical Association (AMA)
Tillie, Nicole A.& Parker, Jayson L.& Feld, Jordan J.. Clinical Trial Risk in Hepatitis C: Endpoint Selection and Drug Action. Canadian Journal of Gastroenterology and Hepatology. 2016. Vol. 2016, no. 2016, pp.1-7.
https://search.emarefa.net/detail/BIM-1099901
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1099901