Incidence of anti-HCV found among clinical trial participants during eligibility screening at NovumPRS from 2005 to 2011

Abstract

Hepatitis C (HCV) is a contagious viral illness and is the most common blood borne infection in the United States. It frequently remains undiagnosed until the ominous symptoms of liver disease, cirrhosis, or hepatocellular carcinoma become evident. This is because most acute infections follow an asymptomatic course. Center for Disease Control (CDC) Viral Surveillance data revealed the incidence rate for hepatitis C in the U.S. to be around 0.3 cases per 100,000. This means that nearly 4 million Americans have been exposed to HCV. World-wide 170 million people are affected by HCV. It is also known that despite these staggering numbers that the majority of HCV infected people go undiagnosed. Novum Pharmaceutical Research Services (NovumPRS) is a private, for profit, Clinical Research Organization (CRO) that has been recruiting and screening adult volunteers for Phase 1 bioequivalence and bioavailability drug studies since the early 1970’s. Three sites collectively completed approximately 150 to 170 studies annually; and screened approximately 90,000 participants during the 2005 to 2011 period we reviewed. In this paper, we present our data regarding the 0.8% positive anti-HCV incidence found on screening laboratory evaluation for clinical trial volunteers prior to consideration for randomized trial enrollment at the three research facilities. Race/ethnicity and socioeconomic status were not considerations made in the reporting of our findings here. A positive anti-HCV test disqualified individuals from participation in all Phase I randomized trials conducted at our research organization not specifically related to hepatitis. All screened participants who tested positive were informed of these findings and appropriate reporting from our research organization to the epidemiology department at the appropriate state health agency was then carried out.

Keywords: Hepatitis, hepatitis C, trials, volunteers, screening, clinical research organization.

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