A Systematic Review of Race and Ethnicity in Hepatitis C Clinical Trial Enrollment

Area of Science:

• Hepatology
• Clinical Trial Analysis
• Health Disparities

Background:

• The African American/Black population experiences a disproportionate burden of Hepatitis C Virus (HCV) infection in the US.
• This demographic also exhibits lower response rates to existing HCV treatments, highlighting a critical need for inclusive research.

Purpose of the Study:

• To evaluate the participation rates of African American/Black individuals in North American and European HCV clinical trials.
• To compare observed participation with expected rates based on disease prevalence.

Main Methods:

• A systematic review of randomized controlled trials (RCTs) for HCV treatment using interferon-alfa or PEG-interferon, published between 2000 and 2011.
• Data extraction from PubMed, focusing on trials conducted in North America and Europe, with meta-analysis to compare expected versus observed African American/Black participation.
• Analysis of 314 eligible RCTs, of which 123 reported racial data.

Main Results:

• North American trials were more likely to report racial data compared to European trials, with reporting increasing over time.
• A statistically significant underrepresentation of African Americans/Blacks was observed in North American HCV clinical trials relative to the disease prevalence in this population.
• The burden of HCV within the African American/Black community is not adequately reflected in the participant demographics of clinical trials.

Conclusions:

• Current HCV clinical trials in North America do not sufficiently represent the African American/Black population affected by the virus.
• There is a critical need for further research into minority participation in clinical trials and strategies to enhance inclusivity.