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How Healthy are “Healthy Volunteers?”

September 14, 2017 7:00 am

A recent study (V Takyar et al. Hepatology 2017; 66: 825-33) examined a total of 3160 subjects enrolled in 149 clinical trials from 2011-2015. These patients were derived from the NIH Clinical Center, ≥18 years, had ALT and BMI measurements available. Presumed NAFLD (nonalcoholic fatty liver disease) was classified if patient had elevated ALT (≥20 for women and 31≥ for men) along with BMI >25 kg/m-squared.

Key findings:

27.9% (n=881) of these healthy volunteers had presumed NAFLD. These patients also had higher triglycerides, low-density lipoprotein, cholesterol and HbA1c (P<0.001 for all)
The authors note that the presence of these presumed NAFLD as controls “likely” affected the study validity in 10 studies and “probably” affected another 41 studies.

My take: This study shows that patients with presumed NAFLD are often enrolled in research studies as healthy controls. Furthermore, this can affect study outcomes.

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