The collaboration expands Versiti Clinical Trial Solutions' ability to help sponsors identify and monitor behavioral factors that can affect trial safety, participant retention, adherence and data interpretation. Objective assessment of smoking and alcohol exposure may help reduce protocol deviations, improve cohort selection and strengthen interpretation of study endpoints. Behavioral Diagnostics' assays use DNA methylation-based biomarkers to provide an objective, biology-based measure of risk for lung cancer, smoking intensity and heavy alcohol exposure, helping reduce reliance on self-reported information.
"Clinical trials depend on clean, interpretable data," said Doug Rains, Chief Scientific Officer, Versiti Clinical Trial Solutions. "By adding Behavioral Diagnostics' screening technology to our clinical trial support capabilities, we can help sponsors better understand participant risk factors that may influence safety, adherence and study outcomes."
Behavioral Diagnostics' smoking-related assay evaluates methylation at cg05575921, a biomarker associated with smoking exposure. In a study recently published in Lung Cancer, researchers reported that adding cg05575921 methylation levels to existing clinical and smoking-history variables in subjects from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial improved prediction of lung cancer occurrence in people who currently or previously smoked compared with existing gold-standard methods. In addition, the Smoke Signature CA lung cancer test provides a "hemoglobin A1c-like" assessment of smoking intensity that can be used in Precision Medicine smoking cessation therapies. The findings were especially notable among participants with less than 20 pack-year smoking histories, although the authors noted that additional validation in an external screening population is needed.
The alcohol assay provides an Alcohol T Score, an objective measure associated with heavy alcohol consumption. In clinical trials, unreported or unmonitored alcohol use can introduce safety and data quality challenges, including potential drug-alcohol interactions, participant attrition, missed visits, medication nonadherence and variability that may affect efficacy and safety signals.
Through the partnership, Versiti Clinical Trial Solutions may use the assays to support sponsors with:
- Participant screening and eligibility decisions
- Baseline risk assessment
- Stratification and covariate adjustment
- Longitudinal monitoring of behavioral exposure
- Support for cleaner, more interpretable clinical trial datasets
"Self-report has long been a limitation in assessing behavioral exposure," said Robert Philibert, MD, PhD, Chief Medical Officer and Founder, Behavioral Diagnostics. "Our assays are designed to give sponsors objective biological information that can support more informed trial design, monitoring and interpretation."
The partnership reflects Versiti Clinical Trial Solutions' commitment to offering specialized laboratory and biomarker support that helps sponsors strengthen clinical trial execution while maintaining scientific and regulatory rigor.
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