Tobacco
“Tobacco use remains the single largest preventable cause of death and disease in the US.”
4
sites with tobacco expertise
25
tobacco studies
20,000+
tobacco user database
From e-cigarette dependence to the correlation of cigarette smoking and depression, tobacco clinical research studies add important information to our understanding of the consequences of tobacco use. ERG sites have honed the specialized expertise and site design needed to optimize patient participation and research outcomes.
Demonstrated Expertise in a Range of Study Types
- Clinical pharmacology studies assessing PK/biomarkers
- Tobacco exposure and abuse potential required for regulatory submission
Tobacco Clinical Research-Specific Expertise
Working with industry-leading principal investigators, our staff is experienced in conducting specialized tobacco trials. They follow clearly delineated protocols to ensure nicotine decontamination. They are trained in urine and saliva collection, serial PK draws, and the collection of time points for ad libitum smoking. And onsite pharmacy teams are skilled in dispensing nicotine products.
ERG’s Experienced Tobacco Studies Team
Jim Aukstuolis, MD
Robert Billingsley, Jr., MD
Gerald Cephas, MD
Otto Dueno, MD
Steven Folkerth, MD
Daniel Gruener, MD
George Konis, MD
Affiliate Tobacco Studies Team
Tobacco Clinical Research-Specific Facilities and Services
With multiple experienced clinical research units, we are able to support the needs of tobacco trials. Our tobacco-experienced sites—which offer the option to separate patient cohorts—have processing labs with centrifuge and appropriate freezer and refrigeration, expertise in spirometry and topography, and in-house imaging. We are actively building these capabilities into additional sites, as well. Across sites, we support these resources with centralized services that create efficiencies. Contracts are negotiated once for all sites; a single campaign of IRB-approved ads can be used across sites.
ERG separates healthy tobacco volunteers from other special populations study participants, even providing separate dining and entertainment areas to avoid cross-contamination.
Targeted Patient Recruitment
Robust recruitment begins with our database of 20,000+ tobacco consumers, spanning all forms of tobacco usage:
- Cigarettes (Menthol and Non-Menthol)
- Electronic Nicotine Delivery Systems (ENDS) using open and closed tanks
- Moist Snuff Tobacco
- Snus
- Multiple delivery systems
- Cigars
Patients are verified using patient identification systems, enabling us to speed trial enrollment. We then pay careful attention to our study participants. We allow tobacco use in dedicated outdoor areas and large indoor spaces with individual air filtration systems—and we offer comfortable facilities, with Wi-Fi, recreational activities, and catered meals. No wonder our average retention rate is 95%.
Spotlight
Clinical research sites with tobacco expertise
Comfortable facilities have dedicated, controlled smoking areas; including indoor smoking rooms with individual air filtration systems, Wi-Fi, recreational activities, and catered meals. Staff have expertise in spirometry and topography.