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 on-site pharmacists 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
Shenif Ladak, MD

Affiliate Tobacco Studies Team

Evgeny Fink, MD
Nick Vatakis, MD

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

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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.

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