Smoking Risk Study
Smoking cigarettes is the one of the most recognised and widely studied risk factors for cardiovascular and lung diseases. Relationship between smoking and health exposure is multidimensional and extremely important socially. Therefore new initiatives are constantly being undertaken, aimed at limit negative effects on people`s health. Potential solution may be the introduction of “Smoke-Free” products, which reduce exposure to harmful and potentially harmful substances, contained in tobacco smoke.
Bio Research is the independent clinical study centre, providing reliable, extensive clinical study on tobacco products and smoking cessation. Clinical studies includes human data on the use and acceptance of the smoke-free products, as well as their potential to reduce exposure to harmful chemicals and reduce the risk of smoking- related diseases as compared to continued smoking.
Each study covers a wide range of medical, laboratory and pharmaceutical procedures, as well as administration and management of the study performed.
Bio Research services includes:
- Study Design & Start-up
- Subjects Recruitment
- Clinical & Scientific Consulting
- IEC & RA submission
- Bioanalysis
- Long-Term storage of samples
- Data Management
- Quality Control & Assurance
- Planning and performing statistical analyses
- Interpreting data
- Medical Writing & Reports
Each research is provided according to the highest quality standards following regulations:
- World Medical Association (WMA) Declaration of Helsinki- Ethical Principles
- of Medical Research Involving Human Subjects,
- ICH – Guideline for Good Clinical Practice,
- Applicable National Regulations.
This approach ensures study continuity and highest accuracy of received data. Our quality procedures, bioanalytical methods and extensive experience allow us to conduct researches, which refers to all stages of tobacco product life cycle: from introduction, through acceptance to its development.
Bio Research provides also smoking cessation studies, aimed to determine characteristics, smoking habits as well as effective therapy for quitting smoking. Subjects participating in the Tobacco Studies are includes in the dedicated Outpatient Smoking Cessation Program, created on extensive medical knowledge and experience. The therapy covers following actions:
Tobacco Studies
Smoking Cessation Study Study Statistics:
- 57 patients recruited within 2 months
- 42 patients enrolled
- After 3 months of the study 23% patients quit smoking
- Drop out <5%
Anti- Tobacco product – Study Statistics:
- 400 patients recruited
- 72 patient enrolled
- >90% of patients quit smoking
- permanently, no medication, only psychological support
- Drop out <5%
| Type of study | Year | Duration | Number of screened Subjects | Number of enrolled Subjects |
|---|---|---|---|---|
| Tobacco product | 2006 | 3 month | ~ 120 | ~ 80 |
| Tobacco product | 2007 | 3 month | ~ 180 | ~ 120 |
| Tobacco product | 2008 | 3 month | ~ 120 | ~ 80 |
| Tobacco product | 2010 | 3 month | ~ 150 | ~ 100 |
| Tobacco product | 2012 | 5 month | ~ 180 | ~ 120 |
| Tobacco product | 2006 | 3 month | ~ 120 | ~ 80 |
| Tobacco product | 2013 | 3 months | ~ 220 | ~ 170 |
| Tobacco product | 2015 | 3 months | ~ 200 | ~ 150 |
| Tobacco product | 2015-2016 | 7 months | ~ 190 | ~ 150 |
| Smoking cessation | 2014-2015 | 1 year | ~ 230 | ~ 157 |
| Anti-tobacco product | 2013-2014 | 8 months | ~ 57 | ~ 42 |
| Anti-tobacco product | 2023 | 9 months | ~ 400 | ~ 72 |
| Novel tobacco product | 2023 | 1 month | ~ 120 | ~ 44 |
| Smoking cessation | 2025 | ongoing | ongoing | ~ 37 |
The Role of Clinical Research in the Development of Novel Nicotine Products
Bridging Innovation with Public Health
The landscape of nicotine consumption is evolving rapidly. Innovative alternatives to combustible tobacco—such as heated tobacco products (HTPs), electronic cigarettes (e-cigarettes), and nicotine pouches—are gaining popularity among adult smokers seeking less harmful options. However, their responsible development, regulation, and public health integration depend on one essential element: robust, independent clinical research.
Understanding Nicotine: Risk and Regulation
Although often misunderstood, nicotine itself is not the primary cause of smoking-related diseases. Scientific evidence shows that the greatest harm stems from toxic compounds produced during combustion. This distinction supports the development of non-combustible nicotine delivery systems. Still, nicotine is a biologically active substance that impacts multiple physiological systems, making clinical assessment of its pharmacokinetics and safety profile across different products vital.
Research helps clarify key questions:
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How efficiently do various devices deliver nicotine?
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What is the impact on biomarkers of exposure?
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Do users fully switch from smoking, or engage in dual use?
These answers inform public health messaging, risk communication, and regulatory decisions.
Heated Tobacco Products and E-Cigarettes
Clinical trials on HTPs show significant reductions (up to 95%) in toxicant exposure when smokers switch completely. Likewise, e-cigarettes have demonstrated both harm reduction potential and smoking cessation efficacy—particularly in randomized trials comparing them to nicotine replacement therapies. However, concerns remain regarding youth use, long-term safety, and the phenomenon of dual use. Ongoing research is essential to evaluate real-world behavior and health outcomes.
Nicotine Pouches: An Emerging Category
Nicotine pouches offer discreet, non-inhaled nicotine delivery. Their appeal among new demographics—including women and young adults—demands careful scientific monitoring. While early studies suggest lower toxicity than traditional smokeless products, long-term data on oral and systemic health effects are still limited. Understanding whether pouches act as a gateway or an exit route from smoking remains a central research priority.
Poland: A Key Hub for Clinical Evaluation
Poland is uniquely positioned in global research on alternative nicotine products. With high smoking prevalence and a complex behavioral landscape involving cigarettes, HTPs, and pouches, the country offers critical insights into real-world harm reduction. Poland also benefits from:
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High-quality research infrastructure,
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Experienced investigators adhering to GCP and EU standards,
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Strong recruitment potential across urban populations.
Polish research centers have already contributed to pivotal international studies and are increasingly generating domestic data on exposure, safety, and behavioral trends. This localized evidence base supports context-specific regulation and enhances Poland’s strategic role in shaping nicotine policy across Europe.