Running clinical studies

      How does PMI run clinical studies?

      We created an internal team of clinical scientists, many of whom joined PMI from the pharmaceutical industry. Together, we have built a clinical program that delivers high-quality clinical research results on our smoke-free products. 

      Aligned with the processes followed by the pharmaceutical industry, our clinical studies are conducted by experienced Contract Research Organizations (CROs) who also conduct studies for pharmaceutical companies. An Institutional Review Board or Ethics Committee reviews and approves each of our studies, serving an important role in the protection of the rights, safety, and well-being of participants.

      The details about all of the clinical studies we are conducting and have conducted are published on the largest online repository of clinical studies, www.clinicaltrials.gov, and can be found in our publications library (filter for publication type: clinical studies). The results from the studies are also published at this repository once the data are obtained and the study reports are finalized.

      All of our clinical studies follow the internationally recognized requirements of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (ICH-GCP). This dictates the quality standards for designing, conducting, and reporting our studies, as well as for protecting the rights, safety, and well-being of study participants.

      All study participants are recruited through our partner CROs. All participants undergo a process of informed consent and selection by the principal investigator using pre-defined inclusion and exclusion criteria as defined in the study protocol.

      From the library
      Reduction in exposure to selected harmful and potentially harmful constituents approaching those observed upon smoking abstinence in smokers switching to the menthol Tobacco Heating System 2.2 for three months (Part 1)
      Switching from cigarettes to THS significantly reduced the exposure to harmful chemicals to levels approaching those observed in subjects who abstained from smoking
      Effects of switching to a heat-not-burn tobacco product on biologically-relevant biomarkers to assess a candidate Modified Risk Tobacco Product: A randomized trial
      Study showed improved biological effects were observed in smokers who predominantly used THS compared with continued cigarette smoking.
      Biological and functional changes in healthy adult smokers who are continuously abstinent from smoking for one year: Protocol for a prospective, observational, multicenter cohort study
      The overall aim of the study was to assess the reversibility of the harm related to smoking over 1 year of continuous smoking abstinence.
      Evaluation of the Tobacco Heating System 2.2. Part 8: 5-Day randomized reduced exposure clinical study in Poland
      PMI's 5-day exposure, controlled, parallel-group, open-label clinical study in Poland.
      Physiological and biological characterization of smokers with and without COPD
      The aim of the study was to comprehensively profile patients with mild-to-moderate COPD and compare the profiles to currently smoking asymptomatic subjects, healthy former smokers, and healthy subjects that had never smoked.
      Evaluation of nicotine pharmacokinetics and subjective effects following use of a novel nicotine delivery system
      In this study, pharmacokinetic profile of nicotine delivered by P3L, a pulmonary nicotine delivery system, and its effects on smoking urges and craving relief in relation to Nicorette inhalator were evaluated.
      Related articles
      Our clinical studies at a glance
      Browse through a list of the clinical studies in our smoke-free product research.
      PMI’s application of best practices to our clinical program
      Read Dr. Patrick Picavet's insights on PMI’s commitment to conducting high-quality clinical research. Explore more in the 4th issue of PMI’s Scientific Update.
      Effects of switching to a heat-not-burn product on biomarkers of potential harm
      Explore how switching to the Tobacco Heating System (THS) impacts biomarkers of potential harm relevant to cancer, COPD, and cardiovascular disease.
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      Reduced exposure to HPHCs in smokers after switching from cigarettes to THS
      Clinical studies show less exposure to harmful chemicals in smokers who completely switch to THS compared with those who continue smoking.
      PMI’s studies on smoke-free products
      Learn more about our scientific assessment program and the results of our research studies on our smoke-free products.
      scientific-approach-people-discussing-percept2.jpg
      Perception and behavior studies
      Understand how we study behavior patterns and risk perception among adult consumers to support an overall positive impact on public health.

      PMIScience.com is operated by Philip Morris International for the purpose of publishing and disseminating scientific information about Philip Morris International’s efforts in support of its smoke-free product portfolio. This site is a global site for use by scientists, the public health and regulatory communities, and other stakeholders with an interest in tobacco policy. The purpose of this site is not advertising or marketing, nor is it directed at any specific market. It is not intended for use by consumers. New tobacco products sold in the United States are subject to FDA regulation; therefore the content of this site is not intended to make, and nor should it be construed as making, any product related claims in the United States without proper FDA authorization. ​
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      Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.