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.