10 December 2017
PMI releases its latest Scientific Update for Smoke-Free Products, a regular publication on its research efforts to develop and assess a range of potentially reduced-risk alternatives to cigarettes.
This issue of the Scientific Update provides a closer look at some of the principles and practices on which PMI’s scientific assessment program is built. Director Medical Affairs Dr. Patrick Picavet describes specific examples from PMI’s clinical program that highlight the company’s commitment to the implementation of best practices, transparent research and the well-being of clinical trial participants.
Picavet stated, “The performance of clinical studies is a complicated process. Strict implementation of Good Clinical Practices is particularly important to assure the quality and consistency of the research and to address unexpected events that can occur during a study. These Practices are key to the validity of data and the safety of study participants.”
Beyond recent events and publications, this issue also describes PMI’s progress towards sharing all raw data from studies on IQOS in part through the new data-sharing platform called INTERVALS.
Prof. Manuel Peitsch, PMI’s Chief Scientific Officer, elaborates: “PMI is committed to openly sharing the research behind our smoke-free products. That’s why we are using our latest Scientific Update to explain the rigor behind our clinical program. We are going further by gradually making the data and results from the non-clinical and clinical program around our leading smoke-free product, IQOS, available to the public by early 2018.”
PMI’s extensive research and assessment program is inspired by the well-recognized practices of the pharmaceutical industry and in line with the draft guidance of the U.S. FDA for Modified Risk Tobacco Product (MRTP) Applications. PMI employs over 400 world-class scientists, engineers and experts who conduct rigorous research, including laboratory and clinical studies, as well as ground-breaking systems toxicology. The assessment program also includes studies on actual product use and correct understanding of product communications, as well as post-market research.
An important factor of this update is to complement our ongoing efforts to share our latest science. We encourage those who are interested in learning more to explore this website, and follow us on social media platforms @pmiscience.