An In-Depth Look at How Good Clinical Practices Ensure Ethical Conduct of High Quality Research and the Safety of Study Subjects
LAUSANNE, Switzerland–(BUSINESS WIRE)– Philip Morris International Inc. (PMI) (NYSE/Euronext Paris: PM) today released its latest Scientific Update for Smoke-Free Products, a regular publication on its research efforts to develop and assess a range of smoke-free alternatives to cigarettes. The latest issue of the Scientific Update can be found at this link.
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Philip Morris International Releases Latest Scientific Update for Smoke-Free Products on Clinical Program (Photo: Business Wire)
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and assessment program is inspired by the well-recognized practices of the pharmaceutical industry and in line with the draft guidance of the U.S. FDA for Modified Risk Tobacco Product (MRTP) Applications.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.
About Philip Morris International Inc. (“PMI”)
Philip Morris International Inc. (PMI) is a leading international tobacco company, with six of the world’s top 15 international brands and products sold in more than 180 markets. In addition to the manufacture and sale of cigarettes, including Marlboro, the number one global cigarette brand, and other tobacco products, PMI is engaged in the development and commercialization of reduced-risk products (RRPs). RRPs is the term PMI uses 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 continued smoking. Through multidisciplinary capabilities in product development, state-of-the-art facilities, and industry-leading scientific substantiation, PMI aims to provide an RRP portfolio that meets a broad spectrum of adult smoker preferences and rigorous regulatory requirements. For more information, see our PMI and PMI Science websites.
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