TOBBACCO STUDIES at SOUSEIKAI Global Clinical Research Center address two important current social needs:
1) To help develop potentially safer products for Tobacco consumers who wish to take part in this legal activity.
2) To help those who wish to quit or become less dependent on nicotine and tobacco.
In Japan, some statistics put the smoking rate at around 20%, with approximately 20.59 million smokers. With the increasing trend to quit, better control the habit of nicotine use, and the desire to use safer methods of smoking for the smoker as well as those around them has increased, comes with it the need for clinical trials to gauge the safety of related products. Some of the popular product and study terminology include the following:
|Products:||e-cigarettes , vapor devices , nicotine replacement therapy products, modified-risk tobacco products, reduced risk product (RRP)|
|Studies:||biomarkers of exposure (effect and exposure markers), non-quitting studies, case-control studies, reduced exposure studies, cessation studies|
Clinical studies help to make sure these products and methods are developed in a responsible way. Ultimately, laboratory obtained evidence confirmed in human clinical studies is needed to confirm the safer use of nicotine reduced risk products related to reduced risk exposure.
Studies done in the past at SOUSEIKAI Global have ranged from clinical research relating to tobacco biomarkers such as effect markers and exposure markers, and nicotine pharmacokinetic (PK) studies. Our study experience since 2008 deals with average subject number ranges between 24-180 subjects for studies from 2-4months in duration (including follow-up visits), and can be conducted simultaneously throughout our multi-site Center.
Our 30 years of experience in clinical research in Japan is the foundation upon which we are able to conduct trials of almost any size, type, and complexity in a safe, efficient, and controlled environment. This know-how includes the foresight and process fluidity from access to prepared recruitment panels, to the knowledge base of regulatory compliance and procedures (GCPs, SOPs, IRB).