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Clinical assessment


Clinical studies are a key part of any framework to evaluate any candidate potential modified-risk tobacco products. Clinical research provides information for assessing the health impact of using cigarettes and other tobacco products on humans which would be supported by data from in vitro or other laboratory methods.

Our clinical studies are designed by ourselves, but managed on our behalf by contract research organisations according to the ethical principles of the Declaration of Helsinki (2008) and principles of Good Clinical Practice (GCP) as defined by the International Conference on Harmonisation (ICH ). These studies are initiated only following approval by independent ethics committees and signed informed consent from participating volunteers.

Included within our clinical research program are observational and interventional studies that monitor human smoke toxicant exposure from conventional tobacco products and quantify the efficacy of novel products that aim to reduce toxicant exposure:

  • Observational studies include case-control, cohort and cross-sectional studies (prospective/retrospective)
  • Interventional clinical studies evaluate products intended for human use, to explore or establish the concept of its development as well as the biological effect on users.

The US FDA may support the marketing of innovative tobacco products that substantially reduce or even eliminate toxicity and/or addictiveness of tobacco products. The IoM and US FDA expects that modified risk tobacco products (MRTP) are developed under conditions of strong oversight[1]. The US FDA recommends human studies, as part of a weight of evidence approach, to assess the risk of tobacco use.

Our programme of clinical studies may help to establish some of the biological, physiological and biochemical parameters for assessment of our MRTPs. We register our clinical studies in the International Standard Randomised Controlled Trial Number Register (ISRCTN) before the studies are initiated; such registration forms a commitment to publish the results, irrespective of the outcome, in the scientific literature.

All studies are designed with close involvement of in-house and external statisticians to ensure that they are robust, have the correct number of participants to present reliable results, and that the results are interpreted and reported to the highest standards.

We also wish to establish the influence of behavioural changes on the health impact of changing to a MRTP. Therefore, in addition to trials in which the participants smoke under controlled conditions, we also conduct ‘ad libitum’ trials in which the participants’ smoking behaviour is not prescribed.

Over the last decade GR&D has conducted several clinical studies and an observational study to evaluate Biomarkers of Exposure (BoE), correlation of these BoE to mouth-level exposure (MLE), and the impact of any reduction in toxicant exposure on Biomarkers of Biological Effect (BoBE).

  1. US Food and Drug Administration. 2012. Modified Risk Tobacco Application Draft Guidance .
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