title: Methods used in internal industry clinical trials to assess tobacco risk reduction.
abstract: OBJECTIVE
  Methods to assess reduced exposure products should include those that aid in determining likely patterns of human use and exposure. Tobacco industry clinical trial methods may provide insight into strategies to assess potential reduced exposure products (PREP) for public health purposes. Internal tobacco industry documents detailing human clinical research with PREPs were examined to document major research strategies used and identify potentially fruitful methods not currently used in the mainstream arena.
  
  
  METHODS
  Primary data were obtained from records of research conducted internally by tobacco companies and affiliated researchers, and included manuscript drafts, presentations, protocols, and instruments relating to internal clinical trials of human tobacco use and exposure.
  
  
  RESULTS
  Tobacco industry clinical research has focused on reduced exposure products, most notably Premier, Accord, and Eclipse. The most widely used strategy observed is switching studies, and details of study designs and protocols favored by the industry are described. Key measures include biomarkers of exposure (e.g., cotinine, CO, and specific carcinogens) and acute health effects such as physical health and fitness.
  
  
  CONCLUSIONS
  Tobacco industry clinical research has used relatively standard switching study methods, but with a broad set of measures. Clinical switching studies have been conducted by the industry primarily to support existing claims or to develop new claims. Knowledge of prior industry activity can guide and inform future public health research efforts. Although industry clinical trial methods are comparable with current mainstream methods, limited information about the validity of outcome measures used limits their viability for immediate adoption in mainstream science.
authors: Harvard School of Public Health, Boston, MA 02115, USA. vrees@hsph.harvard.edu
authors: Vaughan W
authors: VW
authors: Rees
authors: Jennifer M
authors: JM
authors: Kreslake
authors: Richard J
authors: RJ
authors: O'Connor
authors: K Michael
authors: KM
authors: Cummings
authors: Mark
authors: M
authors: Parascandola
authors: Dorothy
authors: D
authors: Hatsukami
authors: Peter G
authors: PG
authors: Shields
authors: Gregory N
authors: GN
authors: Connolly
mesh_terms: D002986:Clinical Trials as Topic; D003257:Consumer Product Safety / Q000592:standards*; D006801:Humans; D040242:Risk Reduction Behavior; D012907:Smoking / Q000009:adverse effects*; D016540:Smoking Cessation / Q000379:methods*; D019460:Tobacco Industry; D014028:Tobacco Smoke Pollution / Q000517:prevention & control*
chemical_list: D014028:Tobacco Smoke Pollution